Digital Lab Portfolio

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MEDLINE LAB PORTFOLIO GET STARTED


Lab Portfolio Lab Lead Form HbA1c and Glucose

HbA1c and Glucose Siemens DCA Vantage 0700731_DCA_Vantage_Brochure.qxd

11/16/07

5:47 PM

Afinion 2 Analyzer

Afinion HbA1c

Lipid Profile

Medline POC Influenza A & B / RSV

Tosoh G8

Page 2

C A R D I O M E TA B O L I C

Strep

C A R D I O M E TA B O L I C

HPLC ANALYZER Gold Standard Accuracy by Ion-Exchange HbA1c SIMPLY MORE EFFICIENT.

ALERE AFINION HbA1c ™

SIMPLY MORE EFFICIENT.

AFINION 2 ANALYZER ™

Consultations with patients who do not have their lab results are challenging and inefficient. Point-of-care HbA1c testing can improve operational efficiency and lead to increased patient motivation and satisfaction.1-4 Precise Chromatographic Detail

The Afinion 2 Analyzer is the result of years of continuous product innovation and refinement, and delivers actionable pointof-care test results in just minutes.

See Diabetes Care from a Whole New Perspective

Additional POC

n

3-minute test time

n

Lab-quality results

n

DCA Vantage™ Analyzer

FDA Cleared to Diagnose Diabetes

No interference from common Hb variants

n

NGSP and IFCC certified

n

CLIA waived

TOSOH BIOSCIENCE Siemens Medical Solutions Diagnostics

Urinalysis Hematology

Adams A1c

Medline Harmony

Medline EVENCARE ProView

Medline EVENCARE G3

Chemistry Superior Performance, Proven Technology

Immunoassay

Improve patient care with the ADAMS™ A1C HA-8180V. The easy-to-use, automated hemoglobin A1C analyzer with diagnosis claims employs gold standard HPLC technology. The analyzer generates quality results and provides superior precision to accurately report HbA1C and aid physicians with: • Diagnosing diabetes • Identifying patients at increasing risk for diabetes • Monitoring blood glucose control

Global Market Leader

Quality Results

Easy-to-Use

• ADAMS A1c brand has been used globally for decades

• Lowest NGSP precision claims on the market (≤1% CVs)

• ARKRAY introduced the first fully automated HPLC HbA1c analyzer in 1981

• Gold standard HPLC technology provides superior precision*

• Intelligent result review eliminates routine chromatogram review

• Eighth generation of ADAMS technology

• Eliminates interference with the most common hemoglobin variants (HbC, HbS, HbD, and HbE)

• No sample mixing or pre-treatment required • Continuous sampling – load racks and walk away! • Integrated column and pre-filter reduces maintenance

MANY PATIENTS. ONE GLUCOSE MONITOR.

EASY TO READ. EASY TO USE.

TRUST THE NUMBERS.

FPO

* Diabetes Control and Complications Trial

Harmony™ Blood Glucose Monitoring System Designed with accuracy in mind

EVENCARE® ProView™

Specialty

EVENCARE® G3 Blood Glucose Monitoring System

Simple and Accurate Diabetes Management for Resident Care

ESR Medline EVENCARE G2

Blood Gas Coagulation

SIMPLIFIED DIABETES MANAGEMENT.

Cardiac

EVENCARE® G2™

Blood Glucose Monitoring System

LIS/Resources Forms


Lab Portfolio

0700731_DCA_Vantage_Brochure.qxd

Siemens DCA Vantage

11/16/07

5:47 PM

Page 2

Siemens DCA Vantage Albumin & Creatinine AMV6011Z | 10 ea/bx L20.8.60.5.17 82044QW & 82570QW $11.41

Placement Agreement

Siemens DCA Vantage A1c AMV5035Z | 10 ea/bx L20.8.55.8.60 83036QW $9.71

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas

See Diabetes Care from a Whole New Perspective

Coagulation

Cardiac

DCA Vantage™ Analyzer LIS/Resources Siemens Medical Solutions Diagnostics

Forms


Lab 0700731_DCA_Vantage_Brochure.qxd Portfolio Siemens DCA Vantage

11/16/07

5:47 PM

Siemens DCA Vantage Albumin & Creatinine AMV6011Z | 10 ea/bx L20.8.60.5.17 82044QW & 82570QW $11.41

Page 3

Placement Agreement

Siemens DCA Vantage A1c AMV5035Z | 10 ea/bx L20.8.55.8.60 83036QW $9.71

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Take a New Look at Diabetes Care With the Enhanced Patient Management of the New DCA Vantage Analyzer ��� ��� ������� �������� �� ��� �������� ������ ���� �������� ���������� ������, ���������� �������� ���1� ��� ��� ����� ������� ����� �� ������� ������� ����������.1 ���� ������ ������ �� ��� �� ���� ������ ���, ��� ��� �������� ������ �� ������� ���-������� ����������� �� �����-��-���� ����������� �����. �� ��� �� ����� �������, ������ ��� ��� ���� ��������� ��� �� ������ ���� ��������.

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Quantitative Tests ���1�* �������

HbA1c CLIA-waved

Blood Gas Coagulation

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Cardiac

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LIS/Resources Forms


Lab Portfolio

0700731_DCA_Vantage_Brochure.qxd

Siemens DCA Vantage

11/16/07

5:47 PM

Page 4

Siemens DCA Vantage Albumin & Creatinine AMV6011Z | 10 ea/bx L20.8.60.5.17 82044QW & 82570QW $11.41

Placement Agreement

Siemens DCA Vantage A1c AMV5035Z | 10 ea/bx L20.8.55.8.60 83036QW $9.71

Lab Lead Form HbA1c and Glucose

Lipid Profile Clinical Confidence with the DCA Vantage Analyzer • Highlighted in over 100 clinical articles • Used by three out of four physicians who perform HbA1c testing in the office • Proven system with a 12-year track record

Medline POC Influenza A & B / RSV

Strep

Additional POC How can you tighten glycemic control?2

How can you improve patient compliance?

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DCA Vantage Analyzer Point-of-Care Immunoassay Analyzer for Diabetes Management

Urinalysis

Quantitative Test Menu � ���1� �� ����� ����� �� ��� ������� � �������, ����������, ��� ��� ����� �� ����� �� ����� �������

Hematology

Simple to Use � �� ������ �� ������� ����������� �������� � ���� ��������� ���� ������ ���� ������ ��� ���� ���� � ������������� ��������� ������� Flexible Patient Data Management � ����� �� ������� ��/���� ��� �������� �� ���� ����� ������ �� �������� ������� � �������� ������ ���������� ��������, ��������� ������� ������� ������, �������� �������, ���/�� �������� �� ���/��� � ������� ������ �� �000 ������� ���� �������� ������� ������������ � ���� �������� �� ������� �������� ���� ��� ����� ����� �� ��

Are you effectively monitoring diabetes complications? ��� ������� �������� �������� ��� ��-����� �������, ����������, ��� ��� ����� ������� ���� ���-������� ����������� ��� �����������. ������ ����, ���� �� ������� ��� ���������� ��� ����� ��� ��������, �� ����� ���� � ������� ��� ������ ������ ������� ������� � ������� ������� ���� � ��������� ����

��� �����! ������� ������� ������ ��� �������� ������� ����� �����

Testing Compliance in Point-of-Care Coordinated Sites � �������� ������� ������� ��������� ��������� ��������� �� ���� ������� � ������ ������ ��� ����������� �� ��� ������������ � ���������� ����������� �� ��������� ������ � ����-������� ��������� ������ ����� �� ������� ����������

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab 0700731_DCA_Vantage_Brochure.qxd Portfolio

11/16/07

Siemens DCA Vantage

5:47 PM

Siemens DCA Vantage Albumin & Creatinine AMV6011Z | 10 ea/bx L20.8.60.5.17 82044QW & 82570QW $11.41

Page 1

Placement Agreement

Siemens DCA Vantage A1c AMV5035Z | 10 ea/bx L20.8.55.8.60 83036QW $9.71

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis ������� ������� ��������� ����������� ������ � ����� ��������� �� �����������-������ ���������� ��������� ���� ������� ���� ��������� ���� �� ������ �� ��� ���������, ����������, ��� ���������� �� �������. ��� �������� ��� �������� ����� �������� ��� ����� ������� �� �������, ����������, ��� ������������ ������ ��� ���������� ��������� �� ������� ������� ������������� ���� ��� ����� ����������� ���� ���� �� ������� ������, ���� ������������ ���� �� �������� ������ ��� �����.

� 200�, ������� ������� ��������� ����������� ����� ��. ��1��-0�00��1-�2-��00 ������� �� ��� ��� ������� ��� ��� ���������� ����� ��� ���������� �� ������� ������� ��������� �����������. ��� ����� ���������� ��� ������ ��� ��� �������� �� ����� ���������� ������.

References 1. �������� �, ������ ��, ������ ��. ��������� �������� �� ���1� ������ �������� �������� ������� �� ���� 1 ��� �������-������� ���� 2 �������� ��������. �������� ���� 1���� 22�1���-�. 2. ������ �, ����� �, ������� �, ������������ �. ���� ������� ������� �� �������� �������� ���������� ��� ����� ��� ��������. ������ ��������� ������ 1�����(1�)�1-��. �. ������ ��, ������ ��, ������� ��, ���� ��, ������ ��, �������� ��, ��-����� ��. �������� �� ����� �������-���������. ����. ������������ �� ����� ���1� ������������ �������� �������� ��������-������. �������� ���� 1����22�1�1�-21. �. ������ ��, ������ ��, �������� ��, ������ ��, ������� ��, ���� ��, �� ��. ����� �1� ������������ �������� �������� ��������-������ �� �� ����� ������� ���� ������. �������� ���� 200��2��11��-��.

������� ������������ ��� ���� ���� ������� �� ������� ��� �� ������� �� ������� ���������� ������������. ������ ������� ���� ����� �������������� ��� ������������.

Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Siemens Medical Solutions Diagnostics 1�1� ��������� ���� ���������, �� �001�-��00 ���

Coagulation

Cardiac LIS/Resources www.siemens.com/diagnostics

Forms


Lab Portfolio

Alere Afinion A1c ALR1116974 | 15 ea/bx L20.8.72.9.57 83036QW $9.71

Alere Afinion ACR ALR1116972 | 15 ea/bx L20.8.37.9.57 82044QW & 82570QW $11.41

Lab Lead Form

Afinion 2 Analyzer

HbA1c and Glucose

C A R D I O M E TA B O L I C

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

SIMPLY MORE EFFICIENT.

AFINION 2 ANALYZER ™

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

The Afinion 2 Analyzer is the result of years of continuous product innovation and refinement, and delivers actionable pointof-care test results in just minutes.

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Alere Afinion A1c ALR1116974 | 15 ea/bx L20.8.72.9.57 83036QW $9.71

Alere Afinion ACR ALR1116972 | 15 ea/bx L20.8.37.9.57 82044QW & 82570QW $11.41

Lab Lead Form

Afinion 2 Analyzer

Afinion 2 Analyzer

HbA1c and Glucose

ABOUT

BENEFITS TO POINT-OF-CARE TESTING

With its compact size and panel of tests, the Afinion 2 system is ideal for point-of-care testing in physician offices, clinics, community health centers and hospital out-patient clinics. From just a small urine or fingerstick whole blood sample, lab-accurate results for ACR and HbA1c are made available during the consultation.

Lipid Profile

Reduced workload in the practice:1 n Fewer follow-up calls

Medline POC

n Fewer follow-up letters n Fewer patient revisits

More informed decision-making improves patientclinician relationships, patient motivation and attitude.2

Influenza A & B / RSV

Afinion2 Procedurals - HbA1c

3-STEP PROCEDURE

1

Afinion2 Procedurals - HbA1c

2

Collect the sample with the integrated sampling device.

Place the sampling device back in the test cartridge.

3

Strep Afinion2 Procedurals - HbA1c

Place the test cartridge in the analyzer and close the lid. The processing starts automatically.

Additional POC

Urinalysis Hematology

Chemistry

Afinion HbA1c Procedure_Cartridge Tube

TESTS

Afinion HbA1c Procedure_Sample Finger

Afinion tests can be used with both the Afinion 2 Analyzer and the Alere Afinion AS100 Analyzer.

FACTS n Size: 7.2 x 7.5 x 13.0 (in)

Afinion HbA1c Procedure_Insert Cartridge

Immunoassay

n Weight: 7.5 lbs. n LCD color touch display n Patient/Operator ID and Patient/Control

Specialty

results stored in memory

n No maintenance required

ESR

n No operator calibration

ALERE AFINION™ HbA1c

ALERE AFINION™ ACR

n Extensive and comprehensive failsafe systems

prevent the possibility of erroneous results

Blood Gas

n QC and operator lockout

Coagulation

CONNECTIVITY The Afinion 2 Analyzer can reliably transfer test results to an information system. The Afinion 2 Analyzer connectivity automatically transfers patient and control results via an Ethernet cable to a connected LIS/HIS system via TCP/IP networking using the protocols POCT1-A, HL7, ASTM 1381-

85 (low level) or ASTM 1394-97 (high level), selectable by configuration. With built-in connectivity the Afinion 2 Analyzer can communicate with LIS and HIS systems to share and manage data more effectively, contributing to better patient management everywhere.

1. Crocker JB, Lee-Lewandrowski E, Lewandroski N, et al. Implementation of point-of-care testing in an ambulatory practice of an academic medical center. Am J Clin Pathol. 2014;142:640-6. 2. Laurence CO, Gialamas A, Bubner T. Patient satisfaction with point-of-care testing in general practice. Br J Gen Pract. 2010;60(572): e98–e104.

© 2018 Abbott. All Rights Reserved. Afinion is a trademark of the Abbott group of companies. All other trademarks referenced are trademarks of their respective owners. 10003941-02 05/18

Cardiac LIS/Resources Forms


Lab Portfolio

Alere Afinion A1c ALR1116974 | 15 ea/bx L20.8.72.9.57 83036QW $9.71

Lab Lead Form

Afinion HbA1c

HbA1c and Glucose

C A R D I O M E TA B O L I C

Lipid Profile

Medline POC Influenza A & B / RSV

Strep SIMPLY MORE EFFICIENT.

ALERE AFINION HbA1c

Additional POC

Consultations with patients who do not have their lab results are challenging and inefficient. Point-of-care HbA1c testing can improve operational efficiency and lead to increased patient motivation and satisfaction.1-4

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR

n

3-minute test time

n

Lab-quality results

n

No interference from common Hb variants

n

NGSP and IFCC certified

n

CLIA waived

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Alere Afinion A1c ALR1116974 | 15 ea/bx L20.8.72.9.57 83036QW $9.71

Lab Lead Form

Afinion HbA1c

HbA1c and Glucose

Alere Afinion HbA1c ™

FACTS

CONNECTING DIABETES & CARDIOVASCULAR DISEASE

Lipid Profile

The Alere Afinion HbA1c is a simple fingerstick test that provides a patient’s HbA1c value within minutes, during the consultation.

The 3-minute Alere Afinion HbA1c testing fits perfectly within the workflow:

n 1.5 μL sample volume

—Egbunike V et. al. Diabetes Educator. 2013;39:66-73.

n Capillary and venous whole blood

“Point-of-care testing for HbA1c provides the opportunity for more timely treatment changes.”

sample material n Measuring range: 4-15% HbA1c

“Point-of-care HbA1c testing represents an opportunity for improved care of people with diabetes.”

Medline POC Influenza A & B / RSV

—ADA. Diabetes Care 2018;41(Suppl. 1):S55–S64.

Strep

n 3 months room temperature storage n Ready to use controls in 2 levels

Additional POC Afinion2 Procedurals - HbA1c

3-STEP PROCEDURE

1

Collect the sample with the integrated sampling device.

Afinion2 Procedurals - HbA1c

2

Place the sampling device back in the test cartridge.

3

Afinion2 Procedurals - HbA1c

Place the test cartridge in the analyzer and close the lid. The processing starts automatically.

Urinalysis Hematology

Chemistry

Immunoassay

Afinion HbA1c Procedure_Cartridge Tube

Specialty

AVAILABLE TESTS

NEW AFINION 2 ANALYZER Afinion HbA1c Procedure_Sample Finger

The Afinion 2 Analyzer is the result of years of continuous product innovation and refinement and delivers actionable point-of-care test results in just a few minutes.

Afinion HbA1c Procedure_Insert Cartridge PRODUCT NAME

PRODUCT CODE

ALERE AFINION™ HbA1c

1115015

ALERE AFINION™ ACR

1115120

With its compact size and short test times, the Afinion 2 system is ideal for point-of-care testing in physician offices, clinics, community health centers and hospital outpatient clinics. From just a small urine sample or fingerstick whole blood sample, lab accurate results for ACR and HbA1c are made available during the consultation.

ESR Blood Gas Coagulation

Cardiac LIS/Resources

1. 2. 3. 4.

Shepard MD. Clin Biochem Rev. 2006;27(3):161-70. Laurence CO, Gialamas A, Bubner T. Br J Gen Pract. 2010;60(572):e98-e104. Miller CD, Barnes CS, Phillips LS, et al. Diabetes Care. 2003;26(4):1158-63. Crocker JB, Lee-Lewandrowski E, Lewandroski N, et al. Am J Clin Pathol. 2014;142:640-6.

© 2018 Abbott. All Rights Reserved. Afinion is a trademark of the Abbott group of companies. All other trademarks referenced are trademarks of their respective owners. 10003943-03 07/18

Forms


Lab Portfolio Lab Lead Form

Tosoh G8

HbA1c and Glucose

Lipid Profile

Medline POC

HPLC ANALYZER Gold Standard Accuracy by Ion-Exchange HbA1c

Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR

Precise Chromatographic Detail

Blood Gas

FDA Cleared to Diagnose Diabetes

Coagulation

Specialty LIS/Resources

TOSOH BIOSCIENCE Forms


Lab Portfolio Lab Lead Form

Tosoh G8

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Features and Benefits Trusted • Gold Standard HPLC • First HPLC Analyzer approved by the FDA to diagnose diabetes • NGSP and IFCC Certified Clinically Superior • Directly measures stable and labile HbA1c • Less than 2% CVs • Flag level sophistication with increasing severity • 20 customizable, user defined flags to assist with auto-verification User Friendly, Flexible and Efficient • Cap-piercing of primary tubes (1 mL minimum volume) • Whole blood (50 uL minimum volume) • Diluted samples (150 uL minimum volume) • Various primary tube sizes 12-15 mm x 75-100 mm • Batch or STAT mode • Minimal maintenance • Individual consumables – No kits • 2500 injection column warranty • Compact Footprint – 21” w x 20” d x 19” h • Optional Reporting Software System for QC, result storage and multiple reporting options Fast • 1.6 minutes (96 seconds) per result • 37 tests/hour throughput • 3.5 minutes to first result from cold start • 90 or 290 sample capacity with continuous loading

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Specialty LIS/Resources Forms


Lab Portfolio Tosoh G8

Lab Lead Form HbA1c and Glucose

Tosoh G8 - The Gold Standard Accurate and Precise HPLC Technology High Performance Liquid Chromatography (HPLC) is considered the “Gold Standard” technology in the follow-up of the plasma glucose concentration of diabetic patients, via the measurement of HbA1c. Tosoh’s G8 is the first HPLC analyzer cleared by the FDA to also diagnose diabetes.

Lipid Profile

Medline POC Influenza A & B / RSV HPLC Column Strep

Through Tosoh’s development of a non-porous ion-exchange column, HbA1c results are directly measured and not clinically affected by the presence of most hemoglobin variants or hemoglobin derivatives.

Additional POC

Direct Measurement vs. Calculation of HbA1c The Tosoh G8 directly measures HbA1c along with each individual hemoglobin fragment. Elevated fetal hemoglobin (HbF), which may cause erroneous measurement, occurs in approximately 7.5% of the diabetic population. The G8 separates and identifies HbA1c even in the presence of elevated HbF. As you can see from the chromatogram on the right, the user will be alerted if the HbF concentration is too high to report the HbA1c.

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

In contrast, other methods such as boronate affinity and immunoassay measure only total hemoglobin. A calculation is used to differentiate the HbA1c from the glycated hemoglobin variants and HbF rather than directly measure HbA1c.

ESR Blood Gas

The ability of the G8 to directly measure HbA1c and to identify HbF and other hemoglobin fragments is what truly gives confidence in the quality of the reported result.

Coagulation

Specialty LIS/Resources

Chromatogram for patient with elevated HbF

Forms


Lab Portfolio Lab Lead Form

Tosoh G8

HbA1c and Glucose

Be Proud of Your Performance Trust Tosoh The G8 provides direct determination of stable HbA1c with less than 2% CVs. The G8’s low x bar z= -2.941176 A= 0.001634841 CVs inspire confidence in the reliable quality of results. As seen below, plus 2SD z =HbA1c 0.4615385 A= a small 0.0228 minus 2SD Z -3.538462 A= results. 0.9773 difference in CV can create a large gap in quality. With Tosoh you can trust your Probability that a patient is really meeting a goal HbA1c of 7% if HbA1c of 6.8% is measured using a method with a certain CV

Lipid Profile

Medline POC Influenza A & B / RSV

Lower CVs Mean Higher Confidence in Your Results 100%

Strep

G8

90%

Additional POC

oh

85% 80%

To s

75% 70% 65%

Urinalysis

60% 0%

1%

2%

3%

4%

CV

5%

6%

7%

8%

CV (Imprecision) (Imprecision)

“...we can be quite confident (93% probability) that the patient is actually meeting the ADA goal if his or her A1C is 6.8% when the assay CV is 2%. We are less confident (72% probability) when the assay CV is 5% and not nearly confident enough (64% probability) when the assay precision is as high as 8%.” Little & Rohlfing, DT&T, 2003, 5(6): 979-981

Hematology

Chemistry

Immunoassay

Less is More: Effects of Precision on HbA1c With less overlap you can be confident of your HbA1c results for diagnosis of diabetes. 9.5 %

Specialty

9.0 %

ESR

8.5 %

8.0 %

7.5 % 7.0 %

6.5 %

6.0 %

Blood Gas

Incidence of Diabetes

HbA1c

Probability Probability

95%

Coagulation

Specialty

5.5 %

5.0 %

1%

Tosoh G8

2%

3%

4%

5%

6%

7%

8%

LIS/Resources

Average Industry Performance CV (Imprecision)

Forms


Lab Portfolio Lab Lead Form

Tosoh G8

HbA1c and Glucose

On-Point and On-Time Lipid Profile

Reporting Software - Sophisticated Simplicity The G8 Reporting Software highlights flagged results based upon the 20 user-defined parameters which are set-up in the G8 analyzer. This allows the user to quickly identify and accept all non-flagged results to assist with auto-verification. Levey-Jennings

Flagged results will be highlighted and these “abnormal” results can be investigated in real time via detailed chromatograms and patient-specific trend analysis. Added features include customizable database management, flexible chartable reporting, result tracking by lot, Levy-Jennings and Westgard rules, inventory management and much more.

Trend

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Specialty LIS/Resources

Result Report - 1 Chromatogram

Result Report - 6 Chromatogram Forms


Lab Portfolio Lab Lead Form

Tosoh G8

HbA1c and Glucose

Specifications Analytes Principle Sample requirement Sampling volume Throughput Data storage

Main unit Sampling Whole blood Column oven Colulmn connection Detector unit Sample loading units Sample loading capacity

Lipid Profile

HbA1c (SA1c), HbF, HbA1 (Total A1) Ion-exchange high performance liquid chromatography Visible two-wavelength absorption Whole blood or diluted blood (Preserved with EDTA) Whole blood: 4 mL Diluted blood: 80 mL 1.6 minutes per sample On-board memory: up to 800 samples Unlimited storage with Reporting Software

Medline POC Influenza A & B / RSV

Cap-piercing of primary sample tubes Automatic dilution by Hemolysis and Wash solution in the dilution port Thermomodule in aluminum block Finger-tight type LED colorimetric detector

Strep

G8-90SL: 90 samples plus one STAT sample G8-290SL: 290 samples plus one STAT sample

Sample holding

10 samples/rack

Sample specifications

12-15 mm x 75-100 mm primary tubes and Tosoh sample cups

Barcode specifications

NW-7, CODE39, ITF, CODE128, JAN, COOP 2 of 5, Industrial 2 of 5

Additional POC

Urinalysis

System control/Data processing Display & Input Liquid crystal display touch panel Output

Thermal printer (roll paper), SmartMedia or LIS

Communication

RS-232C standard serial (bi-directional)

Operating temperature

15 - 30 C

Power requirement

AC 100 - 240 V, 50/60 Hz, 180 VA

Dimensions/Weight

90SL model: W 21" (530 mm) x D 20" (515 mm) x H 19" (482 mm) 75 lbs (34.0 kg) 290SL model W 44" (1120 mm) x D 21" (530 mm) x H 19" (482 mm) 114 lbs (51.5 kg)

o

Hematology

Chromatogram for non-diabetic patient sample

Chemistry

Immunoassay

Specialty

90SL Line Automation model available.

ESR

G8 90 Sample Loader

Please contact your local Tosoh representative for further information.

Blood Gas Coagulation

Specialty Tosoh Bioscience, Inc. 6000 Shoreline Court, Suite 101 South San Francisco, CA 94080 Tel: (800) 248-6764 Fax: (650) 615-0415 www.tosohbioscience.us

G8 290 Sample Loader

LIS/Resources Forms


Lab Portfolio Lab Lead Form

ADAMS A1c

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Superior Performance, Proven Technology Improve patient care with the ADAMS™ A1C HA-8180V. The easy-to-use, automated hemoglobin A1C analyzer with diagnosis claims employs gold standard HPLC technology. The analyzer generates quality results and provides superior precision to accurately report HbA1C and aid physicians with: • Diagnosing diabetes • Identifying patients at increasing risk for diabetes • Monitoring blood glucose control

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay Global Market Leader

Quality Results

Easy-to-Use

• ADAMS A1c brand has been used globally for decades

• Lowest NGSP precision claims on the market (≤1% CVs)

Specialty

• ARKRAY introduced the first fully automated HPLC HbA1c analyzer in 1981

• Gold standard HPLC technology provides superior precision*

• Intelligent result review eliminates routine chromatogram review • No sample mixing or pre-treatment required

ESR

• Eighth generation of ADAMS technology

• Eliminates interference with the most common hemoglobin variants (HbC, HbS, HbD, and HbE)

• Continuous sampling – load racks and walk away! • Integrated column and pre-filter reduces maintenance

Blood Gas Coagulation

Cardiac LIS/Resources * Diabetes Control and Complications Trial

Forms


Lab Portfolio

Harmony Meter MPH6540 1/ea N/A

Placement Agreement

Medline Harmony

Harmony Test Strips MPH6550Z 50 ea/bx 19.0.30.53.33 82962 $3.28

Harmony Control Solution MPH6560Z 1/ea 19.8.63.36.27

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR

TRUST THE NUMBERS.

Blood Gas Coagulation

Cardiac LIS/Resources

Harmony™ Blood Glucose Monitoring System Designed with accuracy in mind

Forms


Lab Portfolio

Harmony Test Strips MPH6550Z 50 ea/bx 19.0.30.53.33 82962 $3.28

Harmony Meter MPH6540 1/ea N/A

Placement Agreement

Medline Harmony

Harmony Control Solution MPH6560Z 1/ea 19.8.63.36.27

Lab Lead Form HbA1c and Glucose

Accuracy improves care. Stand out as a leader in resident care with our new Harmony Blood Glucose Monitoring System, which meets many Food and Drug Administration (FDA) recommendations.

Lipid Profile Automatic coding ensures minimal errors and accurate results

Medline POC Influenza A & B / RSV

Results in 8 seconds

Strep Test strip ejector eliminates contact with used test strip

Special features » Test strips are designed to limit interference with therapies such as oxygen » Ideal for higher acuity residents with a wider hematocrit test range

Additional POC

Urinalysis

Get ongoing support » Easy-to-follow manual and in-service training

Hematology

» Online diabetes education curriculum with 24/7 access » Toll-free technical service hotline 1-866-274-2131

Large, backlit display can be clearly read in low light

Ordering Information Item No.

Description

Pkg.

MPH6540

Harmony Glucose Meter

1/ea

MPH6550Z Harmony Test Strips

50/bx

MPH6560Z Harmony Control Solution

1/bx

Chemistry

Immunoassay

Specialty

Actual size

ESR Trust the numbers. Contact your Medline Representative for more information and a product demonstration.

Blood Gas Coagulation

Medline Industries, Inc. Three Lakes Drive, Northfield, IL 60093 Medline United States 1-800-MEDLINE (633-5463)

medline.com | info@medline.com

Medline Canada 1-800-396-6996

medline.ca | canada@medline.com

FOLLOW US

Medline México 01-800-831-0898

BLOG

Cardiac

medlinemexico.com | mexico@medline.com

Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this brochure. © 2018 Medline Industries, Inc. All rights reserved. Harmony is a trademark and Medline is a registered trademark of Medline Industries, Inc. MKT1887859 / LIT898R / 2.85M / SG / 3

LIS/Resources Forms


Lab Portfolio Medline EVENCARE ProView

EVENCARE Proview Meter MPH4540 1/ea N/A

Placement Agreement

EVENCARE Proview Test Strips MPH4550Z 50 ea/bx 19.0.18.50.93 82962 $3.28

EVENCARE Proview Control Solution MPH4560Z 1/bx 19.4.81.34.41

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR

EASY TO READ. EASY TO USE.

Blood Gas Coagulation

Cardiac LIS/Resources

EVENCARE® ProView™

Simple and Accurate Diabetes Management for Resident Care

Forms


Lab Portfolio

EVENCARE Proview Meter MPH4540 1/ea N/A

EVENCARE Proview Test Strips MPH4550Z 50 ea/bx 19.0.18.50.93 82962 $3.28

Lab Lead Form

Placement Agreement

Medline EVENCARE ProView

EVENCARE Proview Control Solution MPH4560Z 1/bx 19.4.81.34.41

HbA1c and Glucose

ENGINEERED FOR ACCURACY AND SIMPLICITY.

Lipid Profile

Medline POC Influenza A & B / RSV

When it comes to managing your residents' diabetes, monitoring and tracking blood sugar levels is fundamental. So it’s important that caregivers have a glucose meter that’s approved for use in long-term care facilities. One that can be easily used by new and experienced staff.

Strep

Additional POC

EVENCARE ProView gives you an easy-to-read meter that delivers quick, accurate results from a tiny blood sample. It requires no coding and is backed by industry-leading support.

Urinalysis

Simple to Operate » Large, backlit display can be clearly read in low light » Ergonomic design has a comfortable, non-slip grip

Hematology

» Test strip ejector eliminates contact with used strip » Automatic coding ensures minimal errors and accurate results » Results in 5 seconds

Chemistry

Easy on Residents » Allows alternative site testing: fingertips, forearm, palm » Small sample, only 0.5 μL, lessens discomfort

Ordering Information Item No.

Description

Pkg.

Ongoing Support

MPH4540

Glucose Meter

1/ea

» Easy-to-follow manual guides staff through proper use of the meter and provides in-service training

MPH4550

Test Strips

50/bx, 12 bx/cs

» Online curriculum through Medline University gives staff 24/7 access to a growing list of diabetes education courses

MPH4550Z

Test Strips

50/bx

MPH4560

Control Solution High/Low

6 bx/cs

MPH4560Z

Control Solution High/Low

1/bx

MPHBKECR2032

Replacement Batteries, 3V 2032

6 ea/cd

» Toll-free technical service hotline 1-866-274-2131

Immunoassay

Specialty

ESR Contact your Medline Representative for more information and a product demonstration.

Blood Gas Coagulation

Medline Industries, Inc. One Medline Place, Mundelein, IL 60060 Medline United States 1-800-MEDLINE (633-5463)

medline.com | info@medline.com

Medline Canada 1-800-396-6996

medline.ca | canada@medline.com

FOLLOW US

Medline México 01-800-831-0898

BLOG

Cardiac

medlinemexico.com | mexico@medline.com

Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this brochure. © 2016 Medline Industries, Inc. All rights reserved. ProView is a trademark and EVENCARE and Medline are registered trademarks of Medline Industries, Inc. MKT1670163 / LIT714R / 2.5M / NPN / 3

LIS/Resources Forms


Lab Portfolio

EVENCARE G3 Meter MPH3540 1/ea N/A

Medline EVENCARE G3

Placement Agreement

EVENCARE G3 Test Strips MPH3550Z 50 ea/bx 19.0.22.31.22 82962 $3.28

EVENCARE G3 Control Solution MPH3560Z 1/bx 19.8.54.34.07

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR

MANY PATIENTS. ONE GLUCOSE MONITOR.

Blood Gas Coagulation

Cardiac LIS/Resources

FPO

EVENCARE® G3

Blood Glucose Monitoring System

Forms


Lab Portfolio

EVENCARE G3 Test Strips MPH3550Z 50 ea/bx 19.0.22.31.22 82962 $3.28

EVENCARE G3 Meter MPH3540 1/ea N/A

Lab Lead Form

Placement Agreement

Medline EVENCARE G3

EVENCARE G3 Control Solution MPH3560Z 1/bx 19.8.54.34.07

HbA1c and Glucose

QUICK. ACCURATE. EASY-TO-USE.

Lipid Profile

Medline POC

The EVENCARE G3 Blood Glucose Monitoring System from Medline is designed to meet the unique needs of healthcare facilities and their patients. When used as directed, it’s cleared for multiple patient use.

Influenza A & B / RSV

Strep

QC lock mode ensures quality control testing is performed.

Additional POC

Test strip ejector used with single-use lancing device helps reduce cross-contamination.

Urinalysis Hematology

Meter disinfection validated with four common, EPA-registered wipes.*

Chemistry

Immunoassay Item No.

Description

Pkg

MPH3540

Glucose Meter

1 each

MPH3550

Test Strips

50 ea/bx, 12 bx/cs

MPH3550Z

Test Strips

50 ea/bx

MPH3550FL

Foil-wrapped Test Strips

50 ea/bx, 12 bx/cs

MPH3550FLZ

Foil-wrapped Test Strips

50 ea/bx

» No coding required

MPH3560

Control Solution High/Low

6 bx/cs

» 0.8 µl sample size

MPH3560Z

Control Solution High/Low

1 bx

» Results in 6 seconds

MPHBKECR2032

Replacement Battery, 3V

6 ea/bx

» Individually wrapped test strips available

Specialty » Test strips eject without contact

ESR Blood Gas

Contact your Medline representative to request a product trial.

* Ask your Medline representative for product specifics, including EPA registration numbers.

Coagulation

Medline Industries, Inc. Three Lakes Drive, Northfield, IL 60093 Medline United States 1-800-MEDLINE (633-5463)

medline.com | info@medline.com

Medline Canada 1-800-396-6996

medline.ca | canada@medline.com

FOLLOW US

Medline México 01-800-831-0898

medlinemexico.com | mexico@medline.com

Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this brochure. © 2016 Medline Industries, Inc. Medline and EVENCARE are registered trademarks of Medline Industries, Inc. MKT1677932 / LIT1020R / 2.5M / SG / 4

Cardiac BLOG

LIS/Resources Forms


Lab Portfolio Medline EVENCARE G2

EVENCARE G2 Test Strips MPH1550Z 50 ea/bx 19.0.24.7.6 82962 $3.28

EVENCARE G2 Meter MPH1540 1/ea N/A

Placement Agreement

EVENCARE G2 Control Solution MPH1560Z 1/bx 19.7.52.5.63

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas

SIMPLIFIED DIABETES MANAGEMENT.

Coagulation

Cardiac LIS/Resources

EVENCARE G2™ ®

Blood Glucose Monitoring System

Forms


Lab Portfolio

EVENCARE G2 Meter MPH1540 1/ea N/A

EVENCARE G2 Test Strips MPH1550Z 50 ea/bx 19.0.24.7.6 82962 $3.28

Lab Lead Form

Placement Agreement

Medline EVENCARE G2

EVENCARE G2 Control Solution MPH1560Z 1/bx 19.7.52.5.63

HbA1c and Glucose

EVENCARE G2 ®

Lipid Profile

Blood Glucose Monitoring System with Voice Guidance

Medline POC

with Voice Guidance Advanced technology makes it easier to care for residents with diabetes. Easy-to-use

Voice assistance guides you through the testing process and provides you with your results.

Auto code system

Minimizes errors and inaccurate results.

Fast test time

Results in 6 seconds.

Influenza A & B / RSV

“103 mg/dL”

Strep

Small sample size

Small blood requirement, only 1.0uL, means less discomfort.

Additional POC

Alternate site testing

Option to test on the forearm, palm or fingertips.

Urinalysis

Memory option

Stores 300 results and can provide 7-, 14- and 30-day averaging.

Hematology

Chemistry Item No.

Description

Pkg

MPH1540

Glucose Meter

1 Each

MPH1550

Test Strips

50 ea/bx, 12 bx/cs

MPH1550Z

Test Strips

50 ea/bx

MPH1560

Control Solution High/Low

6 bx/cs

MPH1560Z

Control Solution High/Low

1 bx

MPHBAAAZ

Replacement Battery, AAA

24 ea/bx

Immunoassay

Specialty

ESR Blood Gas Contact your Medline representative to request a product trial.

Coagulation

Medline Industries, Inc. Three Lakes Drive, Northfield, IL 60093 Medline United States 1-800-MEDLINE (633-5463)

medline.com | info@medline.com

Medline Canada 1-800-396-6996

medline.ca | canada@medline.com

FOLLOW US

Medline México 01-800-831-0898

medlinemexico.com | mexico@medline.com

Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this brochure. © 2017 Medline Industries, Inc. G2 is a trademark of Medline Industries, Inc.. Medline and EVENCARE are registered trademarks of Medline Industries, Inc. MKT1781543/ LIT818 / 2.5M / SG / 4

Cardiac BLOG

LIS/Resources Forms


Lab Portfolio Lab Lead Form

ADAMS A1c

HbA1c and Glucose

Lipid Profile

Specifications

Medline POC

General Analyzer Type Measurement Items Measurement Principle Guaranteed Measurement Range Measurement Wavelength Sample Type Sample Consumption Required Sample Volume Throughput Processing Speed Sample Loading Capacity Sample Rack Capacity Memory Communication Dimensions Weight Power Supply Measurement Environment Barcode Specifications

Fully automated HbA1C analyzer HbA1C (stable HbA1C, S-A1C) HbF Ion-exchange High Performance Liquid Chromatography

Influenza A & B / RSV

HbA1C: 4 – 15% (20 – 140 mmol/mol) HbF: 0.3 – 5% 420 nm / 500 nm (Dual-wavelength colorimetry) Whole blood collected in K 2-EDTA or K3-EDTA tubes or hemolysate Approximately 14 µL (whole blood) Sample tube: 10 mm from bottom of tube Sample cup: 400 µL 37 tests/hour 90 seconds/test One-way transportation: 50 samples Loop transportation: 100 samples 10 samples/rack 900 results (including calibration results) RS-232 (Bi-directional) or Ethernet 21" (W) x 21" (D) x 21" (H) Analyzer: 86 lbs. Sampler: 9 lbs. 100-240V, 50/60 Hz Temperature: 10 – 30ºC Humidity: 20 – 80% RH (no condensation) CODE 39, NW-7, ITF, CODE 128

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Minneapolis, MN 55439 • 877.538.8872 • corelab@arkrayusa.com • www.arkrayusa.com

AD002-02 Rev 05/18

Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

Lipid Profile Alere Cholestech LDX

PTS Cardiochek

Lipid Profile

Medline POC Influenza A & B / RSV

Abbott Point of Care Piccolo Xpress POINT OF CARE

REAL-TIME CHEMISTRY. REAL-WORLD BENEFITS. • Optimize efficiency and productivity with fast, accurate, on-site testing • Make decisions with confidence with lab-accurate results • Maintain compliance with automated quality control features

Fast, Accurate Lipid and Glucose Results at the Point of Care

• Increase patient satisfaction by reducing the need for call-backs

Strep

• Meet a range of testing needs with a single, versatile platform

Recognizing the strong connection between heart attack, stroke, and diabetes, the CardioChek® Plus analyzer provides rapid on-site blood chemistry values and measurements to help identify at-risk BROAD CLINICAL APPLICATIONS. individuals. It’s one of the fastest, most cost-efficient, and user-friendly analyzers. The CardioChek Plus Piccolo Xpress® meets a wide range of clinical testing needs across a variety of healthcare system accurately tests lipid profile and glucose simultaneously with one fingerstick. In as little as settings and specialties. 90 seconds, it provides on-site results using the same technology as clinical laboratories. • Urgent Care • Primary/Family Care • Pediatrics • Internal Medicine • Cardiology • Hospital Clinics

Measures:

• Triglycerides

Handheld, battery-operated

• Glucose

Patient-Friendly

Calculates:

Wireless Communication

• LDL/HDL Ratio

Easy data transfer

• Non-HDL Cholesterol

High ROI Fully reimbursable

of lipid profile and glucose

Scan this code to see the Piccolo Xpress in action.

To learn more about how the Piccolo Xpress can transform your practice, contact your Abbott Point of Care Representative, or visit www.abbottpointofcare.com Certified Accuracy CLIA-waived

surveys consistently show that many patients

For in vitro diagnostic use only © Abbott Point of Care Inc. 046406 Rev. A 07/16. Piccolo Xpress®, Piccolo® and iQC® are registered trademarks of Abaxis, Inc. Abaxis Part Number 888-3293 Rev. A.

Meets NCEP guidelines for accuracy and precision

— especially those most at risk — are not

CHOOSE TRANSFORMATION™FCC and ISO certified wireless communications

adequately treated.

3-5

See Inspiration in Action at abbottpointofcare.com

ptsdiagnostics.com

• Accuracy you can trust—Lab-accurate results enable clinicians to make decisions with confidence • Maintain control and compliance—Automated quality control checks on every test • Easy to use—Fully automated system makes testing fast and simple for staff • Flexible connectivity—Capable of bi-directional interfacing

MPREHE CO

N

E

therapy for primary and secondary prevention of cardiovascular disease CVD. Yet national

Simultaneous testing

• Test results in minutes—Clinicians have results during a patient visit, accelerating treatment decisions and avoiding call-backs and follow-up visits

M

not had their lipids tested in the last five years.3

VE SI N

Rapid throughput and low waste, with minimal start-up cost

disease (CVD) prevention and management. Over one-third of Americans with high cholesterol have

TRANSFORM YOUR EFFICIENCY WHILE MAINTAINING QUALITY AND COMPLIANCE.

MOS T

• TC/HDL Ratio

Give your patients an advantage in cardiovascular

The latest clinical trials show a benefit of intensive

Additional POC

LAB-ACCURATE TESTING WITHOUT THE WAITING.

Fingerstick with small sample

• LDL Cholesterol

E

TM

•Fast Ambulatory Surgery

Compact and lightweight, easy to transport and store

U

B

L

COMPLETE LIPID PROFILE AS RECOMMENDED BY THE CLINICAL PRACTICE GUIDELINES 1, 2

CHOLESTECH LDX SYSTEM

• Long-Term Care

• Oncology • Dermatology On-site lipid and glucose results in as little as 90 seconds

Portable

• Total Cholesterol • HDL Cholesterol

AVA I L A

Urinalysis

To place your order, call +1 (317) 870-5610.

Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Alere Cholestech Lipid Profile CHLS10989 | 10 ea/bx L20.9.77.3.90 80061QW $13.39

Placement Agreement

Alere Cholestech LDX

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology COMPLETE LIPID PROFILE AS RECOMMENDED BY THE CLINICAL PRACTICE GUIDELINES 1, 2

CHOLESTECH LDX SYSTEM TM

Give your patients an advantage in cardiovascular disease (CVD) prevention and management. Over

Chemistry

Immunoassay

Specialty

ESR

one-third of Americans with high cholesterol have not had their lipids tested in the last five years.3

Blood Gas

The latest clinical trials show a benefit of intensive therapy for primary and secondary prevention of cardiovascular disease CVD. Yet national

Coagulation

surveys consistently show that many patients — especially those most at risk — are not

Cardiac

adequately treated.

3-5

LIS/Resources Forms


Lab Portfolio

Alere Cholestech Lipid Profile CHLS10989 | 10 ea/bx L20.9.77.3.90 80061QW $13.39

Lab Lead Form

Placement Agreement

Alere Cholestech LDX

The Cholestech LDX System for a complete lipid profile TM

BENEFITS AT A GLANCE nn nn

nn nn nn nn nn

CLIA-waived – no special training required Rapid results (just 5 minutes) – enables face-to-face counseling with patients Fingerstick sampling – less painful and time consuming Reimbursed by Medicare and most private payers Small sample size (40 μL) – easy to obtain Highly accurate results Improved office efficiencies – eliminates costly call backs to labs and patients

CONFIDENCE IN RESULTS nn

nn

The Cholestech LDX System’s accuracy and reproducibility has been certified by the lipid testing accuracy standards — the CDC’s LSP and CRMLN programs* (the lipid testing accuracy standards) Used in thousands of physician offices, hospitals and employee wellness programs nationwide

AVAILABLE TESTS LIPID PROFILE · GLU LIPID PROFILE TC · HDL · GLU TC · HDL TC · GLU TC * The Lipid Standardization Program (LSP) certifies that laboratories are traceable to the CDC for total & HDL cholesterol and triglycerides; the Cholesterol Reference Method Laboratory Network (CRMLN) certifies manufacturers of clinical diagnostic products that measure total and HDL cholesterol.

TEST PER GUIDELINES 1,2 IN OFFICE nn

nn

nn

Test fasting lipid profile: total cholesterol (TC), HDL & LDL cholesterol, and triglycerides (TRG) for risk assessment and lipid management Determine anticipated treatment response and assess adherence Demonstrated improvements related to adherence, therapeutic management, measures of atherosclerotic burden and patient satisfacation6-11

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

PRODUCT INFORMATION CATEGORY

PRODUCT

CPT CODE †

10-959

Cholestech LDX System

10-991

Lipid Profile · GLU

80061 QW, 82947 QW

10-989

Lipid Profile

80061 QW

10-990

TC · HDL · GLU

882465 QW, 83718 QW, 82947 QW

10-987

TC · HDL

82465 QW, 83718 QW

10-988

TC · GLU

82465 QW, 82947 QW

10-986

TC

82465 QW

88769

Multianalyte Control Levels 1 and 2 (2 vials Level 1 & 2 vials Level 2, 2 mL each)

88773

Multianalyte Control Levels 1 and 2 (1 vial Level 1 & 1 vial Level 2, 0.25 mL each)

† CPT codes provided are intended as general guidelines only. Abbott and its distributors do not guarantee product coverage or reimbursement accuracy and appropriate usage of codes.

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas 1. Stone NJ et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014; 129:S1-S45. 2. Goff DC et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014; 129:S49-S73. 3. Christian JB et al. Cholesterol screening in US adults and awareness of high cholesterol among individuals with severe hypertriglyceridemia: National Health and Nutrition Examination Surveys 2001- 2008. J Cardiovasc Nurs. 2015; 30:26-34. 4. Muntner P et al. Trends in the prevalence, awareness, treatment and control of high low density lipoprotein-cholesterol among United States adults from 1999-2000 through 2009-2010. Am J Cardiol. 2013; 112:664-70. 5. Jones PH et al. Prevalence of dyslipidemia and lipid goal attainment in statin-treated subjects from 3 data sources: a retrospective analysis. J Am Heart Assoc. 2012; 1:e001800. 6. Haskell WL et al. Multifactor cardiovascular disease risk reduction in medically underserved, high-risk patients. Am J Cardiol 2006; 98:1472-9. 7. Howard BV et al. Effect of lower targets for blood pressure and LDL cholesterol on atherosclerosis in diabetes: the SANDS randomized trial. JAMA 2008; 299:1678-89. 8. Bluml BM et alJ. Pharmaceutical care services and results in Project ImPACT: Hyperlipidemia. J Am Pharm Assoc (Wash) 2000; 40:157-65. 9. Tsuyuki RT et al. Effect of community pharmacist intervention on cholesterol levels in patients at high risk of cardiovascular events: the Second Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP-plus). Am J Med 2004; 116:130-3. 10. Gialamas A et al. Does point-of-care testing lead to the same or better adherence to medication? A randomised controlled trial: the PoCT in General Practice Trial. Med J Aust. 2009; 191:487-91. 11. Laurence CO et al. Patient satisfaction with point-of-care testing in general practice. Br J Gen Pract. 2010; 60:e98-104. © 2019 Abbott. All Rights Reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. Any photos displayed are for illustrative purposes only. Any person depicted in such photos is a model. CVD256543 1000157-09 07/19

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

PTS Cardiochek Lipid Panel PTH1710 | 15/bx 20.11.93.20.08 80061QW $13.39

Lab Lead Form

PTS Cardiochek

HbA1c and Glucose

Lipid Profile

Medline POC

Fast, Accurate Lipid and Glucose Results at the Point of Care

Influenza A & B / RSV

Recognizing the strong connection between heart attack, stroke, and diabetes, the CardioChek® Plus analyzer provides rapid on-site blood chemistry values and measurements to help identify at-risk individuals. It’s one of the fastest, most cost-efficient, and user-friendly analyzers. The CardioChek Plus system accurately tests lipid profile and glucose simultaneously with one fingerstick. In as little as 90 seconds, it provides on-site results using the same technology as clinical laboratories.

Strep

Additional POC

Fast On-site lipid and glucose results in as little as 90 seconds Measures: • Total Cholesterol • HDL Cholesterol • Triglycerides • Glucose Calculates: • LDL Cholesterol • TC/HDL Ratio • LDL/HDL Ratio • Non-HDL Cholesterol

Portable

Hematology

Compact and lightweight, easy to transport and store Handheld, battery-operated

Patient-Friendly Fingerstick with small sample

Wireless Communication Easy data transfer

High ROI Rapid throughput and low waste, with minimal start-up cost Fully reimbursable

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Simultaneous testing of lipid profile and glucose

Urinalysis

Certified Accuracy CLIA-waived Meets NCEP guidelines for accuracy and precision

Cardiac

FCC and ISO certified wireless communications

LIS/Resources ptsdiagnostics.com

To place your order, call +1 (317) 870-5610.

Forms


Lab Portfolio

PTS Cardiochek Lipid Panel PTH1710 | 15/bx 20.11.93.20.08 80061QW $13.39

Lab Lead Form

PTS Cardiochek

HbA1c and Glucose

Wide Variety of Test Strips Provides Medical Professionals Flexibility

Lipid Profile

Three-Analyte

The CardioChek Plus Lipid+eGLU™ SmartBundle™ includes: (3) 15-count Lipid Panel and (1) 50-count eGLU (electrochemical glucose) test strip vials.

Medline POC Influenza A & B / RSV

Lipid Panel Test Strip

Measures: Total Cholesterol, HDL Cholesterol & Triglycerides Calculates: LDL Cholesterol, Total Cholesterol/HDL Ratio, Non-HDL Cholesterol

Strep

CHOL+HDL+GLU Panel Test Strip

Measures: Total Cholesterol, HDL Cholesterol & Glucose Calculates: Total Cholesterol/HDL Cholesterol Ratio

Additional POC

METABOLIC CHEMISTRY Panel Test Strip Measures: HDL Cholesterol, Triglycerides & Glucose

Single-Analyte

Dual-Analyte

Urinalysis CHOL+GLU Panel Test Strip

Hematology

Measures: Total Cholesterol & Glucose

CHOL+HDL Panel Test Strip

Measures: Total Cholesterol & HDL Cholesterol Calculates: Total Cholesterol/HDL Cholesterol Ratio

Chemistry

TOTAL CHOLESTEROL Test Strip

Immunoassay

Measures: Total Cholesterol

HDL CHOLESTEROL Test Strip

Specialty

Measures: HDL Cholesterol

TRIGLYCERIDES Test Strip

ESR

Measures: Triglycerides

GLUCOSE Test Strip

Measures: Glucose

Blood Gas

eGLU Test Strip

Measures: Electrochemical Glucose

Coagulation

Single-analyte test strips available as special order include Creatinine and Ketone.

PTS Diagnostics 7736 Zionsville Road, Indianapolis, IN 46268 USA Office: +1 (317) 870.5610 FAX: +1 (317) 870.5608 Toll-Free in the U.S. : +1 (877) 870.5608

Cardiac LIS/Resources

ptsdiagnostics.com CardioChek, PTS Panels, eGLU, and SmartBundle are trademarks of Polymer Technology Systems, Inc. © 2014 PTS, Inc. MKG-001095 EN Rev. 0 11/14

Forms


Lab Portfolio Abbott POC Piccolo Xpress

Placement Agreement

Lab Lead Form HbA1c and Glucose POINT OF CARE Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology

LAB-ACCURATE TESTING WITHOUT THE WAITING.

Chemistry

Immunoassay

• Flexible connectivity—Capable of bi-directional interfacing

Blood Gas

E

N

E

• Easy to use—Fully automated system makes testing fast and simple for staff

M

• Maintain control and compliance—Automated quality control checks on every test

ESR

MPREHE CO

U

B

L

• Accuracy you can trust—Lab-accurate results enable clinicians to make decisions with confidence

Specialty

VE SI N

• Test results in minutes—Clinicians have results during a patient visit, accelerating treatment decisions and avoiding call-backs and follow-up visits

MOS T

TRANSFORM YOUR EFFICIENCY WHILE MAINTAINING QUALITY AND COMPLIANCE.

AVA I L A

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Placement Agreement

Abbott POC Piccolo Xpress

Lab Lead Form

ACCELERATE TESTING. ASSURE COMPLIANCE. • Accuracy and precision comparable to larger laboratory analyzers • iQC® system performs continuous quality control checks on every run, helping maintain compliance while eliminating daily control testing requirements • Fully automated system—minimal testing experience required • Small blood sample—just 100 μL of whole blood, serum, or plasma

A 2014 study in the American Journal of Clinical Pathology1 found that point-of-care testing significantly improved clinical operations, resulting in: • 21% reduction in tests ordered • 89% reduction in follow-up phone calls • 85% reduction in follow-up letters • 61% reduction in follow-up visits • Practice efficiency cost savings totaling $24.64/patient2

HbA1c and Glucose

FROM SAM

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Step 1: Add sample Additional POC

MONITOR A RANGE OF PARAMETERS WITH ONE, EASYBUN Ca CICRE GLU

07P02-04

Lipid Panel

Lipid Panel Plus

Liver Panel Plus

CHOL CHOL/HDL* nHDLc* HDL LDL* TRIG VLDL*

ALT AST CHOL CHOL/ HDL*

07P02-05

07P02-12

07P02-10

General Chemistry 6

General Chemistry 13

Electrolyte Panel

GGT GLU eGFR*

TS

IN

UTE R

UL

E AVA I L A

ALT AST BUN CRE

B

L

E

U

12-M

M

N

VE SI N

MOS T

Basic Metabolic Panel

GLU ALB K+ ALP Na+ ALT TBIL AST tCO2 BUN Ca TP CIeGFR* CRE 07P02-08

ES

ALB ALP ALT AMY AST BUN Ca

nHDLc* GLU HDL LDL* TRIG VLDL*

CRE GGT GLU TBIL TP UA eGFR*

ALB ALP ALT AMY

K+ Na+ tCO2 eGFR*

AST GGT TBIL TP

ClK+ Na+ tCO2

07P02-02

Kidney Check

Renal Function Panel

MetLyte 8 Panel

BUN CRE eGFR*

ALB BUN Ca ClCRE GLU

BUN CK ClCRE GLU

07P02-07

IN

Chemistry MetLyte Plus CRP

K+ BUN Immunoassay CK ClCRE GLU

Na+ tCO2 CRP eGFR*

07P02-14

ESR Blood Gas

07P02-11

07P02-09

Complex Panels

Specialty

07P02-01

K+ Na+ PHOS tCO2 eGFR*

Hematology Moderately

12-M

Comprehensive Metabolic Panel

MPREHE CO

Urinalysis

K+ Na+ tCO2 eGFR*

07P02-03

Coagulation Cardiac

*Calculated. Note: Each panel comes LIS/Resources 1. Crocker, J et al, Implementation of P Am J Clin Pathol November 2014;142

Forms


Lab Portfolio Placement Agreement

Abbott POC Piccolo Xpress

Lab Lead Form HbA1c and Glucose

FROM SAMPLE TO RESULT IN 3 SIMPLE STEPS

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Step 1: Add sample

Step 2: Insert rotor

Step 3: Read results Additional POC

ONE, EASY-TO-USE PLATFORM Hepatic Function Panel

MetLyte Plus CRP BUN CK ClCRE GLU

K+ Na+ tCO2 CRP eGFR*

07P02-14

TS

IN

DBIL TBIL TP

UL

12-M

Moderately Complex Panels

ALB ALP ALT AST

UTE RES

Basic Metabolic Panel Plus K+ BUN Na+ Ca tCO2 CICRE Mg GLU eGFR* Lactate Dehydrogenase

07P02-06

07P02-13

Biochemistry Panel Plus

MetLac 12 Panel

ALB ALP ALT AMY AST BUN Ca

CRE CRP GGT GLU TP UA eGFR*

07P02-15

ALB BUN Ca ClCRE GLU

LAC K+ Mg Na+ PHOS

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

07P02-16

ESR Blood Gas

Coagulation Cardiac

*Calculated. Note: Each panel comes in a package of 10. 1. Crocker, J et al, Implementation of Point-of-Care Testing in an Ambulatory Practice of an Academic Medical Center, Am J Clin Pathol November 2014;142:640-646 2. Actual savings can vary depending on state-specific factors.

LIS/Resources Forms


Lab Portfolio Placement Agreement

Abbott POC Piccolo Xpress

Lab Lead Form HbA1c and Glucose

REAL-TIME CHEMISTRY. REAL-WORLD BENEFITS. • Optimize efficiency and productivity with fast, accurate, on-site testing • Make decisions with confidence with lab-accurate results • Maintain compliance with automated quality control features

Lipid Profile Profile Lipid Medline POC

• Increase patient satisfaction by reducing the need for call-backs • Meet a range of testing needs with a single, versatile platform

BROAD CLINICAL APPLICATIONS.

Influenza A & B / RSV

Strep

Piccolo Xpress meets a wide range of clinical testing needs across a variety of healthcare settings and specialties. ®

• Urgent Care

• Primary/Family Care

• Pediatrics

• Internal Medicine

• Long-Term Care

• Ambulatory Surgery

• Cardiology

• Oncology

• Dermatology

• Hospital Clinics

Additional POC Urinalysis

Hematology

LAB-A WITHO

Chemistry

Immunoassay

Specialty

ESR Blood Gas

Scan this code to see the Piccolo Xpress in action.

To learn more about how the Piccolo Xpress can transform your practice, contact your Abbott Point of Care Representative, or visit www.abbottpointofcare.com

Coagulation Cardiac

For in vitro diagnostic use only © Abbott Point of Care Inc. 046406 Rev. A 07/16. Piccolo Xpress , Piccolo and iQC are registered trademarks of Abaxis, Inc. Abaxis Part Number 888-3293 Rev. A. ®

CHOOSE TRANSFORMATION™ See Inspiration in Action at abbottpointofcare.com

®

®

LIS/Resources Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

Medline POC Medline hCG Pregnancy Tests

Medline Point of Care

Lipid Profile

Medline POC

Medline Strep A Cassette

Medline Mono Cassette

Group A Strep Test

Influenza A & B / RSV

Strep

Point-of-Care testing accelerates care. Fast results. Immediate care. The Medline Strep A Test provides a high-performance, easy-to-use Strep A test for use in CLIA-waived labs. This highly sensitive test qualitatively detects the presence of Strep A antigen in a throat swab, delivering rapid results.

WHEN YOU NEED FAST, ACCURATE RESULTS. Pregnancy (hCG) Test

RAPID RESULTS. BETTER CARE.

Features of the Strep A Test • Results in 5 minutes

• 1 minute hands-on time • Simple and accurate • Reimbursable

Benefits of Rapid Diagnosis1 • Helps avoid unnecessary antibiotic use • Empowers timely treatment decisions

Mono Test Cassette

Point-of-Care Testing Accelerates Care 1

RAPID RESULTS FOR RAPID CARE.

Additional POC

• Guides appropriate therapy

Point-of-Care Testing Accelerates Care 1

Performance 100 80

97.0%

95.0%

95.0%

Sensitivity

Specificity

Overall Accuracy

60 40

Urinalysis

20 0

CLIA Waived Point-of-Care Tests

Empowering clinicians to make decisions at the point-of-care.

Hematology Medline H. pylori Test

Medline Urinalysis Tests

Medline iFOB Test Kits

Chemistry

CRITICAL SCREENING MADE FAST AND EASY.

10 MINUTES TO BETTER HEALTH.

Immunoassay

Simple, non-invasive and effective.

H. pylori Test

Point-of-Care Testing Accelerates Care

SPEND MORE QUALITY TIME WITH YOUR PATIENTS.

Immunochemical Fecal Occult Blood Test (iFOBT)

Patient-friendly test. Accurate results. Excellent value.

Specialty

Medline 120 Mini Urine Analyzer & Urinalysis Strips Quick, Reliable Results at the Point-of-Care

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Medline Point of Care

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

RAPID RESULTS FOR RAPID CARE.

ESR Blood Gas Coagulation

Cardiac LIS/Resources

CLIA Waived Point-of-Care Tests

Empowering clinicians to make decisions at the point-of-care.

Forms


Lab Portfolio Lab Lead Form

Medline Point of Care

HbA1c and Glucose

Lipid Profile

TEST AT THE POINT-OF-CARE FOR ENHANCED QUALITY OF CARE. The emphasis of care is shifting toward prevention and early detection of disease, as well as management of multiple chronic conditions.1 Point-of-care testing gives immediate results in non-laboratory settings to support a more patient-centered approach to healthcare delivery.1 Medline point-of-care tests provide the accurate, rapid results necessary to evaluate and deliver value-based care and a better patient experience. Our point-of-care tests can also help improve staff efficiencies and enhance patient satisfaction, which may result in increased referrals and revenue.

Get the Right Results, Right Now.

Improve Compliance Through Convenience.

Multiply Your Savings With One-Stop Shopping.

Fast and accurate, Medline point-ofcare tests allow you to test and review results during the patient visit. Staff no longer spends extra time tracking down labs and leaving messages. And patients get immediate care.

When patients don’t have to schedule a second appointment and take additional time away from work or other activities, they’re more likely to follow through with needed tests. In addition, they can receive results and a treatment plan all in one visit.

With our full portfolio of pointof-care tests, Medline can help save you time and money through consolidated ordering. Instead of working with several vendors, you can now have one trusted point of contact, resulting in preferred pricing, less paperwork and streamlined ordering, invoicing and delivery.

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Medline Point of Care

HbA1c and Glucose

Influenza A & B Test

Lipid Profile

The Medline Influenza Test is a simple, rapid test that aids in the differential diagnosis of influenza A & B using nasal swab specimens. The easy-to-use format and rapid results allow for quick diagnosis and timely treatment.

Medline POC

Rapid results for immediate treatment.

Advantages » Results in 10 minutes

Influenza A & B / RSV

» Sensitivity*: Flu A: 93.8% | Flu B: 77.4% » Specificity*: Flu A: 95.8% | Flu B: 98.0% » CLIA waived Item No. Description MPH60025FLU Medline Influenza A & B Test Strips

Strep

Pkg. 25 ea/bx

Additional POC

Strep A Test

Quality results in five minutes. Medline Strep A Test Strips provide the rapid, qualitative detection of Strep A antigen using a throat swab. This allows for accelerated patient and resident care.

Advantages

Urinalysis Hematology

» Results in 5 minutes » Sensitivity*: 97%

Chemistry

» Specificity*: 95% » CLIA waived Item No. MPH30025SA

Description Medline Strep A Test Strips

Pkg. 25 ea/bx

Immunoassay

Specialty

iFOB Test

Fast and easy screening for GI disorders and colorectal cancer. Simple and fast, this patient-friendly test is non-invasive, requires only one sample per test, and provides high sensitivity and specificity.

Advantages

ESR Blood Gas

» Results in 5 minutes » Specific for human hemoglobin protein » 50ng hHB/mL analytical sensitivity*

Coagulation

» 99.7% relative accuracy* » CLIA waived Item No. MPH70025CTM MPH70025CT MPH70025M MPH70025T

Description iFOB Test Kit: Test Cassettes, Collection Tubes and Mailers iFOB Test Kit: Test Cassettes and Collection Tubes iFOB Mailers iFOB Collection Tubes

Pkg. 25 ea/bx 25 ea/bx 25 ea/bx 25 ea/bx

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Medline Point of Care

HbA1c and Glucose

Pregnancy Tests

Lipid Profile

For when you need fast, accurate results. Medline provides a range of highly accurate, rapid tests that detect human chorionic gonadotropin (hCG) in urine or urine/serum for early detection of pregnancy.

Medline POC

Advantages » Results in 3 minutes (5 minutes for serum); positive may become visible sooner » Greater than 99% sensitivity » hCG detection*: – Urine strip and cassette tests detect 25 mlU/ml – Combo+ test detects 20 mlU/ml for urine and 10 mlU/ml for serum » CLIA complexity: – Waived using urine – Moderate complexity using serum Item No. MPH22025HCG MPH12025HCG MPH11025HCG

Description Medline hCG Pregnancy Combo+ Test Cassette Medline hCG Pregnancy Test Cassette Medline hCG Pregnancy Test Strip

Pkg. 25 ea/bx 25 ea/bx 25 ea/bx

Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Mono Test

Eight minutes to better health. The Medline Mono Test Cassette provides exceptional performance for the diagnosis of mononucleosis. The simple procedure delivers rapid results during the patient visit, enabling you to deliver immediate therapy.

Advantages » Sensitivity: >99.9%; Specificity: 98.8%

» Fingerstick whole blood capability facilitates easy screening

» No age limitations

» CLIA complexity: – Waived using whole blood » Detects IgM antibodies to – Moderate complexity using distinguish between active and past infections serum or plasma Item No. MPH50025M

Description Medline Mono Test Cassette

Pkg. 25 ea/bx

Hematology

Chemistry

Immunoassay

Specialty

ESR

H. pylori Test

Accurate results in ten minutes. The Medline H. pylori Test Cassette provides patented, innovative technology. The easy, two-step point-of-care test delivers direct detection of H. pylori antibodies for immediate results.

Blood Gas Coagulation

Advantages » Provides physicians with fast results for early diagnosis

» Reduces the risk of developing more serious illnesses

» Allows patient to start therapy sooner

» Reduces the likelihood of complications

Item No.

Description

Pkg.

MPH40020HP

Medline H. pylori Test

20 ea/bx

Cardiac LIS/Resources

*Refer to Instructions for Use.

Forms


Lab Portfolio Lab Lead Form

Medline Point of Care

HbA1c and Glucose

Medline 120 Mini Urine Analyzer

Lipid Profile

A quick, convenient way to detect multiple analytes at the point-of-care.

Medline POC

The Medline 120 Mini Urine Analyzer is specifically designed to improve accuracy and efficiency, allowing you and your staff to spend less time testing and more time with patients. Analyzer reading also helps standardize patient care.

Influenza A & B / RSV

Advantages » Automatic calibration for accurate results and easy operation » Reads Medline Urinalysis ALB/CRE, 4OB, 5OB, URO7 and 10SG parameter strips

Strep

» Saves and recalls the last 2,000 results » Optional barcode reader

Additional POC

» User and QC lockout Item No.

Description

Pkg.

MPHUA120MP

Medline 120 Mini Urine Analyzer Promo (includes analyzer and 5 bottles of 10SG strips)

1/kt

Urinalysis

Medline Urinalysis Reagent Strips

Hematology

Accurate results quickly.

The easy-to-read strips provide fast, qualitative results, aiding in the preliminary diagnosis and screening of many potential health issues.

Chemistry

Advantages » Multiple strip configurations to fit your testing needs » Compatible for visual and analyzer reading

Immunoassay

» Analytes appear in the same order as leading brands » CLIA waived Item No. MPHUA10SG MPHUAURO7 MPHUA5OB MPHUA4OB MPHUA2GP MPHUAMAC

Description Medline 10SG Urinalysis Strips Medline URO7 Urinalysis Strips Medline 5OB Urinalysis Strips Medline 4OB Urinalysis Strips Medline 2GP Urinalysis Strips (visual read only) Medline ALB/CRE Urinalysis Strip

Pkg. 100 ea/bt 100 ea/bt 100 ea/bt 100 ea/bt 100 ea/bt 100 ea/bt

Specialty

ESR Blood Gas

Analytes Item No. MPHUA10SG MPHUAURO7 MPHUA5OB MPHUA4OB MPHUA2GP MPHUAMAC

Leukocytes

• • • •

Nitrite Urobilinogen Protein

• • • •

• • • • •

pH

• •

Blood

• • •

Specific Gravity

Ketone

• •

Bilirubin

Glucose

• • • • •

Albumin Creatinine

Coagulation

Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Medline Point of Care

HbA1c and Glucose

ADVANCING THE HEALTH OF™ HEALTHCARE.

Lipid Profile

Medline POC Influenza A & B / RSV

Just like patients, healthcare providers are looking for ways to stay healthy. Medline exists to help our customers strengthen their clinical and financial health. Privately held and 100 percent debt free, we have the freedom and flexibility to provide a broad array of rapid, point-of-care tests and other diagnostic products to help diagnose, treat and monitor your patients quickly and efficiently. Plus, because we manufacture many of our products, we can offer you significant savings and assured quality and availability.

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Contact your Medline Representative or call 1-800-MEDLINE to order your tests today.

Blood Gas Coagulation

Medline Industries, Inc. Three Lakes Drive, Northfield, IL 60093 Medline United States 1-800-MEDLINE (633-5463)

medline.com | info@medline.com

Medline Canada 1-800-396-6996

medline.ca | canada@medline.com

FOLLOW US

BLOG

Medline México 01-800-831-0898

Cardiac

medlinemexico.com | mexico@medline.com

Reference: 1. Point-of-Care Diagnostic Testing. National Institutes of Health. Available at: http://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=112 Accessed September 1, 2015.

LIS/Resources

Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this brochure. © 2017 Medline Industries, Inc. Medline is a registered trademark of Medline Industries, Inc. MKT1791695 / LIT494 / 2.5M / SG / 3

Forms


Lab Portfolio

Medline hCG Pregnancy Strips MPH11025HCG 25 ea/bx 20.0.71.33.24 81025QW $8.61

Medline hCG Pregnancy Cassette MPH12025HCG 25 ea/bx 20.1.24.80 81025QW $8.61

Medline hCG Pregnancy Combo Cassette MPH22025HCG | 25 ea/ bx 20.1.12.24.18 81025QW $8.61

Lab Lead Form

Medline Pregnancy (hCG)

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

WHEN YOU NEED FAST, ACCURATE RESULTS. Pregnancy (hCG) Test

Point-of-Care Testing Accelerates Care

Immunoassay

Specialty

ESR Blood Gas

1

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Medline hCG Pregnancy Cassette MPH12025HCG 25 ea/bx 20.1.00.24.80 81025QW $8.61

Medline hCG Pregnancy Strips MPH11025HCG 25 ea/bx 20.0.71.33.24 81025QW $8.61

Medline hCG Pregnancy Combo Cassette MPH22025HCG | 25 ea/ bx 20.1.12.24.18 81025QW $8.61

Lab Lead Form

Medline Pregnancy (hCG)

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

EARLY DETECTION PREGNANCY TEST. WHEN ACCURACY MATTERS MOST. The Medline portfolio of hCG products provides qualitative and highly sensitive tests for human chorionic gonadotropin (hCG) in urine or serum for early detection of pregnancy. The simple, highly accurate procedure delivers rapid results during the patient visit, enabling you to deliver immediate care. Features of the Pregnancy (hCG) Test Our line of hCG tests are available in a variety of options to fit your staff and patient needs. Test formats include: urine dipstick, urine cassette and a urine/serum combination cassette. » Positive results in 3 minutes (5 minutes for serum) » CLIA waived test using urine » Moderate complexity test using serum Benefits » Provides physicians with fast, accurate results for early detection » Reduces staff hands-on time and increases office efficiency » Provides flexibility to meet your testing needs with a variety of options

Strep

ORDERING INFO hCG Urine Pregnancy Strip » CLIA waived » Positive results in 3 minutes » Sensitivity: 25 mIU/ml » CPT Code: 81025/QW Item Number MPH11025HCG

Additional POC

Description Medline Urine Pregnancy Strip

Pkg. 25 ea/bx

Urinalysis

hCG Urine Pregnancy Cassette » CLIA waived » Positive results in 3 minutes » Sensitivity: 25 mIU/ml » CPT Code: 81025/QW Item Number MPH12025HCG

Hematology

Description Medline Urine Pregnancy Cassette

Pkg. 25 ea/bx

Chemistry

hCG Combo Urine/Serum Pregnancy Cassette Urine - CLIA Waived; Serum - Moderately Complex » Positive results: Urine - 3 minutes; Serum - 5 minutes » Sensitivity: Urine - 20 mIU/ml; Serum - 10 mIU/ml » CPT Code: Urine - 81025/QW; Serum - 84703 Item Number MPH22025HCG

Description Medline Pregnancy Combo Cassette

Immunoassay Pkg. 25 ea/bx

Specialty

Contact your Medline representative or call 1-800-MEDLINE to order yours today.

ESR Medline Industries, Inc. One Medline Place, Mundelein, IL 60060 Medline United States 1-800-MEDLINE (633-5463)

medline.com | info@medline.com

Medline Canada 1-800-396-6996

medline.ca | canada@medline.com

FOLLOW US

Medline México 01-800-831-0898

medlinemexico.com | mexico@medline.com

BLOG

Blood Gas

©2015 Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc. MKT1661941 / LIT567R / 2.5M / SG / 33

2

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Medline Strep A Cassette MPH30025SA 25 ea/bx 20.1.22.22.95 87880QW $16.53

Lab Lead Form

Medline Strep A

Group A Strep Test

Point-of-Care testing accelerates care.

HbA1c and Glucose

Lipid Profile

Medline POC

Fast results. Immediate care.

Influenza A & B / RSV

The Medline Strep A Test provides a high-performance, easy-to-use Strep A test for use in CLIA-waived labs. This highly sensitive test qualitatively detects the presence of Strep A antigen in a throat swab, delivering rapid results.

Features of the Strep A Test

Strep

Additional POC

Urinalysis Hematology

• Results in 5 minutes

• 1 minute hands-on time

Chemistry

• Simple and accurate • Reimbursable

Benefits of Rapid Diagnosis1

Immunoassay

• Guides appropriate therapy • Helps avoid unnecessary antibiotic use

Specialty

• Empowers timely treatment decisions

ESR

Performance Blood Gas

100 80

97.0%

95.0%

95.0%

60

Coagulation

40 20 0

Sensitivity

Specificity

Overall Accuracy

Cardiac LIS/Resources Forms


Lab Portfolio

Medline Strep A Cassette MPH30025SA 25 ea/bx 20.1.22.22.95 87880QW $16.53

Lab Lead Form

Medline Strep A

HbA1c and Glucose

Lipid Profile

Strep A Test. Fast results accelerate treatment. Medline POC

Easy to Read

Easy to Use

Influenza A & B / RSV A

B

Positive MAX

1 minute

1 Add four drops each of Reagent A and Reagent B to extraction tube.

2 Place the swab in the tube, rotate 10 times and leave in the tube for one minute.

Test

Control

M

T C

M

T C

Strep

Additional POC

Negative M

T C

Urinalysis

MEDLINE STREP A MEDLINE STREP A

Invalid M

T C

M

T C

Hematology

CC

Chemistry

TT

5 minutes

3 Squeeze the tube around the swab head to expel all the liquid. Remove the swab from the tube.

Medline is the solution for all your point-ofcare needs

4 Insert test strip. Wait 5 minutes and then read the result.

Immunoassay

Specialty

ESR As a leading provider of quality medical supplies, Medline offers a broad array of rapid, point-of-care tests, as well as other diagnostic equipment to help diagnose, treat and monitor your patients quickly and efficiently.

Blood Gas Coagulation

Ordering Information Item No.

Description

Pkg.

MPH30025SA

Medline Strep A Test Strip

25/bx

Cardiac Learn more. Contact your Medline Representative, call 1-800-MEDLINE or visit medline.com. REFERENCE: 1 Sheeler RD, Houston MS, Radke S, et al. Accuracy of Rapid Strep Testing in Patients Who Have Had Recent Streptococcal Pharyngitis. J Am Board Fam Med. 2002;15(4). Available at: http://www.medscape.com/viewarticle/440096_1 Accessed October 8, 2015. © 2020 Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc. MKT19W669948 / LIT561R / 2.5M / SG / 57

LIS/Resources Forms


Lab Portfolio

Medline Mono Cassette MPH50025M 25 ea/bx 20.3.08.20.74 86308QW $5.18

Lab Lead Form

Medline Mono Cassette

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

RAPID RESULTS. BETTER CARE.

Immunoassay

Specialty

ESR

Mono Test Cassette

Blood Gas

Point-of-Care Testing Accelerates Care 1

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Medline Mono Cassette MPH50025M 25 ea/bx 20.3.08.20.74 86308QW $5.18

Lab Lead Form

Medline Mono Cassette

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

PERFORMANCE*

MONO TEST CASSETTE. EIGHT MINUTES TO BETTER HEALTH.

EASY TO READ

Strep

Package Insert Data

100%

Positive

80%

Negative

Invalid

60% 40%

The Medline Mono Test Cassette provides exceptional performance for the diagnosis of Mononucleosis. The simple procedure delivers rapid, highly accurate results during the patient visit, enabling you to deliver immediate care with a test that fits your staffing requirements.

Additional POC

20% 0%

Relative Specifity: 98.8

Relative Sensitivity: >99.9

Overall Agreement: 99

Medline is the solution for all your point-of-care needs

*Agreement with comparative test

EASY TO USE

Dev Sol

1a Align tip of red fill line transfer pipette over Sample Well (S) and squeeze pipette bulb to add 25 µl whole blood. Add 2-3 drops of Developer Solution.

Features of the Mono Test Cassette » No age limitations » Positive results in 8 minutes » Room temperature storage » CLIA Complexity: ·Waived for whole blood ·Moderate complexity for serum or plasma » Detects IgM antibodies to distinguish between active and past infections

Contact your Medline representative or call 1-800-MEDLINE to order yours today.

2

Wait 8 minutes and then read results.

Dev Sol

Item No.: Description: Pkg:

Urinalysis Hematology

Chemistry

ORDERING INFO

OR Align tip of black fill 1b line transfer pipette over Sample Well (S) and squeeze pipette bulb to add 10 µl serum/plasma. Add 2-3 drops of Developer Solution.

Benefits » Allows patients to start therapy sooner » May decrease need for unnecessary, ancillary testing » Reduces staff hands-on time and increases office efficiency » Fingerstick whole blood capability facilitates easy screening » Relative sensitivity at 99.9% for earlier IM detection*

As the healthcare industry’s leading provider of quality medical supplies, Medline offers a broad array of rapid, point-of-care tests, as well as other diagnostic equipment to help diagnose, treat and monitor your patients quickly and efficiently.

MPH50025M Medline Mono Test Cassette 25 ea/bx

Immunoassay

Specialty

8’

ESR Medline Industries, Inc. One Medline Place, Mundelein, IL 60060 Medline United States 1-800-MEDLINE (633-5463)

medline.com | info@medline.com

Medline Canada 1-800-396-6996

medline.ca | canada@medline.com

FOLLOW US

Medline México 01-800-831-0898

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BLOG

Blood Gas

©2015 Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc. MKT1548722 / e15124 / 1M / SG / 33

2

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Medline H. pylori Test

Medline H. Pylori Cassette MPH40020HP 20 ea/bx 20.4.22.23.78 86318QW $18.09

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC

Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

10 MINUTES TO BETTER HEALTH.

Specialty

ESR

H. pylori Test

Point-of-Care Testing Accelerates Care

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Medline H. Pylori Cassette MPH40020HP 20 ea/bx 20.4.22.23.78 86318QW $18.09

Lab Lead Form

Medline H. pylori Test

HbA1c and Glucose

Lipid Profile Medline POC

Influenza A & B / RSV

Strep

H. PYLORI TEST. ACCURATE. FAST RESULTS.

EASY TO USE

EASY TO READ Positive

1a Place 2 drops of

Urinalysis

OR

Features of the H. pylori Test » Two easy steps, with results in 10 minutes » CLIA waived, easy-to-use test » Built-in control ensures accuracy » Use with multiple sample types – whole blood, serum or plasma Benefits » Provides physicians with fast results for early diagnosis » Allows patient to start therapy sooner » Reduces the risk of developing more serious illnesses » Decreases unnecessary use of antibiotics

1b Place 50 μL

Contact your Medline Representative or call 1-800-MEDLINE to order yours today.

50 µL

fingerstick whole blood + 1 drop buffer

1c Place 2 drops of

Serum or Plasma + 1 drop buffer

Wait 10 minutes and then read results

medline.ca | canada@medline.com

Hematology

Chemistry

Immunoassay

ORDERING INFO 10’

Item No.

Description

Medline H. pylori MPH40020HP Test Cassette

Medline Industries, Inc. Three Lakes Drive, Northfield, IL 60093 Medline Canada 1-800-396-6996

Medline is the solution for all your point-of-care needs As the healthcare industry’s leading provider of quality medical supplies, Medline offers a broad array of rapid, point-of-care tests, as well as other diagnostic equipment to help diagnose, treat and monitor your patients quickly and efficiently.

OR

2

medline.com | info@medline.com

Additional POC

Invalid

Venipuncture whole blood + 1 drop buffer

This patented, innovative technology that provides a highly sensitive and specific test for H. pylori. The easy, two-step point-of-care test delivers direct detection of H. pylori antibodies for immediate results.

Medline United States 1-800-MEDLINE (633-5463)

Negative

FOLLOW US

Pkg. 20 ea/bx

BLOG

Specialty

ESR

Medline México 01-800-831-0898

medlinemexico.com | mexico@medline.com

Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this brochure. © 2017 Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc. MKT1792181 / LIT005 / 2.5M / DP / 3

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Medline Urinalysis

Medline Mini Urine Analyzer Bundle MPHUA120MP | 500ea/bundle 20.0.50.NEG

Medline Urinalysis 10SG Strip MPHUA10SG | 100ea/bottle 20.0.25.42.12 81003QW $2.25

Medline Urinalysis Albumin/Creatinine Strip MPHUAMAC | 25 ea/bottle 20.3.00.23.20 82044QW & 82570QW $11.41

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

SPEND MORE QUALITY TIME WITH YOUR PATIENTS.

ESR Blood Gas Coagulation

Cardiac LIS/Resources

Medline 120 Mini Urine Analyzer & Urinalysis Strips Quick, Reliable Results at the Point-of-Care

Forms


Lab Portfolio

Medline Mini Urine Analyzer Bundle MPHUA120MP | 500ea/bundle 20.0.50.NEG

Medline Urinalysis

Medline Urinalysis 10SG Strip MPHUA10SG | 100ea/bottle 20.0.25.42.12 81003QW $2.25

Medline Urinalysis Albumin/Creatinine Strip MPHUAMAC | 25 ea/bottle 20.3.00.23.20 82044QW & 82570QW $11.41

Lab Lead Form HbA1c and Glucose

CLIA WAIVED

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

MEDLINE 120 MINI URINE ANALYZER

A quick, convenient way to detect multiple analytes at point-of-care. The Medline 120 Mini Urine Analyzer is intended for use with the Medline Urinalysis test strips. It is specifically designed to improve accuracy and efficiency, allowing you to spend less time testing and more time with your patients. If your staff is currently reading urinalysis strips manually, switch to the Medline 120 Mini Urine Analyzer to save time and standardize patient care.

Accurate and Easy to Use

» Automatic calibration for accurate results and easy operation » Reads Medline Urinalysis MAC, 4, 5, 7 and 10 parameter strips » Minimal training required

Hematology

Chemistry

Immunoassay

Specialty

ESR

Convenient to Operate

» Processes up to 120 tests/hour in Continuous Test Mode » Saves and recalls the last 2,000 results automatically » Set QC values to obtain Pass/Fail Summary

Easy Data Management

» Includes RS232C and USB ports for easy data transfer* » Manual or optional barcode-enabled patient ID input

Lockout Functions

» Operator lockout for enhanced compliance » QC lockout enhances compliance and standardizes external QC testing *Note: EMR connectivity through middleware is available at an additional cost.

2 MEDLINE

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Medline Mini Urine Analyzer Bundle MPHUA120MP | 500ea/bundle 20.0.50.NEG

Medline Urinalysis 10SG Strip MPHUA10SG | 100ea/bottle 20.0.25.42.12 81003QW $2.25

Medline Urinalysis Albumin/Creatinine Strip MPHUAMAC | 25 ea/bottle 20.3.00.23.20 82044QW & 82570QW $11.41

Lab Lead Form

Medline Urinalysis

HbA1c and Glucose Medline 120 Mini Urine Analyzer Specifications Feature Analyzer Type Methodology Detection Throughput Test Modes Lockout Functions Memory Strip Incubation Time Wavelength of Monochromatic LED Strips Available Analyzer Ports Capabilities Major Readable Barcodes Calibration Available Languages on the Screen Operating Conditions Storage Conditions Power Source Dimensions (L x W x H) Display Dimensions (L x W) Weight

Specification Semi-automatic Reflectance Photometry Photosensitive Diode Single Test Option: 60 tests/hour, Continuous Test Option: 120 tests/hour Routine, STAT, and QC User/QC Lockout Last 2,000 results 1 Minute 525 nm and 635 nm MAC, 4, 5, 7, 10 Parameters Standard RS232C Port for Barcode Reader or Data Transfer, USB Port for Data Transfer, 25 Pin Parallel Port for External Printer Internal Thermal Printer (Included), RS232C Barcode Reader (optional), Optional External Printer (not included), USB or RS232C Data Transfer Cable (optional) Code 128, Code 39, Codeabar (NW-7), Interleaved 25, UPC-A, UPC-E, EAN 8, EAN 13 Automatic English, Spanish, French, Italian, Portuguese 32 - 104˚F (0 - 40˚C); ≤ 85% RH 23-122˚F (-5-50˚C); ≤90% RH 100-240 VAC, 50-60 Hz 27.2 cm x 18 cm x 10.5 cm (10.7" x 7" x 4.1") 11 cm x 6.5 cm (4.3" x 2.6") 4.2 lbs. (1.9 kg)

MEDLINE URINALYSIS REAGENT STRIPS

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR

Get fast, accurate results.

Provide patients with immediate results and assist diagnosis by completing the test in office.

Blood Gas

Accurate

» High quality color chart ensures accurate visual reading » CLIA Waived

Coagulation

Flexible

» Multiple strip configurations to fit your testing needs » Compatible for visual and analyzer reading

Cardiac

Simple

» Analytes appear in the same order as leading brands

LIS/Resources

1-800-MEDLINE (633-5463) | medline.com 3

Forms


Lab Portfolio

Medline Urinalysis 10SG Strip MPHUA10SG | 100ea/bottle 20.0.25.42.12 81003QW $2.25

Medline Mini Urine Analyzer Bundle MPHUA120MP | 500ea/bundle 20.0.50.NEG

Medline Urinalysis Albumin/Creatinine Strip MPHUAMAC | 25 ea/bottle 20.3.00.23.20 82044QW & 82570QW $11.41

Lab Lead Form

Medline Urinalysis

HbA1c and Glucose

Ordering Information

Lipid Profile

Medline 120 Mini Urine Analyzer Item No. MPHUA120MP

Description Medline 120 Mini Urine Analyzer Promo (Includes analyzer and 5 boxes of Medline 10SG urine strips)

Medline POC

Urinalysis Strips

Medline Urinalysis Strips can be read both visually and on the Medline 120 Mini Urine Analyzer (except where noted otherwise). Item No. MPHUA10SG MPHUAURO7 MPHUA5OB MPHUA4OB MPHUA2GP* MPHUAMAC**

Description Medline 10SG Urinalysis Strip Medline URO7 Urinalysis Strip Medline 5OB Urinalysis Strip Medline 4OB Urinalysis Strip Medline 2GP Urinalysis Strip Medline ALB/CRE Urinalysis Strip

Number of Parameters 10 7 5 4 2 2

Influenza A & B / RSV Type of Strip 10SG URO7 5OB 4OB 2GP MAC

Pkg. 100 ea/bt 100 ea/bt 100 ea/bt 100 ea/bt 100 ea/bt 100 ea/bt

Strep

Additional POC

Analytes Item No.

Leukocytes

Nitrite

• • • •

• • • •

MPHUA10SG MPHUAURO7 MPHUA5OB MPHUA4OB MPHUA2GP

Urobilinogen Protein •

• • • • •

pH

Blood

• •

• • •

Specific Gravity •

Ketone

Bilirubin

• •

Glucose Albumin Creatinine • • • • •

Hematology

MPHUAMAC**

Accessories Item No. MPHUABCR MPHUAP87 † ACNUA102 ACNUC011 ACNUC071

Description Medline Barcode Reader Medline Thermal Printer Paper Sticky Printer Paper Liquid Urine Controls, Dropper, 2 x 5mL Liquid Urine Control, Diptube, 2 x 12mL

Pkg. 1 ea 4 ea/pk 4 ea/pk 1 kt 1 kt

*Can only be read visually.

Urinalysis

Chemistry

How to use test strips ‡ Step 1: Immerse strip into urine.

Immunoassay

Step 2: Remove excess urine.

Specialty

** Only for use on Medline 120 Mini Urine analyzer. Can not be visually read. † For use on Medline 120 Mini Urine analyzers and other similar analyzers.

Step 3: Obtain results by analyzer or visual reading.

Contact your Medline Representative or call 1-800-MEDLINE to order yours today.

ESR

OR

Blood Gas

‡ Refer to Product Insert or User’s Manual for complete instructions.

Coagulation Medline Industries, Inc. Three Lakes Drive, Northfield, IL 60093 Medline United States 1-800-MEDLINE (633-5463)

medline.com | info@medline.com

Medline Canada 1-800-396-6996

medline.ca | canada@medline.com

FOLLOW US

Medline México 01-800-831-0898

medlinemexico.com | mexico@medline.com

BLOG

Cardiac LIS/Resources

Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this brochure. ©2017 Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc. MKT1791694 / LIT743R / 2.5M / SG / 10, 3

Forms


Lab Portfolio

Medline iFOB Test Kits MPH70025CTM 25 ea/bx 20.4.36.26.71 82274QW $15.92

Lab Lead Form

Medline iFOBT

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

CRITICAL SCREENING MADE FAST AND EASY.

Immunoassay

Specialty

Simple, non-invasive and effective.

ESR

Immunochemical Fecal Occult Blood Test (iFOBT) Patient-friendly test. Accurate results. Excellent value.

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Medline iFOB Test Kits MPH70025CTM 25 ea/bx 20.4.36.26.71 82274QW $15.92

Lab Lead Form

Medline iFOBT

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

A BETTER FIT FOR DETECTING FECAL OCCULT BLOOD.

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths.* But with proper screening, it is one of the most preventable and curable of cancers.1 CRC guidelines from the American College of Gastroenterology recommend the fecal immunochemical testing (FIT), also called the immunochemical fecal occult blood test (iFOBT), as the preferred cancer detection test to detect occult bleeding.2

iFOB Test Compared to Guaiac Test

When compared to the guaiac-based test, the iFOB test demonstrates higher specificity, sensitivity, patient compliance and cost-effectiveness.3 Comparison

iFOB Test

Traditional Guaiac Test

Test Method

Detects blood by immunoassay. An antibody is prepared that specifically recognizes the globin component of human hemoglobin.3

Detects the presence of blood’s heme component when hydrogen peroxide is added during analysis and oxidizes guaiac to form a blue-colored dye.3

Clarity of Results

Presence of line in test area indicates a positive result; absence of line means a negative result.

Presence of blue color indicates a positive result

Built-in control test area Specificity

Specific analysis for human hemoglobin3

Method relies on simple oxidation and therefore any dietary hemoglobin has the potential to give a false positive, as can drugs or foods that have peroxidase properties.3

Sensitivity

Analytically sensitive to low concentrations of hemoglobin3

Requires a significant quantity of heme to effect a visible color change and are therefore not very sensitive analytically to the presence of blood.3

Dietary or Drug Interactions

None

Yes; certain foods and medications may interact with test results, including red meat, iron, uncooked fruits and vegetables with peroxidase activity, and vitamins C and E3

Samples Required

One sample per test

Three samples per test

Average Reimbursement*

Diagnostic code 82274QW: $21.65** Screening code G0328QW: $21.65**

Diagnostic code 82270: $4.43**

*of cancers that affect men and women in the U.S. **Reimbursement information provided is based on the national average reimbursement paid by Medicare. Values may vary by state. For private payers, check with the appropriate insurance company.

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Medline iFOB Test Kits MPH70025CTM 25 ea/bx 20.4.36.26.71 82274QW $15.92

Lab Lead Form

Medline iFOBT

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV Easy Sampling for Patients

Easy Interpretation for Clinicians

Simple, mess-free collection can help encourage testing compliance.***

Quicker results mean quicker detection. A. Shake collection tube vigorously for 20-30 seconds to ensure the sample is well mixed with buffer.

STEP ONE

Obtain stool for sampling A. Deposit the fecal sample on collection paper or in a clean cup.

STEP TWO

A. Unscrew sampler from collection tube. B. With fecal sample still on collection paper, randomly insert grooved end of sampler into the fecal sample in at least six different sites. C. Insert the sampler into the collection tube and firmly tighten it. Do not reopen.

iFOBT

iFOBT

E. Holding tube vertically above sample well on the cassette, squeeze tube gently to dispense three drops into sample well. F. Read result in 5 to 10 minutes. Do not read after 10 minutes.

Tip Cap

Tip Cap

Urinalysis

iFOBT

Hematology

NEGATIVE C Line only

Chemistry

iFOBT

Shake Tube Well

STEP THREE

Return sample for testing A. Place collection tube into plastic bag with absorbent pad and place bag into mailing envelope. B. Seal envelope, add postage and mail to your doctor or laboratory.

Shake Tube Well

Tube iFOBT

Stab Feces at Six Different Spots

Additional POC

POSITIVE Any visible T

Control Position Test Position

Sampler

Strep

C. Tap collection tube on hard surface to dislodge any trapped air in top of cap.

D. Shake the tube vigorously to mix the sample and the extraction buffer.

Tube

Reddish line at “T” indicates detection of human hemoglobin.

B. Remove test device from foil pouch.

D. Invert tube several times. Unscrew tip cap on collection tube.

Collect small samples

Easy Read Test Results

Sample Well

iFOBT

iFOBT

INVALID No C Line

Immunoassay

Specialty

ESR

***Instructions for use should be read completely before performing the test.

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Medline iFOB Test Kits MPH70025CTM 25 ea/bx 20.4.36.26.71 82274QW $15.92

Lab Lead Form

Medline iFOBT

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

iFOB Is the CRC Screening Test You and Your Patients Have Been Wishing For.

Strep

The United States Preventive Services Task Force recommends that average-risk men and women ages 50-75 get regular colorectal cancer screening.4 The Medline iFOB test allows patients to procure samples in the comfort of their own homes, at their convenience. Simple and fast, this patient-friendly test is non-invasive, requires only one sample per test and provides high sensitivity and specificity.

Additional POC

Features of the iFOB Test

Urinalysis

» CLIA waived » Results in 5 minutes » Mess-free collection tube with specimen applicator » No dietary restrictions; test results specific to human hemoglobin

Hematology

» 99.7% relative accuracy5 » 50ng hHB/mL analytical sensitivity5

ORDERING INFO

Benefits of the iFOB Test » Easy to interpret test results » Allows prompt diagnosis and treatment » Only one sample per test required for enhanced patient compliance » iFOBT is the newer, recommended2,6 technology with higher reimbursement than the guaiac test

Contact your Medline representative or call 1-800-MEDLINE to order yours today.

Item Number

Description

Pkg.

MPH70025CTM

iFOB Test Kit: Test Cassettes, Collection Tubes and Mailers

25 ea/bx

MPH70025CT

iFOB Test Kit: Test Cassettes and Collection Tubes

25 ea/bx

MPH70025M

iFOB Mailers

25 ea/bx

MPH70025T

iFOB Collection Tubes

25 ea/bx

Chemistry

Immunoassay

Specialty Medline Industries, Inc. One Medline Place, Mundelein, IL 60060 Medline United States 1-800-MEDLINE (633-5463)

medline.com | info@medline.com

Medline Canada 1-800-396-6996

medline.ca | canada@medline.com

FOLLOW US

BLOG

Medline México 01-800-831-0898

medlinemexico.com | mexico@medline.com

REFERENCES: 1. Basic Information About Colorectal Cancer. Centers for Disease Control and Prevention. Available at http://www.cdc.gov/cancer/colorectal/ Accessed September 15, 2015. 2. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM. American College of Gastroenterology Guidelines for Colorectal Cancer Screening 2008. Am J Gastroenterol 2009;104:739-750. Available at http://s3.gi.org/physicians/guidelines/CCSJournalPublicationFebruary2009.pdf Accessed September 15, 2015. 3. Allison JE, Fraser CG, Halloran SP, Young GP. Population Screening for Colorectal Cancer Means Getting FIT: The Past, Present, and Future of Colorectal Cancer Screening Using the Fecal Immunochemical Test for Hemoglobin (FIT). Gut and Liver. 2014;8(2):117-130. Available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3964261/ Accessed September 15, 2015. 4. LeFevre M, Siu AL, Bibbins-Domingo K. The Guide to Clinical Preventive Services 2014: Recommendations of the U.S. Preventive Services Task Force. Available at http://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/guide/index.html Accessed September 15, 2015. 5. Data on file. 6. Allison JE, Sakoda LC, Levin TR, et al. Screening for Colorectal Neoplasms With New Fecal Occult Blood Tests: Update on Performance Characteristics. J Natl Cancer Inst. 2007;99(19):1462-1470. Available at http://www.medscape.com/viewarticle/564698 Accessed September 15, 2015.

ESR Blood Gas

Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this brochure. ©2015 Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc. MKT1661938 / LIT560R / 2.5M / SG / 3

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

Influenza A & B BioSign Flu

Sekisui OSOM® Ultra

Quidel Sofia® 2 Flu

Lipid Profile

Medline POC

BD Veritor™

Influenza A & B / RSV

ID NOW Flu

Bleed 17.25” Trim 17” Sofia2 SS_Flu_10.qxp_Layout 1 5/10/17 4:59 PM Page 1

R A P ID D IA GN OS T ICS

Meet patient and staff needs with simple, timely point-of-care testing

www.osomtests.com ®

Strep

• Easy-to-read results with 1-button functionality and minimal hands-on time to meet your staff’s demands • Flexible workflow options to adapt to your workplace needs

The ART of Flu Testing • Timely, accurate results (<11 minutes for Flu A+B and RSV; <6 minutes for Group A Strep1,3,4) for minimized wait times

Ultra Flu A&B Test

BD Veritor Plus eLearning platform simplifies staff trainingmanagement Accurate,•objective and™automated Secure, remote instrument results in as few as 3 minutes through the Virena ecosystem

FOR THE DETECTION OF INFLUENZA TYPE A AND TYPE B NUCLEOPROTEIN ANTIGENS

• Quality control and traceability offered with the

BD Veritor™ InfoScan module Excellent performance compared to molecular and viral culture methods

4 ACCURATE; CLIA Waived: Nasal and Nasopharyngeal (NP) Swabs. CLIA WAIVED: NASAL AND NASOPHARYNGEAL (NP) SWABS1

Influenza A & B Test

Rapid results for immediate treatment 1

PO S ITIVE P E R C E N T AGR EE ME N T ( PPA)

N EGATIVE P E R C E N T AGR E E ME N T ( N PA)

INFLUENZA A

8 9 .2 % 9 5 % C I: 8 3 .0 - 9 3 .4 %

9 9 .4 % 9 5 % C I: 9 7 .9 - 9 9 .8 %

INFLUENZA B

8 6 .4 % 9 5 % C I: 8 0 .1 - 9 0 .9 %

9 9 .0 % 9 5 % C I: 9 7 .1 - 9 9 .7 %

Bleed 11.25” Trim 11”

THE RESULTS YOU NEED NOW.

S WAB S AMP L E S

Integrated data management automatically stores test and user history

Flexible, dual mode testing and simple, CLIA-waived procedures for a variety of laboratory environments

Sofia 2 with Advance Result Technology

4 SIMPLE PROCEDURE; Easy to use premeasured extraction buffer for swabs and

Delivering accurate, objective and automated results in as few as three minutes!

unique cassette design for streamlined workflow. 4 CONFIDENT RESULTS; Easy interpretation of results in 10-15 minutes.

MOLECULAR. IN MINUTES.™

ID NOW INFLUENZA A & B 2 ™

User and patient ID captured with onboard barcode scanner

NP aspirate/wash samples. Compatible with viral transport media. 1. Package Insert.

Ordering information

Cat. no.

Qty.

BD Veritor™ System RSV CLIA-waived kit

256038

30 tests

BD Veritor™ System RSV (Moderately complex)

256042

30 tests

BD Veritor™ System Group A Strep CLIA-waived kit

256040

30 tests

BD Veritor™ System Flu A+B CLIA-waived kit

256045

30 tests

BD Veritor™ System Flu A+B (Moderately complex)

256041

30 tests

BD Veritor™ Plus System Analyzer

256066

1

BD Veritor™ InfoScan module

256068

1

USB printer cable

443907

1

Additional POC

The fastest molecular flu test just got faster and even better.

ART ≥ 3mins

Advance Result Technology

4 FLEXIBLE SPECIMEN TYPE; Accurate detection with nasal swabs, NP swab and

Harness the power of simplicity The BD Veritor™ System enhances POC testing for CLIA-waived Flu A+B, Group A Strep and RSV* assays A streamlined point-of-care diagnostic experience is at hand with the BD Veritor™ Plus system. Offering ease of use, workflow flexibility and fast, traceable results.

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Now with early detection - positive results in as few as 5 minutes

1

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Detects up to 42% more true positives

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Room temperature storage

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CLIA waived

than RADTs

2

Urinalysis

References: 1. BD Veritor System for Rapid Detection of Flu A+B, CLIA-waived kit [package insert], 8087667. Franklin Lakes, NJ: Becton, Dickinson and Company. 2. BD Veritor System for Rapid Detection of Flu A+B, laboratory kit [package insert], 8087666. Franklin Lakes, NJ: Becton, Dickinson and Company. 3. BD Veritor System for Rapid Detection of Respiratory Syncytial Virus (RSV), package insert, 8086098. Franklin Lakes, NJ: Becton, Dickinson and Company. 4. BD Veritor System for Rapid Detection of Group A Strep, laboratory kit [package insert], 8087675. Franklin Lakes, NJ: Becton, Dickinson and Company.

BD.com/VeritorSystem

*respiratory syncytial virus

BD, the BD Logo, and BD Veritor are trademarks of Becton, Dickinson and Company or its affiliates. © 2020 BD. All rights reserved. 394-US-0320 June 2020

Quidel

Roche Liat® Molecular Influenza

Cepheid GeneXpert® Xpress

l Rapid Diagnostics

l quidel.com

l 800.874.1517

RADTs, Rapid antigen detection tests (lateral flow/rapids)

l 858.552.1100

Sekisui Silaris RSV

Sekisui Silaris Flu

Alere BinaxNOW®RSV

Hematology

S_Flu_ss_ƒ.qxp_Layout 1 10/31/19 12:09 PM Page 1

GeneXpert Xpress ®

Front-line Access and Control. Everywhere You Need It.

perhaps it’s the flu.

Flu

The only real-time PCR system that’s CLIA-waived for Influenza A/B, Influenza A/B & RSV and Strep A, delivering accurate results in 20 minutes or less.

This single test accurately aids in the diagnosis of RSV using the trusted performance of PCR technology.

With the cobas® Liat® PCR system, you can count on quick, accurate results in just three simple steps. There’s no need to confirm negative results – so you can provide optimal treatment faster.

Flu Facts

RSV Facts

INFLUENZA REMAINS A MAJOR THREAT TO THAT IN A TYPICAL INFLUENZA SEASON, 5-20% OF THE US POPULATION FALLS ILL AND MORE THAN 200,000 ARE HOSPITALIZED.

In a study recently published in the

more accurate in terms of sensitivity, it’s also easier to use.1

RSV USUALLY CAUSES MILD RESPIRATORY ILLNESS, BUT IT CAN BE SERIOUS, ESPECIALLY IN INFANTS AND OLDER ADULTS.

THE MOST SEVERE OUTCOMES OCCUR IN PEOPLE 65 AND OLDER, VERY YOUNG

Journal of Clinical Microbiology, cobas rapid detection of Influenza A and B. The

ALMOST ALL CHILDREN WILL BE INFECTED WITH RSV BY THEIR SECOND BIRTHDAY.

PUBLIC HEALTH. RECENT STUDIES SHOW

Not all molecular tests are the same.

IT IS THE MOST COMMON CAUSE OF BRONCHIOLITIS AND PNEUMONIA IN

CHILDREN, AND THOSE WITH UNDERLYING

sensitivity and specificity1 for influenza A and B with cobas Liat.

study found that cobas Liat is not only

Compare to Alere i sensitivity. ™

HEALTH CONDITIONS. 1

Standardized molecular testing for any healthcare setting — from community hospitals to physician offices and specialty clinics

1, 2

73.3% Influenza A 93.3% Influenza B

“The Liat test has fewer steps, which can be completed by the operator in less than 1 minute.” — Journal of Clinical Microbiology

Quidel QuickVue® RSV

BinaxNOW RSV ®

The BinaxNOW® assay was sensitive and specific in detecting RSV infections over three consecutive winter seasons. This is reassuring, given the frequency of which clinical decisions are based on these rapid tests.¹ This test performed particularly well in neonates, those children at highest risk for apnea and other severe complications of RSV disease.¹

Make the right treatment decisions right away.

Liat and Alere™i were compared for

Chemistry

RSV

This single test accurately aids in the diagnosis of Influenza A&B using the trusted performance of PCR technology.

For In Vitro Diagnostic Use.

Quidel Sofia® 2 RSV

CHILDREN YOUNGER THAN 1 YEAR OF AGE. 1

Test

Test

BD Veritor™ RSV

Now in the clinical lab

ID NOW RSV

Features & Benefits  Results: 15 minutes  Onboard extraction: no extra steps  Sample types: nasopharyngeal swab and nasal wash

Immunoassay

 Shelf life: up to 24 months2  One Step: no additional reagents needed

Benefits of Rapid Diagnosis  Guide appropriate therapy  Avoid unnecessary antibiotic use

Why test for RSV?  90,000 hospital admissions per year nationally1  Clinically difficult to differentiate RSV from other

Actual size Actual size

serious respiratory viruses1

To learn more about rapid detection of RSV, contact your local Account Executive.

Roche Liat Molecular RSV

Specialty

ESR

BD Veritor System analyzes... Quick, easy, accurate! Diagnosing and managing respiratory syncytial virus (RSV) is serious business. In the U.S., RSV is estimated to be responsible for 73,400 to 126,300 hospitalizations annually for bronchiolitis and pneumonia alone among children younger than one year.1 In children hospitalized with an RSV infection, it is believed to be the most common viral cause of death in children younger than five years, particularly in children younger than one year.2

Due to potentially serious complications that may result from RSV, prompt detection and management are critical. The QuickVue RSV test is a simple and accurate test that can aid in diagnosing RSV quickly and confidently, giving the results you need. Right. Now.

Rapid Diagnosis and Treatment • Results in 15 minutes or less.

Advantages of QuickVue RSV • High sensitivity and specificity (see back for performance details). • Each kit contains everything needed to perform the test, including nasopharyngeal swabs and Positive and Negative Controls. • Room temperature storage with up to 24-month shelf life from date of manufacture. • Cleared for use with children up to 18 years of age. • When run in conjunction with a QuickVue Influenza test, a single specimen sample may be used for both tests, eliminating the need to collect multiple samples, causing less patient discomfort while saving valuable time. • Synagis does not interfere with the QuickVue RSV test.

The ART of RSV Testing Secure, remote instrument management through the Virena ecosystem

Accurate, objective and automated results in as few as 3 minutes Excellent performance compared to molecular and viral culture methods

Integrated data management automatically stores test and user history

Flexible, dual mode testing and simple, CLIA-waived procedures for a variety of laboratory environments

User and patient ID captured with onboard barcode scanner

Sofia 2 with Advance Result Technology Accurate Detection • Accurate detection with choice of sample type: • 99% sensitivity with nasopharyngeal aspirate. • 92% sensitivity with nasopharyngeal swab. • 83% sensitivity with nasal/nasopharyngeal wash. Easy to Use • CLIA waived. • Dipstick test format. • 3-step procedure, approx. 30 seconds hands-on time. • Only 1 reagent. • Two-color endpoint for easy to read and interpret results.

Delivering accurate, objective and automated results in as few as three minutes!

ART ≥ 3mins

...All that you see

and all that you can’t.

MOLECUL AR. IN MINUTES.™

ID NOW RSV ™

The fastest RSV results when it matters most

Advance Result Technology

For Rapid Detection of RSV* For Rapid Detection of Flu A+B

• Technology-verified Performance – Incorporates state of the art technologies that deliver results For Rapid Detection of Group you can trust

Collins P., Chanock R., Murphy B. Fields Virology. Fourth Edition. Volume 1. Chapter 45 - Respiratory Syncytial Virus. Lippincot Williams and Wilkins. (2001). Thompson W. et al. Mortality Associated With Influenza and Respiratory Syncytial Virus in the United States. JAMA, January 8, 2003 - Vol 289, No. 2.

1 2

• Multiple Sample Types – Validated to be used with nasopharyngeal washes/aspirates, and nasopharyngeal swabs in transport

For more information on QuickVue RSV test kits, visit our website or call your Quidel Account Manager at 1.800.874.1517 (U.S. only) or 858.552.1100 (outside U.S.). Quidel Corporation • Worldwide Headquarters • 10165 McKellar Court • San Diego, CA 92121 USA • www.quidel.com

Quidel

l Rapid Diagnostics

l quidel.com

l 800.874.1517

l 858.552.1100

• Convenient Kit Configuration– Fully customized kit to test and

deliver results in minutes A STREP

• Objective Results – Easy to read digital display eliminates subjective interpretation

Actionable results in 13 minutes or less

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25% more true positives than RADTs1,2

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Room temperature storage

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CLIA waived

New test uses one sample to give three results in 20 minutes – Influenza A, Influenza B and RSV.

Make the right treatment decisions right away. Quick and accurate diagnosis can greatly benefit patients who contract respiratory syncytial virus (RSV). With the cobas® Liat® PCR System, you can count on quick, accurate results in just three simple steps — so you can provide optimal treatment faster.

*Respiratory Syncytial Virus BD-415 RSV Selling Tool_DR.indd 1

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9/26/12 1:23 PM

Blood Gas

odds are it’s RSV.

Coagulation

One sample. Three results. Test for Influenza A, Influenza B and RSV with one sample. No age restrictions. A fast diagnosis is critical both for infants and elderly patients. CLIA-waived. A real-time PCR system that is CLIAwaived and delivers results in 20 minutes.

Cardiac LIS/Resources Forms


Lab Portfolio

BioSign Flu A & B PBOBSP510 25 ea/box 20.10.44.32.32 87804QW x 2 $33.10

Lab Lead Form

BioSign Flu

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

THE RESULTS YOU NEED NOW.

Specialty

ESR

Influenza A & B Test

Rapid results for immediate treatment 1

Blood Gas Coagulation

Cardiac LIS/Resources Forms


BioSign Flu A & B PBOBSP510 25 ea/box 20.10.44.32.32 87804QW x 2 $33.10

Placement Agreement

BioSign Flu

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

The Influenza A & B Test provides a simple, rapid method to aid in the diagnosis of influenza A & B using nasal swab specimens. This easyto-use format and rapid results allow for point-of-care testing.

___ ___

C

Positive Flu A & B

C B A

C B A

Strep

Additional POC

lue

INCUBATE Insert the specimen swab in the swab stand. » Spin swab 3 times to mix the specimen » Let stand 1 minute » Spin swab 3 times again

Negative

Urinalysis

C B A

Hematology

Invalid

3 100

80

Flu B%

C B A

FLIP & TAP Tip the device and gently tap the device to ensure the liquid flows.

80

60

60

40

40

20

20

Specifity: 99.4

Positive Flu B

Inf

C

Benefits of Rapid Diagnosis » Guide appropriate therapy » Avoid unnecessary antibiotic use » Empower timely treatment decisions

Format: Cassette

0

Positive Flu A

Date nz _ ID_______ a ___ ___

2 2

PERFORMANCE* Flu A%

EXTRACT Empty entire contents of a reagent capsule into the extraction well.

C B A

Features of the Influenza A & B Test » Positive results in 10 minutes » Nasal and nasopharyngeal swabs, nasal aspirate/wash specimens » CLIA Waived for nasal and nasopharyngeal swab samples » Dual reimbursement 1

100

EASY TO READ B A

1

nI ulf ne taD az________eDI

EASY TO USE

INFLUENZA A & B TEST

B A

2

Lab Portfolio

Sensitivity: 89.2

0

4 Specifity: 99.0

Sensitivity: 86.4

C B A

C B A

C B A

READ Lay device back down, and interpret results at 10 to 15 minutes.

C B A

C B A

ORDERING INFO Item No.: Description: Pkg:

PBOBSP510 Influenza A & B Test 25 ea/bx

*Versus PCR.

Contact your Medline representative or call 1-800 MEDLINE to order yours today. Medline Industries, Inc. Three Lakes Drive, Nothfield, IL 60093 Medline United States 1-800-MEDLINE (633-5463)

medline.com | info@medline.com

Medline Canada 1-800-396-6996

medline.ca | canada@medline.com

FOLLOW US

BLOG

Chemistry

Immunoassay

Specialty

ESR

Medline México 01-800-831-0898

medlinemexico.com | mexico@medline.com

REFERENCES: 1. Actual reimbursement may vary. 2. Williams, KM, Jackson MA, Hamilton M. Rapid Diagnostic Testing for URIs in Children: Impact on Physician Decision Making and Cost. Infect. Med. 19(3): 109-111, 2002. Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this brochure. ©2018 Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc. MKT18104395 / 750R / 3M / SG / 15

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Sekisui OSOM OSOM1006 25 ea/bx G20.9.84.15.23 87804QW x 2 $33.10

Lab Lead Form

Sekisui OSOM Ultra

RAPID DIAGNOSTICS

HbA1c and Glucose

www.osomtests.com ®

Lipid Profile

Medline POC

Ultra Flu A&B Test

Influenza A & B / RSV

FOR THE DETECTION OF INFLUENZA TYPE A AND TYPE B NUCLEOPROTEIN ANTIGENS 4 ACCURATE; CLIA Waived: Nasal and Nasopharyngeal (NP) Swabs.

Strep

CLIA WAIVED: NASAL AND NASOPHARYNGEAL (NP) SWABS1 S WA B S A M P L E S

POSITIVE PERCENT AG R E E M E N T ( P PA )

N E G AT I V E P E R C E N T AG R E E M E N T ( N PA )

INFLUENZA A

89.2% 95% CI: 83.0-93.4%

99.4% 95% CI: 97.9-99.8%

INFLUENZA B

86.4% 95% CI: 80.1-90.9%

99.0% 95% CI: 97.1-99.7%

Additional POC

Urinalysis

4 SIMPLE PROCEDURE; Easy to use premeasured extraction buffer for swabs and unique cassette design for streamlined workflow. 4 CONFIDENT RESULTS; Easy interpretation of results in 10-15 minutes.

Hematology

4 FLEXIBLE SPECIMEN TYPE; Accurate detection with nasal swabs, NP swab and NP aspirate/wash samples. Compatible with viral transport media. 1. Package Insert.

Chemistry Sekisui Diagnostics, LLC (AMERICAS) 4 Hartwell Place Lexington, MA 02421 Phone: 800 332 1042 Fax: 800 762 6311 Email: osomrapidtests@sekisui-dx.com ISO 13485 Certified

®

Ultra Flu A&B Test SIMPLE PROCEDURE

CONFIDENT RESULTS

Squeeze

C

B A

Dateuen __ z ID__ ____ a ____ __

Infl

1

Sekisui Diagnostics (UK) Limited (INTERNATIONAL) Liphook Way, Allington, Maidstone, Kent, ME16 0LQ, UK Phone: +44 1622 607800 Fax: +44 1622 607801 Email: info@sekisui-dx.com ISO 9001 Certified, ISO 13485 Certified

2

Date ID

3

Specialty

Any visible A and/or B Line(s) with C Line is positive. C B A

C B A

Raise the device upright and let stand 1–2 seconds.

e

Date_ nz ID_______ a ____ __

Infl u

Add premeasured extraction buffer.

Place patient swab in well. Mix slightly by rotation before and after 1 MINUTE INCUBATION.

Influenza

C B A

Immunoassay

C Line only Negative (–)

C B A

C B A

C

B A

A line: B line: A & B lines: Influenza Influenza Influenza type A type B type A & B

No C Line Invalid C B A

C B A

C B A

Repeat with new sample and device.

ESR

Additional Performance Data-Moderate Complexity: NP aspirate

ORDERING INFORMATION ***

4

Gently tap and lay on flat surface.

5

Start timing. Interpret Results in 10-15 minutes.

N P A S P I R AT E S A M P L E S

SENSITIVITY

SPECIFICITY

INFLUENZA A

95.3%

85.7%

INFLUENZA B

91.6%

97.5%

DESCRIPTION

C O N F I G U R AT I O N

CATA L O G #

S TO R AG E

O S O M U LT R A F L U A & B T E S T

25 TESTS 2 EXTRA FOR QC INSIDE

1006

ROOM TEMP

O S O M U LT R A F L U A & B C O N T R O L K I T

5 X P O S F L U A / B S WA B S 5 X N E G F L U A / B S WA B S

1005

ROOM TEMP

O S O M U LT R A F L U A & B N A S O P H A RY N G E A L WA S H / A S P I R AT E K I T

50 PIPETTES; 5ML EXTRACTION REAGENT

1007

ROOM TEMP

Blood Gas Coagulation

CPT CODE F L U A - 8 7 8 0 4 Q W * ( S WA B S O N LY ) 8 7 8 0 4 ( A S P I R AT E O N LY ) F L U B - 8 7 8 0 4 Q W * - 5 9 * * ( S WA B S O N LY ) 8 7 8 0 4 - 5 9 * * ( A S P I R AT E O N LY )

Cardiac LIS/Resources

*”QW” modifier is added to report use of CLIA-waived test system(s) for Medicare/Medicaid claims. **”59” modifier used to indicate separate test. *** Additional Accessories (Swabs and Swab With Transport Tubes) are available. OSOM® is a registered U.S. trademark of Sekisui Diagnostics, LLC. Because every result matters ™ is a trademark of Sekisui Diagnostics. © 2016 Sekisui Diagnostics, LLC. All rights reserved. MADE IN THE USA

1532-1 10/16

Forms


Lab Portfolio

Quidel Sofia Influenza A+B FIA QDL20218 (FLU) 25 ea/bx L20.13.76.1.33 87804QW x 2 $33.10

Lab Lead Form

Sofia2 SS_Flu_10.qxp_Layout 1 5/10/17 4:59 PM Page 1 Quidel Sofia 2 Flu

HbA1c and Glucose

Lipid Profile

Medline POC

The ART of Flu Testing Accurate, objective and automated results in as few as 3 minutes

Secure, remote instrument management through the Virena ecosystem

Excellent performance compared to molecular and viral culture methods

Integrated data management automatically stores test and user history

Flexible, dual mode testing and simple, CLIA-waived procedures for a variety of laboratory environments

User and patient ID captured with onboard barcode scanner

Influenza A & B / RSV

Strep

Additional POC

Sofia 2 with Advance Result Technology Delivering accurate, objective and automated results in as few as three minutes!

Urinalysis Hematology

Chemistry

ART ≥ 3mins

Advance Result Technology

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources

Quidel

l Rapid Diagnostics

l quidel.com

l 800.874.1517

l 858.552.1100

Forms


Lab Portfolio

Quidel Sofia Influenza A+B FIA QDL20218 (FLU) 25 ea/bx L20.13.76.1.33 87804QW x 2 $33.10

Lab Lead Form

Sofia2 SS_Flu_10.qxp_Layout 1 5/10/17 4:59 PM Page 2 Quidel Sofia 2 Flu

HbA1c and Glucose Sofia Influenza A+B FIA – Procedures Nasal/Nasopharyngeal Swab Procedure

OR

Nasopharyngeal Aspirate/Wash Procedure

Lipid Profile

Medline POC Influenza A & B / RSV

Strep Sofia 2 Development Modes WALK AWAY Mode – Walk away and multitask

READ NOW Mode – Batch multiple samples per hour

15

3-15mins

Additional POC

Urinalysis Hematology

Sofia Influenza A+B FIA Cleared as a Class II rapid antigen test under the new FDA reclassification requirements Approved for collection with Nasal swabs, NP swabs and NP aspirate/wash samples Single specimen may be used for both Sofia RSV and Sofia Influenza Compatible with viral transport media

CLIA Waiver Studies

Samples

Influenza A Influenza B

Room temperature storage 21-month shelf life from date of manufacture

Chemistry

Sofia Influenza A+B FIA Results vs. Culture* Sens

Spec

NS/NPS

93%

95%

NPA/NPW

99%

96%

NS/NPW

90%

96%

NPA/NPW

88%

96%

*Refer to the Package Insert for additional performance claims.

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac SL9014 l SS2021803EN00 (05/17)

Sofia Influenza A+B FIA – 25 Test Kit: Catalog #20218

Class II CERTIFIED

LIS/Resources

CLIA

WAIVED

Forms


Lab Portfolio

17.25” m 17” BD Veritor

BD Veritor Strep BDD256040 (Strep) 30 ea/bx G20.2.73.7.20 87880QW $16.53

BD Veritor BDD256045 (Flu) 30 ea/bx G20.11.96.0.67 87804QW x 2 $33.10

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

Harness the power of simplicity The BD Veritor™ System enhances POC testing for CLIA-waived Flu A+B, Group A Strep and RSV* assays A streamlined point-of-care diagnostic experience is at hand with the BD Veritor™ Plus system. Offering ease of use, workflow flexibility and fast, traceable results.

ESR Blood Gas Coagulation

Cardiac LIS/Resources

*respiratory syncytial virus

Forms


BD Veritor Strep BDD256040 (Strep) 30 ea/bx G20.2.73.7.20 87880QW $16.53

Lab Portfolio

Lab Lead Form

BD Veritor

BD Veritor BDD256045 (Flu) 30 ea/bx G20.11.96.0.67 87804QW x 2 $33.10

Bleed 17.25” Trim 17”

HbA1c and Glucose

Lipid Profile

BD Veritor™ Plus System Enhancing the point-of-care testing experience Challenges facing point-of-care testing can include ambiguous test results, complex work flows, training and documentation. These challenges can lead to extended time to results and delays in diagnosis. The BD Veritor™ Plus system is designed to address these challenges with: • Objective, unambiguous results, enhancing diagnostic confidence

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

• Flexible workflow options • Traceability and data storage

Chemistry

• Timely results—less than 11 minutes for Flu A+B and RSV, and less than 6 minutes for Group A Strep1,3,4—reducing patient wait times Train your staff with ease

Immunoassay

Enable workflow flexibility

• Delivers easy-to-read results using a digital display

• Select the mode to fit your workflow:

• Simplifies staff training with the BD Veritor™ Plus eLearning platform, featuring assay training modules, how-to videos, dashboards and more

– For batching, use Analyze Now mode. Incubate specimen for time recommended for each assay, then insert test device into Analyzer; result is displayed within seconds

• Minimizes training time and facilitates operation with intuitive sample processing • CLIA-waived status allows for simple training for novice and nonlab personnel to confidently test for Flu A+B, Group A Strep and RSV

– For multitasking, use Walk Away mode. Add specimen to test device and insert into Analyzer for automatic incubation and analysis

Specialty

Acc accu

ESR

• Proven performance

• Advanced particle te using a proprietary p Blood Gas colloidal m modified test performance

• Adaptive read techn

reduce false-positive Coagulation

background and non

• Timely results may i

– Flu A+B or RSV resu

Cardiac Group A Strep resu

• Reduces potential man sample processing

LIS/Resources – Uses prefilled unit

– Sample swab is ins and removed. The

Forms


Lab Portfolio

BD Veritor Strep BDD256040 (Strep) 30 ea/bx G20.2.73.7.20 87880QW $16.53

17.25” m 17” BD Veritor

BD Veritor BDD256045 (Flu) 30 ea/bx G20.11.96.0.67 87804QW x 2 $33.10

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC

Influenza A & B / RSV Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Accelerate accurate results • Proven performance for Flu A+B detection vs PCR1,2 • Advanced particle technology enhances sensitivity by using a proprietary process to produce highly stable, modified colloidal metal particles, helping improve test performance • Adaptive read technology helps improve specificity to reduce false-positive results by compensating for background and nonspecific binding

Facilitate quality control • BD Veritor™ InfoScan module provides reliable quality control and traceability through customizable documentation functionality (user ID, specimen ID and test kit/lot) • May reduce risk of reporting errors by minimizing manual transcription and leveraging data storage/ download and printing capabilities via USB

Specialty

ESR Blood Gas Coagulation

• Timely results may improve patient experience – Flu A+B or RSV result in less than 11 minutes; Group A Strep result in less than 6 minutes1,3,4 • Reduces potential manual errors by streamlining sample processing – Uses prefilled unitized tubes color-coded by reagent type – Sample swab is inserted into tube, expressed and removed. The sample is then added to the device

Cardiac LIS/Resources Forms


Lab Portfolio

BD Veritor Strep BDD256040 (Strep) 30 ea/bx G20.2.73.7.20 87880QW $16.53

Lab Lead Form

BD Veritor

BD Veritor BDD256045 (Flu) 30 ea/bx G20.11.96.0.67 87804QW x 2 $33.10

Bleed 17.25” Trim 17”

HbA1c and Glucose

Meet patient and staff needs with simple, timely point-of-care testing • Easy-to-read results with 1-button functionality and minimal hands-on time to meet your staff’s demands • Flexible workflow options to adapt to your workplace needs • Timely, accurate results (<11 minutes for Flu A+B and RSV; <6 minutes for Group A Strep1,3,4) for minimized wait times • BD Veritor™ Plus eLearning platform simplifies staff training • Quality control and traceability offered with the BD Veritor™ InfoScan module

Lipid Profile

Medline POC

Influenza A & B / RSV Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty Ordering information

Cat. no.

Qty.

BD Veritor™ System RSV CLIA-waived kit

256038

30 tests

BD Veritor™ System RSV (Moderately complex)

256042

30 tests

BD Veritor™ System Group A Strep CLIA-waived kit

256040

30 tests

BD Veritor™ System Flu A+B CLIA-waived kit

256045

30 tests

BD Veritor™ System Flu A+B (Moderately complex)

256041

30 tests

BD Veritor™ Plus System Analyzer

256066

1

BD Veritor™ InfoScan module

256068

1

USB printer cable

443907

1

References: 1. BD Veritor System for Rapid Detection of Flu A+B, CLIA-waived kit [package insert], 8087667. Franklin Lakes, NJ: Becton, Dickinson and Company. 2. BD Veritor System for Rapid Detection of Flu A+B, laboratory kit [package insert], 8087666. Franklin Lakes, NJ: Becton, Dickinson and Company. 3. BD Veritor System for Rapid Detection of Respiratory Syncytial Virus (RSV), package insert, 8086098. Franklin Lakes, NJ: Becton, Dickinson and Company. 4. BD Veritor System for Rapid Detection of Group A Strep, laboratory kit [package insert], 8087675. Franklin Lakes, NJ: Becton, Dickinson and Company.

BD.com/VeritorSystem BD, the BD Logo, and BD Veritor are trademarks of Becton, Dickinson and Company or its affiliates. © 2020 BD. All rights reserved. 394-US-0320 June 2020

ESR

Harnes Blood Gas

The BD Veritor Coagulation Group Flu A+B,

A streamlined point-of-ca Offering ease of use, wor Cardiac

LIS/Resources *respiratory syncytial virus

Forms


Lab Portfolio

Abbott ID Now Influenza A&B ALR427000 24 ea/bx L20.46.46.3.83 87502QW $95.80

Lab Lead Form

ID NOW Flu

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

MOLECULAR. IN MINUTES.™

ID NOW INFLUENZA A & B 2 ™

The fastest molecular flu test just got faster and even better. nn

Now with early detection - positive results in as few as 5 minutes

nn

Chemistry

Immunoassay

Specialty

ESR

1

Detects up to 42% more true positives than RADTs

Additional POC https://source.medline. com/sitepages/materials. aspx?item=https://collaboration. medline.com/department/sales/ Urinalysis materials/Sales%20Documents/ Hemoglobin%20-%20LIT1056%20 -%20Hb%20201+Product%20Sheet. pdf Hematology

Blood Gas

2

nn

Room temperature storage

nn

CLIA waived

Coagulation

Cardiac LIS/Resources RADTs, Rapid antigen detection tests (lateral flow/rapids)

Forms


Lab Portfolio

Abbott ID Now Influenza A&B ALR427000 24 ea/bx L20.46.46.3.83 87502QW $95.80

Lab Lead Form

ID NOW Flu

HbA1c and Glucose

ID NOW Influenza A & B 2 ™

Lipid Profile

SPEED – THE FASTEST MOLECULAR INFLUENZA A & B TEST FOR EXPEDITING WORKFLOW

3X

ID NOW IS UP TO 3X FASTER

nn

8X

ID NOW IS UP TO 8X FASTER

MINS

4-16

detected within 7 minutes

1

Negative results in 13 minutes

15-40

MINS

Medline POC

few as 5 minutes, with 95% nn

5-13

Positive results detected in as

3

Influenza A & B / RSV

Strep

MINS

Additional POC ID NOW Influenza A & B 2

RADTs

Other Rapid Molecular

Urinalysis PERFORMANCE – SUPERIOR SENSITIVITY ENHANCES CLINICAL CONFIDENCE Detects up to 42% more true positives than RADTs Reduces unnecessary antibiotic usage

nn

RADTs SENSITIVITY 2

2

53.9%

nn

ID NOW INFLUENZA A & B 2 VS. PCR 3 Direct Swab READER TECHNOLOGY 4 SENSITIVITY

78.7%

ID NOW FLU 23 SENSITIVITY

0%

96.3% PCR used as reference method

nn nn nn nn

Specificity

Flu A

96.3%

97.4%

Flu B

100%

97.1%

VTM

Sensitivity

Specificity

Flu A

92.8%

98.5%

Flu B

100%

97.7%

100%

EASE OF USE - SIMPLIFYING THE TEST PROCESS nn

Sensitivity

Room temperature storage eliminates need for refrigeration CLIA waived nasal or nasopharyngeal swabs, for both Direct and VTM Integrated pipette eliminates manual pipetting for direct samples Standardized respiratory trio (Influenza A & B, RSV, Strep A) across all sites of care Bi-directional connectivity to industry leading RALS ® platform facilitates satellite testing and remote management

Chemistry

Immunoassay

Specialty

ESR ORDER INFORMATION PRODUCT NAME

PRODUCT CODE

ID NOW INFLUENZA A & B 2 - 24 TEST KIT

427-000

ID NOW INFLUENZA A & B - CONTROL SWAB KIT

425-080

Blood Gas

CPT CODE: 87502-QW ®

FOR MORE INFORMATION, CONTACT YOUR LOCAL ABBOTT REPRESENTATIVE OR VISIT ALERE.COM. 1. 2. 3. 4.

Hematology

Moore N, et al. Evaluation of the ID NOW ™ Influenza A & B 2 Assay. 2018 ASM Clinical Virology Symposium, West Palm Beach, FL. Poster. Chartrand et al, Accuracy of Rapid Influenza Diagnostic Tests A Meta-analysis; Ann-Intern Med. 2012; 156;500-511 ID NOW Influenza A & B 2 Product Insert Veritor Product Insert

VTM, viral transport medium © 2018 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. Any photos displayed are for illustrative purposes only. Any person depicted in such photos is a model. IDDM170980 120004452-03 12/18

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Roche Cobas Liat BID7341890190 20 ea/bx L20.50.00.6.92 87502QW $95.80

Lab Lead Form

Roche Liat Molecular Influenza

HbA1c and Glucose

Lipid Profile

perhaps it’s the flu. The only real-time PCR system that’s CLIA-waived for Influenza A/B, Influenza A/B & RSV and Strep A, delivering accurate results in 20 minutes or less.

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Make the right treatment decisions right away. With the cobas® Liat® PCR system, you can count on quick, accurate results in just three simple steps. There’s no need to confirm negative results – so you can provide optimal treatment faster.

Chemistry

Immunoassay

Specialty

Not all molecular tests are the same.

ESR

In a study recently published in the Journal of Clinical Microbiology, cobas Liat and Alere™i were compared for rapid detection of Influenza A and B. The

sensitivity and specificity1 for influenza A and B with cobas Liat.

Coagulation

study found that cobas Liat is not only more accurate in terms of sensitivity, it’s also easier to use.1

Blood Gas

Compare to Alere™i sensitivity.1, 2 73.3% Influenza A 93.3% Influenza B

“The Liat test has fewer steps, which can be completed by the operator in less than 1 minute.” — Journal of Clinical Microbiology

Cardiac LIS/Resources Forms


Lab Portfolio

Roche Cobas Liat BID7341890190 20 ea/bx L20.50.00.6.92 87502QW $95.80

Lab Lead Form

Roche Liat Molecular Influenza

HbA1c and Glucose

The cobas Liat advantages are clear.

Lipid Profile

cobas Liat

Alere™i

Rapid Antigen Testing

1. Test in any setting

Medline POC

2. Molecular testing

3. Real-time PCR

4. CLIA-waived for Influenza A/B, Influenza A/B & RSV and Strep A

5. One test, three results (Influenza A, Influenza B & RSV)

6. Walk-away workflow

7. Closed system

Influenza A & B / RSV

Strep

Additional POC

Cut steps. Speed up treatment.

7

Steps

3

Steps

Urinalysis

Alere™i testing method Hematology

*The test must be confirmed within 10 minutes. Otherwise, the instrument will time out, and the test base must be discarded.

1

2

3

4

5

6

7

Open lid.

Insert orange test base.*

Insert blue sample receiver and warm up.

Collect sample and mix it in blue sample receiver.

Connect white cartridge to blue sample receiver.

Place white cartridge on top of orange test base.

Start test.

cobas Liat protocol: Just test and walk away.

1

2

3

Collect sample and add to assay tube.

Scan assay tube and sample.

Insert assay tube to start test.

Fewer steps. Faster treatment. Lab-quality results.

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Save time when your patients need it most with the cobas Liat System. To learn more, visit us at: go.roche.com/pcrtest © 2016 Roche Diagnostics, North America. All rights reserved. Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 1-800-852-8766 Frederick S. Nolte, Lori Gauld, Susan B. Barrett, “Direct Comparison of Alere i and cobas Liat Influenza A and B Tests for Rapid Detection of Influenza Virus Infection,” Journal of Clinical Microbiology, Volume 54, Number 11, November 2016. “The Roche Liat test is cleared and CLIA waived only for swabs in VTM. The Alere test is cleared for both sample types but only CLIA waived for direct nasal swabs. It is considered moderate complexity for swabs in viral transport medium.,” Madeleine Johnson, “Roche’s POC Molecular Flu Test Shows Advantages Over Alere in Head-to-Head Study,” genomeweb, accessed September 7, 2016.

1 2

Cardiac LIS/Resources Forms


Lab Portfolio

Cepheid Xpress Flu CEQPRSFLU10CW 10 ea/ bx 20.45.10.10.25 87502QW $95.80

Lab Lead Form

Cepheid GeneXpert Xpress

HbA1c and Glucose

GeneXpert® Xpress

Lipid Profile

Front-line Access and Control. Everywhere You Need It. Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas

Standardized molecular testing for any healthcare setting — from community hospitals to physician offices and specialty clinics

Coagulation

Cardiac LIS/Resources For In Vitro Diagnostic Use.

Forms


Lab Portfolio

Cepheid Xpress Flu CEQPRSFLU10CW 10 ea/ bx 20.45.10.10.25 87502QW $95.80

Lab Lead Form

Cepheid GeneXpert Xpress

IA L C

AI W

HbA1c and Glucose

D* E V

Lipid Profile

GeneXpert Xpress ®

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology GeneXpert® Xpress II

GeneXpert® Xpress IV

Innovative Compact Design

Simplified Control and Oversight

Proven Cartridge Technology

Two or four-module configuration saves valuable bench space and reduces the need for multiple testing platforms.

GeneXpert Xpress complements existing laboratory quality and regulatory compliance standards.

With a combination of highly accurate results and operator ® ease-of-use, Cepheid’s cartridge technology remains the cornerstone of the GeneXpert Xpress.

• Scalable Design — Allows for multiple tests to be run simultaneously

• Simple test workflow—No specialized training

• Single use, self-contained cartridge — Reduces contamination

• Random Access — True on-demand walkaway testing system

• Operator authentication and QC lockout

• Integrated QC in every cartridge

• Standardized GeneXpert Technology — One Platform, One Cartridge

• No daily or weekly maintenance

Chemistry

Immunoassay

Specialty

Cepheid C360

• Interfaces to Laboratory Information Systems (HL7, ASTM) • Data monitoring and management with Cepheid® C360^

• Minimal hands on time for each sample — Just add the sample and go!

ESR Blood Gas Coagulation

• Lab quality test results

Cardiac LIS/Resources

* Test system is waived under CLIA ^ Expected availability in 1H 2018

Forms


Lab Portfolio

Cepheid Xpress Flu CEQPRSFLU10CW 10 ea/ bx 20.45.10.10.25 87502QW $95.80

Lab Lead Form

Cepheid GeneXpert Xpress

Sample In. Answer Out.

HbA1c and Glucose

Simple test workflow is easy to use and learn - insert the cartridge and the system does the rest.

Lipid Profile

As simple as 1, 2, 3 — Hands-On Time < 1 minute

2

1 Obtain swab specimen

3

Transfer sample to cartridge

Medline POC

Insert cartridge and start test

Influenza A & B / RSV

Strep

CL

Xpert® Xpress Flu Xpert® Xpress Flu

Additional POC IA

Fast Accurate Diagnosis When it Matters Most. Xpert Xpress Flu test is a qualitative, automated molecular, real-time PCR test providing accurate detection of and differentiation of influenza A and B viral RNA. Positive Percent Agreement

Negative Percent Agreement

Influenza A

98.2%

97.7%

Influenza B

97.8%

99.4%

Quality Results

W AI

VE

D

• Multiplex real-time RT-PCR molecular test results

Urinalysis Hematology

• Sample Types — Nasal Swab, Nasopharyngeal Swab • Test time as soon as 20 minutes*

Chemistry

• Internal QC in each test cartridge • Room temperature reagent storage (2–28°C)

Immunoassay

* Early Assay Termination (EAT) for positive results when high concentrations of virus are present in the specimen. Negative results available in 30 minutes.

Specialty

Xpert® Xpress Strep A

CLIA WAIVED

Xpert® Xpress Strep A – Coming Soon^

Rapid. Quality results. No compromise. Xpert Xpress Strep A changes what is possible with in-office • Confirmatory molecular test results confirmatory Group A Strep results — providing medically • Sample Type – Throat Swab actionable and timely results to clinicians to optimize fast (E-swab in liquid Amies) treatment decisions and support antimicrobial stewardship. • Test time as soon as 18 mins for positives#

ESR Blood Gas Coagulation

• Internal QC in each test cartridge

^ CLIA Waiver is pending FDA Review. Final performance characteristics to be established as part of the FDA review. Expected availability 1H2018. # EAT for positive results when high concentrations of streptococci are present in the specimen. Negative results available in 24 minutes. † No culture confirmation required for negative results unless clinical symptoms persist, or there is an outbreak of acute rheumatic fever (ARF).

• Room temperature reagent storage (2–28°C) • No confirmation required for negative results†

Cardiac LIS/Resources Forms


Lab Portfolio

Cepheid Xpress Flu CEQPRSFLU10CW 10 ea/ bx 20.45.10.10.25 87502QW $95.80

Lab Lead Form

Cepheid GeneXpert Xpress

HbA1c and Glucose

Lipid Profile

GeneXpert® Xpress Specifications Catalog Numbers SYSTEM

DESCRIPTION

CATALOG NUMBER

GeneXpert® Xpress II

2-module configuration

GXII-CLIA-L

GeneXpert® Xpress IV

4-module configuration

GXIV-CLIA-L

Medline POC Influenza A & B / RSV

Dimensions and Weight

Strep

SYSTEM

DESCRIPTION

WIDTH

HEIGHT

DEPTH

WEIGHT

GeneXpert® Xpress II

2-module configuration

6.4"

12.0”

11.7”

15 Ibs

GeneXpert® Xpress IV

4-module configuration

11.1”

12.0”

11.7”

25 Ibs

Additional POC

Urinalysis

Xpert® Xpress Flu

Hematology

Catalog Numbers TEST NAME

DESCRIPTION

CATALOG NUMBER

Xpert® Xpress Flu

10 Tests

XPRSFLU-10

Xpert Nasal Sample Collection Kit (For Viruses)

100 Nasal Swabs & UTM Kits

SWAB/F-100

Xpert® Xpress Flu Nasal 1 StartPAK

60 Tests, 100 Nasal Collection Kits, Flu Organism Panel and Control Bundle

XPRSFLU-NSL1-SPAK

Xpert® Xpress Flu Nasal 2 StartPAK

60 Tests, 100 Nasal Collection Kids and Flu Control Bundle

XPRSFLU-NSL2-SPAK

TEST NAME

DESCRIPTION

CPT CODE

Xpert Xpress Flu

87502-QW Influenza virus, for multiple types or sub-types, includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, first 2 types or sub-types

Chemistry

Immunoassay

Specialty

ESR

CPT Code Information ®

Blood Gas Coagulation

Cardiac LIS/Resources CORPORATE HEADQUARTERS

EUROPEAN HEADQUARTERS

904 Caribbean Drive Sunnyvale, CA 94089 USA

Vira Solelh 81470 Maurens-Scopont France

TOLL FREE

1.888.336.2743 1.408.541.4191 FAX 1.408.541.4192

PHONE

PHONE

FAX

www.Cepheid.com

Forms

33.563.82.53.00 33.563.82.53.01 0688-01


Lab Portfolio S_Flu_ss_ƒ.qxp_Layout 1 10/31/19 12:09 PM Page 1

Sekisui Silaris Flu

Sekisui Silaris Influenza A&B Test OSOM1027 25 ea/bx 20.30.00.11.06 87502QW $95.80

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC

Flu

This single test accurately aids in the diagnosis of Influenza A&B using the trusted performance of PCR technology.

Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Flu Facts INFLUENZA REMAINS A MAJOR THREAT TO

Immunoassay

Specialty

PUBLIC HEALTH. RECENT STUDIES SHOW THAT IN A TYPICAL INFLUENZA SEASON, 5-20% OF THE US POPULATION FALLS ILL

ESR

AND MORE THAN 200,000 ARE HOSPITALIZED. THE MOST SEVERE OUTCOMES OCCUR IN PEOPLE 65 AND OLDER, VERY YOUNG CHILDREN, AND THOSE WITH UNDERLYING

Blood Gas

HEALTH CONDITIONS. 1

Test

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Sekisui Silaris Influenza A&B Test OSOM1027 25 ea/bx 20.30.00.11.06 87502QW $95.80

S_Flu_ss_ƒ.qxp_Layout 1 10/31/19 12:09 PM Page 2

Lab Lead Form

Sekisui Silaris Flu

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

P/N: 50033 Rev:0

✔ Molecular results ✔ State-of-the-art microfluidic cassette technology ✔ Proprietary OscAR technology reduces run time ✔ Sensitivity: Flu A 97%; Flu B 94% ✔ Specificity: Flu A 94%; Flu B 99%

Chemistry

Immunoassay

✔ Single test for diagnosis ✔ Controls in every kit ✔ Molecular reimbursement (CPT Code 87502QW)

Specialty

✔ Easy to use ✔ Nasal swab collection ✔ Compact portable dock with no calibration required ✔ Room temperature storage

Silaris Influenza A&B Test

1027

Silaris Influenza A&B Control Kit

1024

THE AMERICAS

INTERNATIONAL

Sekisui Diagnostics, LLC One Wall Street Burlington, MA 01803 Phone: 800 332 1042 Fax: 800 762 6311 Email: questions@sekisui-dx.com

Sekisui Diagnostics (UK) Limited Liphook Way, Allington Maidstone, Kent, ME16 0LQ, UK Phone: +44 1622 607800 Fax: +44 1622 607801 Email: info@sekisui-dx.com

© 2019 Sekisui Diagnostics, LLC. All rights reserved. Silaris® is a registered trademark of Sekisui Diagnostics, LLC. Because every result matters™ is a trademark of Sekisui Diagnostics, LLC. 1 https://report.nih.gov/nihfactsheets/ViewFactSheet.aspx?csid=133

ESR Blood Gas Coagulation

Cardiac LIS/Resources www.sekisuidiagnostics.com

1674-2 08/19

Forms


Lab Portfolio Sekisui Silaris RSV

Sekisui Silaris RSV Test OSOM1030 25 ea/bx 20.26.31.10.64

Lab Lead Form HbA1c and Glucose

Lipid Profile

RSV This single test accurately aids in the diagnosis of RSV using the trusted performance of PCR technology.

Medline POC Influenza A & B / RSV

Strep Additional POC

Urinalysis Hematology

Chemistry

RSV Facts ALMOST ALL CHILDREN WILL BE INFECTED WITH RSV BY THEIR SECOND BIRTHDAY.

Immunoassay

Specialty

RSV USUALLY CAUSES MILD RESPIRATORY ILLNESS, BUT IT CAN BE SERIOUS, ESPECIALLY IN INFANTS AND OLDER ADULTS.

ESR

IT IS THE MOST COMMON CAUSE OF BRONCHIOLITIS AND PNEUMONIA IN CHILDREN YOUNGER THAN 1 YEAR OF AGE. 1

Blood Gas

Test

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Sekisui Silaris RSV Test OSOM1030 25 ea/bx 20.26.31.10.64

Lab Lead Form

Sekisui Silaris RSV

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC RSV

Urinalysis

BT: 80053 Rev: A

Hematology

P/N: 50048 Rev: A

Chemistry

Immunoassay 87634QW

Specialty

ESR 30 minutes to test results

Blood Gas Silaris RSV Test

1030

Coagulation 1029

Silaris RSV Control Kit

THE AMERICAS

INTERNATIONAL

Sekisui Diagnostics, LLC One Wall Street Burlington, MA 01803 Phone: 800 332 1042 Fax: 800 762 6311 Email: questions@sekisui-dx.com

Sekisui Diagnostics (UK) Limited Liphook Way, Allington Maidstone, Kent, ME16 0LQ, UK Phone: +44 1622 607800 Fax: +44 1622 607801 Email: info@sekisui-dx.com

© 2019 Sekisui Diagnostics, LLC. All rights reserved. Silaris® is a registered trademark of Sekisui Diagnostics, LLC. Because every result matters™ is a trademark of Sekisui Diagnostics, LLC. 1 https://www.cdc.gov/rsv/index.html

Cardiac LIS/Resources www.sekisuidiagnostics.com

80-8545-00-02 08/19

Forms


Lab Portfolio

Alere BinaxNOW RSV OTC430122 22 ea/bx 20.12.42.14.65 87807QW $13.10

Lab Lead Form

Alere BinaxNOW

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

BinaxNOW RSV ®

Urinalysis

The BinaxNOW® assay was sensitive and specific in detecting RSV infections over three consecutive winter seasons. This is reassuring, given the frequency of which clinical decisions are based on these rapid tests.¹ This test performed particularly well in neonates, those children at highest risk for apnea and other severe complications of RSV disease.¹ Features & Benefits     

Specialty

ESR

Benefits of Rapid Diagnosis  Guide appropriate therapy  Avoid unnecessary antibiotic use

To learn more about rapid detection of RSV, contact your local Account Executive.

Chemistry

Immunoassay

Results: 15 minutes Onboard extraction: no extra steps Sample types: nasopharyngeal swab and nasal wash Shelf life: up to 24 months2 One Step: no additional reagents needed

Why test for RSV?  90,000 hospital admissions per year nationally1  Clinically difficult to differentiate RSV from other serious respiratory viruses1

Hematology

Blood Gas Coagulation

Actual size Actual size

Cardiac LIS/Resources Forms


Lab Portfolio

Alere BinaxNOW RSV OTC430122 22 ea/bx 20.12.42.14.65 87807QW $13.10

Lab Lead Form

Alere BinaxNOW

BinaxNOW RSV Comparison Grid ®

HbA1c and Glucose

BinaxNOW® RSV

Quidel QuickVue® RSV

Patented card format

Dipstick

YES

YES

NP Swab Nasal wash

NP swab, NP/Nasal wash NP aspirate

Reagents

0

1

Timed Steps

1

2

Tests per Kit

22

20

Kit Storage

Room temperature

Room temperature

24 months2

24 months

Product Name Format Clia Waived Sample Types

Shelf Life QC Requirements

Once per shipment

3

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Every new operator, each new lot or every shipment (provided that each different lot in the shipment is tested)

Additional POC

Urinalysis

Easy to Use 1 Collect wash or elute swab specimen

2 Add 100 µl to the top, white sample pad

3 Close device and read at 15 minutes

,

4 Interpret Results

Negative

Hematology

Chemistry

Positive Invalid

Immunoassay

Specialty

Order Information You test for one, Why not both?

BinaxNOW® RSV and Influenza A & B 1 Sample 2 Test 3 Results

Call 1.877.441.7440 or visit www.alere.com today

BinaxNOW® RSV CLIA Waived 22 Test Kit Order No. 430-122 CPT: 87807QW CLIA Waived 10 Test Kit Order No. 430-100 CPT: 87807QW Moderately Complex 42 Test Kit Order No. 430-000 CPT: 87807QW NP Swab Accessory Pack Quantity: 22 Swabs, 22 Vials of Elution Solution Order No. 400-065

¹ Andrea T.Cruz,M.D., et al, “Performance of a Rapid Assay (Binax NOW® RSV) for Respiratory Syncytial Virus at a Children’s Hospital over a Three-Year Period”, Journal of Clinical Microbiology (2007 45: 1993-1995). ² From date of manufacture. ³ See package inserts for details. © 2011 Alere. All rights reserved. The Alere Logo, Alere and BinaxNOW are trademarks of the Alere group of companies. All other trademarks referenced are trademarks of their respective owners. PN: 12000292-01 9/11

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Quidel QuickVue RSV QDL20193 20 ea/bx 20.12.25.14.93 87807QW $13.10

Lab Lead Form

Quidel QuickVue RSV

HbA1c and Glucose

Lipid Profile

Medline POC

Quick, easy, accurate! Diagnosing and managing respiratory syncytial virus (RSV) is serious business. In the U.S., RSV is estimated to be responsible for 73,400 to 126,300 hospitalizations annually for bronchiolitis and pneumonia alone among children younger than one year.1 In children hospitalized with an RSV infection, it is believed to be the most common viral cause of death in children younger than five years, particularly in children younger than one year.2

Due to potentially serious complications that may result from RSV, prompt detection and management are critical. The QuickVue RSV test is a simple and accurate test that can aid in diagnosing RSV quickly and confidently, giving the results you need. Right. Now.

Influenza A & B / RSV Strep

Additional POC

Urinalysis Hematology

Chemistry Rapid Diagnosis and Treatment • Results in 15 minutes or less. Accurate Detection • Accurate detection with choice of sample type: • 99% sensitivity with nasopharyngeal aspirate. • 92% sensitivity with nasopharyngeal swab. • 83% sensitivity with nasal/nasopharyngeal wash. Easy to Use • CLIA waived. • Dipstick test format. • 3-step procedure, approx. 30 seconds hands-on time. • Only 1 reagent. • Two-color endpoint for easy to read and interpret results.

Advantages of QuickVue RSV • High sensitivity and specificity (see back for performance details). • Each kit contains everything needed to perform the test, including nasopharyngeal swabs and Positive and Negative Controls. • Room temperature storage with up to 24-month shelf life from date of manufacture. • Cleared for use with children up to 18 years of age. • When run in conjunction with a QuickVue Influenza test, a single specimen sample may be used for both tests, eliminating the need to collect multiple samples, causing less patient discomfort while saving valuable time. • Synagis does not interfere with the QuickVue RSV test.

Collins P., Chanock R., Murphy B. Fields Virology. Fourth Edition. Volume 1. Chapter 45 - Respiratory Syncytial Virus. Lippincot Williams and Wilkins. (2001). Thompson W. et al. Mortality Associated With Influenza and Respiratory Syncytial Virus in the United States. JAMA, January 8, 2003 - Vol 289, No. 2.

Immunoassay

Specialty

ESR Blood Gas

1 2

For more information on QuickVue RSV test kits, visit our website or call your Quidel Account Manager at 1.800.874.1517 (U.S. only) or 858.552.1100 (outside U.S.). Quidel Corporation • Worldwide Headquarters • 10165 McKellar Court • San Diego, CA 92121 USA • www.quidel.com

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Quidel QuickVue RSV QDL20193 20 ea/bx 20.12.25.14.93 87807QW $13.10

Lab Lead Form

Quidel QuickVue RSV

HbA1c and Glucose

Nasopharyngeal aspirate and Nasal/Nasopharyngeal wash procedure:

Lipid Profile

Medline POC Influenza A & B / RSV Nasopharyngeal Aspirate: Sensitivity: 99% Nasal/Nasopharyngeal Wash: Sensitivity: 83%

Specificity: 92%

Accuracy: 94%

Specificity: 90%

Accuracy: 87%

Nasopharyngeal swab procedure:

Strep

Additional POC

Results:

Urinalysis Hematology

Chemistry Any shade of pink is considered positive.

Nasopharyngeal Swab: Sensitivity: 92%

Specificity: 92%

Accuracy: 92%

Immunoassay

The performance of any rapid RSV test is dependent on sample collection and handling and the adherence to the Package Insert. Refer to our website at www.quidel.com for additional performance claims.

Specialty

ESR

To order: Call your Quidel Account Manager at 1.800.874.1517 QuickVue RSV – 20 Test Kit: Catalog #20193

Blood Gas

For more information on QuickVue RSV test kits, visit our website or call your Quidel Account Manager at 1.800.874.1517 (U.S. only) or 858.552.1100 (outside U.S.).

Coagulation

Quidel Corporation • Worldwide Headquarters • 10165 McKellar Court • San Diego, CA 92121 USA • www.quidel.com

Cardiac

Distributor Information:

LIS/Resources SL1801

0993ID0606D-7 (08/09)

Forms


Lab Portfolio

Quidel Sofia RSV QDL20260 (RSV) 25 ea/bx L20.11.91.3.51 87807QW $13.10

Placement Agreement

Quidel Sofia 2 RSV

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC

The ART of RSV Testing Secure, remote instrument management through the Virena ecosystem

Accurate, objective and automated results in as few as 3 minutes Excellent performance compared to molecular and viral culture methods

Integrated data management automatically stores test and user history

Flexible, dual mode testing and simple, CLIA-waived procedures for a variety of laboratory environments

User and patient ID captured with onboard barcode scanner

Sofia 2 with Advance Result Technology Delivering accurate, objective and automated results in as few as three minutes!

≥ ART 3mins Advance Result Technology

Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources

Quidel

l Rapid Diagnostics

l quidel.com

l 800.874.1517

l 858.552.1100

Forms


Lab Portfolio

Quidel Sofia RSV QDL20260 (RSV) 25 ea/bx L20.11.91.3.51 87807QW $13.10

Quidel Sofia 2 RSV

Lab Lead Form

Sofia RSV FIA – Procedures

HbA1c and Glucose

Nasopharyngeal Swab Procedure

OR

Nasopharyngeal Aspirate/Wash Procedure

Lipid Profile

Medline POC Influenza A & B / RSV

Sofia 2 Development Modes

Strep

WALK AWAY Mode – Walk away and multitask

READ NOW Mode – Batch multiple samples per hour

Additional POC

15

3-15mins

Urinalysis Hematology

Sofia RSV FIA

Sofia RSV FIA Results vs. Culture*

Accurate detection with nasopharyngeal swabs, or aspirate/wash samples CLIA waived for children less than 7 years of age Moderately complex for pediatric patients 7 to less than 19 years of age Excellent performance demonstrated in a multisite study* Room temperature storage 24-month shelf life from date of manufacture

Patients ages 0-<19 years

Patients ages 0-<7 years

(CLIA Waiver Studies)

Samples

Sens

Spec

Sens

Spec

NPS

86%

97%

87%

96%

NPA/W

89%

98%

92%

98%

NPS – VTM

87%

97%

NPA/W – VTM

88%

98%

Chemistry

Immunoassay

Specialty

ESR

*Refer to the Package Insert for additional performance claims.

Blood Gas Coagulation

Cardiac

SL1801 l SS2026001EN00 (04/17)

Sofia RSV FIA – 25 Test Kit: Catalog #20260

CLIA

WAIVED

LIS/Resources Forms


Lab Portfolio

BD Veritor BDD256038 (RSV) 30 ea/bx G20.11.67.3.68 87807QW $13.10

Lab Lead Form

BD Veritor RSV

HbA1c and Glucose

Now in the clinical lab

BD Veritor System analyzes... ™

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

...All that you see

and all that you can’t.

Hematology

Chemistry

Immunoassay

Specialty

ESR

For Rapid Detection of RSV* For Rapid Detection of Flu A+B • Technology-verified Performance – Incorporates state of the art

technologies that deliver results For Rapid Detection of Group A you can trust

• Multiple Sample Types – Validated to be used with nasopharyngeal washes/aspirates, and nasopharyngeal swabs in transport

*Respiratory Syncytial Virus

Blood Gas • Convenient Kit Configuration– Fully customized kit to test and deliver results in minutes STREP • Objective Results – Easy to read digital display eliminates subjective interpretation

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

BD Veritor BDD256038 (RSV) 30 ea/bx G20.11.67.3.68 87807QW $13.10

Lab Lead Form

BD Veritor RSV

HbA1c and Glucose

When RSV is suspected…

Detect. Analyze. Verify.

Lipid Profile

Medline POC

BD Veritor™ System – Proven Performance Clinical Performance — BD Veritor RSV to Viral Cell Culture NPS Viral Cell Culture

Clinical Performance — BD Veritor RSV to Viral Cell Culture NPWA Viral Cell Culture

P

N

BD Veritor RSV

P

P

153

9*

162

P

152

15**

167

N

20

524

544

N

14

259

273

173

533

706

166

274

440

BD Veritor RSV

N

Influenza A & B / RSV

Strep

Additional POC

Sensitivity: 152/166 = 91.6% Specificity: 259/274 = 94.5%

Sensitivity: 153/173 = 88.4% Specificity: 524/533 = 98.3%

*Of the 9 BD Veritor RSV Positive, Viral Cell Culture negative specimens, **Of the 15 BD Veritor RSV Positive, Viral Cell Culture negative specimens, 6 were positive by FDA cleared Prodesse® ProFlu™+ molecular assay 8 were positive by FDA cleared Prodesse® ProFlu™+ molecular assay (Data from package insert) (Data from package insert)

State of the Art Technologies • Advanced Particle Technology enhances sensitivity, helping to improve test performance • Adaptive Read Technology helps improve specificity to reduce false positive results

Convenient Workflow Delivers Results in Minutes

Urinalysis Hematology

Chemistry

Immunoassay

Specialty Easy sample processing Prefilled unitized tube facilitates workflow

Ready in minutes Test device is ready to insert into reader 10 minutes after sample is added

Ordering Information

Insert and read Simple one-touch button readies the reader for test device insertion

Objective results Once the test device is inserted in the reader, an objective, digital test result is displayed in 10 seconds

ESR Blood Gas Coagulation

Description BD Veritor™ System Reader

Cat. No. Qty.

Description

Cat. No. Qty.

256055

BD Veritor™ System RSV Kit

256042

1

30

BD Diagnostics 7 Loveton Circle Sparks, MD 21152-0999 www.bd.com/ds

Changing the Way You View Rapid Testing

BD, BD Logo and BD Veritor are trademarks of Becton, Dickinson and Company ©2012 BD 223560 September 2012 Printed in USA

www.bd.com/ds/veritorsystem

Prodesse and ProFlu are trademarks of Hologic Gen-Probe Incorporated

Cardiac LIS/Resources Forms


Lab Portfolio

ID NOW RSV ALR435000 24 ea/bx L20.37.08.2.44 87634QW $77.99

Lab Lead Form

ID NOW RSV

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology MOLECUL AR. IN MINUTES.™

ID NOW RSV ™

The fastest RSV results when it matters most

nn

Actionable results in 13 minutes or less

nn

25% more true positives than RADTs1,2

nn

Room temperature storage

nn

CLIA waived

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

ID NOW RSV ALR435000 24 ea/bx L20.37.08.2.44 87634QW $77.99

Lab Lead Form

ID NOW RSV

ID NOW RSV

HbA1c and Glucose

SPEED – THE FASTEST MOLECULAR RSV TEST FOR EXPEDITING WORKFLOW

Lipid Profile

ID NOW IS 2 MINUTES FASTER

Medline POC

ID NOW IS 7 MINUTES FASTER

Influenza A & B / RSV

13

15

MINS

20

MINS

Strep

MINS

Additional POC ID NOW RSV

Other Rapid Molecular

RADTs

Urinalysis

PERFORMANCE – SUPERIOR SENSITIVITY ENHANCES CLINICAL CONFIDENCE n Detects up to 25% more true positives

RADTs1 SENSITIVITY

than RADTs1,2

74%

n Reduces unnecessary antibiotic usage

Hematology

n Optimizes infection control

Chemistry

ID NOW RSV VS. PCR2 READER TECHNOLOGY 1* SENSITIVITY

76-77%

ID NOW RSV 2 SENSITIVITY

0%

Direct Swab

98.6%

Specificity

98.0%

VTM

98% PCR used as reference method | *BD Veritor™: 76%, Quidel Sofia®: 77%

Sensitivity

100%

EASE OF USE - SIMPLIFYING THE TEST PROCESS

Sensitivity

98.6%

Specificity

97.8%

ORDER INFORMATION PRODUCT NAME

n CLIA waived nasopharyngeal swabs, for both Direct and eluted in VTM

ID NOW RSV 24 TEST KIT

435-000

ID NOW RSV CONTROL SWAB KIT

435-080

n Standardized respiratory trio (Influenza A & B, RSV, Strep A) across all sites of care n Bi-directional connectivity to industry leading RALS® platform facilitates satellite

Specialty

ESR

n Room temperature storage eliminates need for refrigeration n Integrated pipette eliminates manual pipetting for direct samples

Immunoassay

CPT® CODE: 87634 - QW

PRODUCT CODE

Blood Gas Coagulation

testing and remote management

Cardiac FOR MORE INFORMATION, CONTACT YOUR LOCAL ABBOTT REPRESENTATIVE OR VISIT ALERE.COM. 1. Chartrand, C. et al. Diagnostic Accuracy of Rapid Antigen Detection Tests for Respiratory Syncytial Virus Infection: Systematic Review and Meta-analysis. J Clin Microbiol. December 2015 vol. 53 no. 12 3738-3749 2. ID NOW RSV Product Insert © 2019 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. IDDM182009 120004454-03 01/19

LIS/Resources Forms


Lab Portfolio Roche Liat Molecular RSV

Roche Cobas Liat Flu/ RSV BID8160104190 20 ea/bx L20.74.15.21.92 87631QW $142.63

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

odds are it’s RSV.

Additional POC

Urinalysis Hematology

Chemistry

New test uses one sample to give three results in 20 minutes – Influenza A, Influenza B and RSV.

Immunoassay

Specialty

ESR

Make the right treatment decisions right away. Quick and accurate diagnosis can greatly benefit patients who contract respiratory syncytial virus (RSV). With the cobas® Liat® PCR System, you can count on quick, accurate results in just three simple steps — so you can provide optimal treatment faster.

One sample. Three results. Test for Influenza A, Influenza B and RSV with one sample. No age restrictions. A fast diagnosis is critical both for infants and elderly patients. CLIA-waived. A real-time PCR system that is CLIAwaived and delivers results in 20 minutes.

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Roche Cobas Liat Flu/ RSV BID8160104190 20 ea/bx L20.74.15.21.92 87631QW $142.63

Placement Agreement

Roche Liat Molecular RSV

Lab Lead Form HbA1c and Glucose

The cobas Liat advantages are clear. ®

®

cobas Liat

Alere™i

Rapid Antigen Testing

Lipid Profile

Medline POC

1. Test in any setting 2. Molecular testing 3. Real-time PCR

5. One test, three results (Influenza A, Influenza B and RSV)

6. Walk-away workflow

7. Closed system

4. CLIA-waived for Influenza A/B, Influenza A/B and RSV, and Strep A

Influenza A & B / RSV

Strep

Additional POC

Cut steps. Speed up treatment.

7

Steps

3

Steps

Urinalysis

Alere™i testing method *Influenza A/B and RSV are separate tests. The test type must be confirmed within 10 minutes after inserting the test base; and the test must be started within 10 minutes after inserting the sample receiver. Otherwise, the instrument will time out and all test pieces must be removed and discarded.

1

2

3

Open lid.

Insert orange test base.

Insert blue sample receiver and warm up.

4

5

Collect Connect white sample and cartridge to blue mix it in blue sample receiver. sample receiver.

6

7

Place white cartridge on top of orange test base.

Start test.

cobas Liat System protocol: Just test and walk away

1

2

3

Collect sample and add to assay tube.

Scan assay tube and sample.

Insert assay tube to start test.

Fewer steps. Faster treatment. Lab-quality results.

Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Save time when your patients need it most with the cobas Liat System. To learn more, visit: go.roche.com/pcrtest

Cardiac

© 2017 Roche Diagnostics, North America. All rights reserved. Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 1-800-852-8766

1All negative test results should be confirmed by bacterial culture because negative results do no preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment. (From the Alere i Strep A package insert.)

LIS/Resources Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

Strep Medline Step A Casette

Lipid Profile

Medline POC

ID NOW Strep

Roche® Liat® Molecular Strep A

Influenza A & B / RSV

Sofia 2 Strep A SS2027410EN00.qxp_Layout 1 11/10/17 3:03 PM Page 1

Group A Strep Test Fast results. Immediate care. The Medline Strep A Test provides a high-performance, easy-to-use Strep A test for use in CLIA-waived labs. This highly sensitive test qualitatively detects the presence of Strep A antigen in a throat swab, delivering rapid results.

ID NOW STREP A 2 ™

• 1 minute hands-on time • Simple and accurate

Now the fastest Strep A test without the need for culture confirmation.

• Reimbursable

Benefits of Rapid Diagnosis1

• Guides appropriate therapy • Helps avoid unnecessary antibiotic use

• Empowers timely treatment decisions

Performance

nn

The fastest Strep A test – positive results in as few as 2 minutes 1

100

97.0%

95.0%

95.0%

nn

Enhanced molecular sensitivity eliminates

60

the need for culture confirmation of

40

negative results 2

20 0

nn Sensitivity

Specificity

Objective Strep A Results at Your Fingertips

MOLECUL AR. IN MINUTES.™

Features of the Strep A Test

• Results in 5 minutes

80

Strep

you might have strep.

Point-of-Care testing accelerates care.

Nearly 90% fewer false negatives than RADTs †, 2, 3

Overall Accuracy

nn

CLIA waived

2

The only real-time PCR test that's CLIA-waived for Influenza A/B, RSV and Strep A in 20 minutes or less.

Accurate, objective and automated results in 5 minutes

Secure, remote instrument management through the Virena ecosystem

Excellent performance compared to molecular and bacterial culture methods

Integrated data management automatically stores test and user history

Flexible, dual mode testing and simple, CLIA-waived procedures for a variety of laboratory environments

User and patient ID captured with onboard barcode scanner

Additional POC

+

No confirmation needed at the time of visit. With the cobas® Liat® System, zero “Strep A” patients need confirmation at the time of visit, compared to 90% of patients tested with Alere™i. Data based on a theoretical population of 1,000 patients and 10% prevalence of strep throat in the community.

VS.

Urinalysis

Alere™i With the Alere™i system, 900 out of 1,000 patients with negative test results should have their results confirmed.1

Quidel

l Rapid Diagnostics

l quidel.com

l 800.874.1517

l 858.552.1100

Hematology Cepheid Strep A

Chemistry

Xpert® Xpress Strep A Rapid, Quality Results. No Compromise.

Immunoassay Now you can have it all.

Specialty For In Vitro Diagnostic Use.

A better way.

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Medline Strep A Cassette MPH30025SA 25 ea/bx 20.1.22.22.95 87880QW $16.53

Lab Lead Form

Medline Strep A

Group A Strep Test

Point-of-Care testing accelerates care.

HbA1c and Glucose

Lipid Profile

Medline POC

Fast results. Immediate care.

Influenza A & B / RSV

The Medline Strep A Test provides a high-performance, easy-to-use Strep A test for use in CLIA-waived labs. This highly sensitive test qualitatively detects the presence of Strep A antigen in a throat swab, delivering rapid results.

Strep Additional POC

Urinalysis Hematology

Features of the Strep A Test

• Results in 5 minutes

• 1 minute hands-on time

Chemistry

• Simple and accurate • Reimbursable

Benefits of Rapid Diagnosis1

Immunoassay

• Guides appropriate therapy • Helps avoid unnecessary antibiotic use

Specialty

• Empowers timely treatment decisions

ESR

Performance Blood Gas

100 80

97.0%

95.0%

95.0%

60

Coagulation

40 20 0

Sensitivity

Specificity

Overall Accuracy

Cardiac LIS/Resources Forms


Lab Portfolio

Medline Strep A Cassette MPH30025SA 25 ea/bx 20.1.22.22.95 87880QW $16.53

Lab Lead Form

Medline Strep A

HbA1c and Glucose

Strep A Test. Fast results accelerate treatment. Easy to Read

Easy to Use A

Lipid Profile

B

Medline POC

Positive MAX

1 minute

1 Add four drops each of Reagent A and Reagent B to extraction tube.

2 Place the swab in the tube, rotate 10 times and leave in the tube for one minute.

Test

Influenza A & B / RSV

Control

M

T C

M

T C

Strep

Negative M

Additional POC T C

MEDLINE STREP A MEDLINE STREP A

Invalid

Urinalysis

M

T C

M

T C

CC

Hematology

TT

5 minutes

3 Squeeze the tube around the swab head to expel all the liquid. Remove the swab from the tube.

Chemistry

4 Insert test strip. Wait 5 minutes and then read the result.

Immunoassay

Specialty Medline is the solution for all your point-ofcare needs

As a leading provider of quality medical supplies, Medline offers a broad array of rapid, point-of-care tests, as well as other diagnostic equipment to help diagnose, treat and monitor your patients quickly and efficiently.

ESR Blood Gas

Ordering Information Item No.

Description

Pkg.

MPH30025SA

Medline Strep A Test Strip

25/bx

Learn more. Contact your Medline Representative, call 1-800-MEDLINE or visit medline.com. REFERENCE: 1 Sheeler RD, Houston MS, Radke S, et al. Accuracy of Rapid Strep Testing in Patients Who Have Had Recent Streptococcal Pharyngitis. J Am Board Fam Med. 2002;15(4). Available at: http://www.medscape.com/viewarticle/440096_1 Accessed October 8, 2015.

Coagulation

Cardiac LIS/Resources

© 2020 Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc. MKT19W669948 / LIT561R / 2.5M / SG / 57

Forms


Lab Portfolio

Alere ID NOW Strep ALRI734000 24 ea/bx L20.27.08.1.14 87651QW $35.09

Placement Agreement

ID NOW Strep

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis MOLECUL AR. IN MINUTES.™

ID NOW STREP A 2

Hematology

Now the fastest Strep A test without the need for culture confirmation. nn

The fastest Strep A test – positive results in as few as 2 minutes 1

nn

Enhanced molecular sensitivity eliminates the need for culture confirmation of negative results 2

nn

Immunoassay

Specialty

ESR Blood Gas Coagulation

Nearly 90% fewer false negatives than RADTs †, 2, 3

nn

Chemistry

Cardiac

CLIA waived2 LIS/Resources Forms


Lab Portfolio

Alere ID NOW Strep ALRI734000 24 ea/bx L20.27.08.1.14 87651QW $35.09

Placement Agreement

ID NOW Strep

Lab Lead Form HbA1c and Glucose

ID NOW Strep A 2 ™

Lipid Profile

SPEED – THE FASTEST STREP A TEST FOR EXPEDITING WORKFLOW

5X

ID NOW IS UP TO 5X FASTER

Positive results detected in as few as 2 minutes, with 99% detected within 3 minutes

n

20X

ID NOW IS UP TO 20X FASTER

1

Negative results in 6 minutes

n

2

6-11

15-40

ID NOW STREP A

RADTs

Other Rapid Molecular

MINS

MINS

MINS

2

n

85.6%

ID NOW STREP A 2 SENSITIVITY

n 100%

RADTs3 SPECIFICITY ID NOW STREP A SPECIFICITY

Hematology Eliminates need for culture confirmation of negative results 2

98.5%

80%

Reduces unnecessary antibiotic usage

80%

Chemistry

Immunoassay

95.4% 2

Additional POC

Urinalysis

PERFORMANCE – SUPERIOR SENSITIVITY ENHANCES CLINICAL CONFIDENCE RADTs3 SENSITIVITY

Influenza A & B / RSV

Strep

No incubation time or thermocycling required

n

2-6

Medline POC

Specialty

93.4% ESR

100%

EASE OF USE - SIMPLIFYING THE TEST PROCESS

ORDER INFORMATION

n Room temperature storage

PRODUCT NAME

n CLIA waived for throat swab

ID NOW™ STREP A 2 - 24 TEST KIT

734-000

ID NOW™ STREP A 2 CONTROL SWAB KIT

734-080

n Integrated pipette eliminates manual pipetting n Standardized respiratory trio (Influenza A & B, RSV, Strep A) across all sites of care n Bi-directional connectivity to industry leading RALS® platform facilitates satellite

PRODUCT CODE

Blood Gas Coagulation

CPT® CODE: 87651-QW

testing and remote management

Cardiac

FOR MORE INFORMATION, CONTACT YOUR LOCAL ABBOTT REPRESENTATIVE OR VISIT ALERE.COM. 1. ID NOW™ Strep A 2 clinical trial data, held on file 2. ID NOW™ Strep A 2 Product Insert 3. Cohen JF, et al. Rapid antigen detection test for group A streptococcus in children with pharyngitis (Review). Cochrane Database of Systematic Reviews. 2016, Issue 7 †Based on the reported sensitivities of RADTs and Alere i Strep A 2. © 2018 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. Any photos displayed are for illustrative purposes only. Any person depicted in such photos is a model. 120004453-04 12/18

LIS/Resources Forms


Lab Portfolio Roche Liat Molecular Strep A

Roche Liat Strep BID7341911190 20 ea/bx L20.32.61.17.53 87651QW $35.09

Placement Agreement

Lab Lead Form HbA1c and Glucose

you might have strep.

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

The only real-time PCR test that's CLIA-waived for Influenza A/B, RSV and Strep A in 20 minutes or less.

Chemistry

Immunoassay

Specialty

ESR

No confirmation needed at the time of visit. With the cobas® Liat® System, zero “Strep A” patients need confirmation at the time of visit, compared to 90% of patients tested with Alere™i. Data based on a theoretical population of 1,000 patients and 10% prevalence of strep throat in the community.

Blood Gas

VS.

Coagulation

Alere™i With the Alere™i system, 900 out of 1,000 patients with negative test results should have their results confirmed.1

Cardiac LIS/Resources Forms


Lab Portfolio

Roche Liat Strep BID7341911190 20 ea/bx L20.32.61.17.53 87651QW $35.09

Placement Agreement

Roche Liat Molecular Strep A

Lab Lead Form HbA1c and Glucose

The cobas® Liat® advantages are clear. Liat®

Lipid Profile Alere™i

Rapid Antigen Testing

1. Test in any setting

Medline POC

2. Molecular testing

3. Real-time PCR

4. CLIA-waived RSV assay

5. No Strep A confirmation of negative results at time of visit

6. Walk-away workflow

7. Closed system

Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Cut steps. Speed up treatment.

7

Steps

3

Steps

Alere™i testing method

Hematology

*The test must be confirmed within 10 minutes. Otherwise, the instrument will time out, and the test base must be discarded.

1

2

3

4

5

6

7

Open lid.

Insert orange test base.

Insert blue sample receiver and warm up.

Collect sample and mix it in blue sample receiver.

Connect white cartridge to blue sample receiver.

Place white cartridge on top of orange test base.

Start test and confirm it within 10 minutes.*

cobas ® Liat ® protocol: Just test and walk away.

1

2

3

Collect sample and add to assay tube.

Scan assay tube and sample.

Insert assay tube to start test.

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Fewer steps. Faster treatment. Lab-quality results. Save time when your patients need it most with the cobas® Liat® System. To learn more, visit us at: go.roche.com/PCRTest

Cardiac

© 2016 Roche Diagnostics, North America. All rights reserved. Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 1-800-852-8766 All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment. (From the Alere™i Strep A package insert.) 1All negative test results should be confirmed by bacterial culture because negative results do no preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment. (From the Alere i Strep A package insert.)

1

LIS/Resources Forms


Lab Portfolio SS2027410EN00.qxp_Layout 1 Sofia 2 Strep A

Quidel Sofia Strep A FIA QDL20274 (STREP) 25 ea/bx L20.4.20.4.14 87880QW $16.53

Placement Agreement

11/10/17 3:03 PM Page 1

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC

Objective Strep A Results at Your Fingertips Accurate, objective and automated results in 5 minutes

Secure, remote instrument management through the Virena ecosystem

Excellent performance compared to molecular and bacterial culture methods

Integrated data management automatically stores test and user history

Flexible, dual mode testing and simple, CLIA-waived procedures for a variety of laboratory environments

User and patient ID captured with onboard barcode scanner

Influenza A & B / RSV Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty +

ESR Blood Gas Coagulation

Cardiac LIS/Resources Quidel

l Rapid Diagnostics

l quidel.com

l 800.874.1517

l 858.552.1100

Forms


Lab Portfolio

Quidel Sofia Strep A FIA QDL20274 (STREP) 25 ea/bx L20.4.20.4.14 87880QW $16.53

SS2027410EN00.qxp_Layout 1 11/10/17 3:04 PM Page 2

Placement Agreement

Sofia 2 Strep A

Lab Lead Form HbA1c and Glucose

Sofia Strep A+ FIA – Procedures Throat Swab Procedure

Lipid Profile Squeeze Top Bulb 120 µL

Medline POC

Pipette

Influenza A & B / RSV

Fill to Line

Strep

Sofia 2 Development Modes WALK AWAY Mode – Walk away and multitask

READ NOW Mode – Batch multiple samples per hour

Additional POC

5

5

Urinalysis ST P RE A ST P RE A ST P RE A

ST P RE

P

P

E

E

R ST

R ST

A

A

A

ST P RE A ST P RE A

Hematology

Sofia Strep A+ FIA Results vs. Culture*

Sofia Strep A+ FIA CLIA waived

Culture

Accurate detection with throat swab samples

Pos

Neg

Sensitivity

93.7% (164/175)

Specificity

94.4% (638/676)

Excellent performance demonstrated in a multi-site study*

Sofia Pos

164

38**

Sofia Neg

11***

638

Compatible with viral transport media

Total

175

676

Room temperature storage 24-month shelf life from date of manufacture

Chemistry

**Of the 38 discordant specimens, 24 of these specimens were positive for GAS when tested with an FDA-cleared molecular device, 14 were negative.

Immunoassay

Specialty

***Of the 11 discordant specimens, 3 were negative when tested with an FDA-cleared molecular device, 8 were positive.

*Refer to the Package Insert for additional performance claims.

ESR Blood Gas Coagulation

Cardiac SL8024 l SS2027410EN00 (11/17)

Sofia Strep A+ FIA – 25 Test Kit: Catalog #20274

CLIA

WAIVED

LIS/Resources Forms


Lab Portfolio

Cepheid Strep A CEQXSTREP10CW 10 ea/bx L20.26.00.2.64 87651QW $35.09

Lab Lead Form

Cepheid Strep A

HbA1c and Glucose

Lipid Profile

Xpert Xpress Strep A ®

Rapid, Quality Results. No Compromise.

Medline POC Influenza A & B / RSV

Strep Additional POC

Urinalysis Hematology

Chemistry

Now you can have it all.

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources For In Vitro Diagnostic Use.

A better way.

Forms


Lab Portfolio

Cepheid Strep A CEQXSTREP10CW 10 ea/bx L20.26.00.2.64 87651QW $35.09

Lab Lead Form

Cepheid Strep A

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Xpert® Xpress Strep A

Xpert® Xpress Strep A

Strep Additional POC

Urinalysis

The Need

The Solution

Accurately diagnose pharyngitis caused by Group A Streptococcus (GAS).

• Cepheid provides on-demand testing for Group A Strep in as soon as 18 minutes.*

• Annually, 616 million people have GAS pharyngitis, more than 18.1 million people develop severe GAS disease and more than 517,000 people die due to severe GAS disease.1

• Careful selection of the target gene produces quality results.

Reduce overuse of antibiotics for the treatment of pharyngitis

• Delivering accurate and timely results optimizes fast treatment decisions and eliminates the need to perform culture confirmation of negative results.

• Based on recent literature 37% of children presenting with pharyngitis tested positive for GAS, however 56% of visits were associated with antibiotic prescriptions. Similarly, 18% of adults presenting with pharyngitis caused by GAS, but 72% were treated with antibiotics.2

The Impact • Accurate diagnosis of GAS supports antimicrobial stewardship and may reduce the amount of patients inappropriately prescribed antibiotics. • Gain testing efficiencies and reduce costs by eliminating culture confirmation testing.3

Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac

• Reduce the risk of GAS complications such as rheumatic fever and glomerulonephritis. • Improve patient satisfaction with quicker time to result and appropriate prescriptions. *

With Early Assay Termination for positive results. Refer to Package Insert Xpert Xpress Strep A 301-6574 Rev. A.

LIS/Resources Forms


Lab Portfolio

Cepheid Strep A CEQXSTREP10CW 10 ea/bx L20.26.00.2.64 87651QW $35.09

Lab Lead Form

Cepheid Strep A

HbA1c and Glucose

National guidelines for Pharyngitis recommend antibiotic therapy only for streptococcal pharyngitis.2”

Lipid Profile

The Infectious Disease Society of America further clarifies that, with the rare exception of infection by certain Corynebacterium diphtheriae and Neisseria gonorrhoeae, antimicrobial therapy is of no proven benefit as treatment for acute pharyngitis due to organisms other than Group A Streptococcus.4

Medline POC Influenza A & B / RSV

Strep Additional POC

Impact on Outpatient Pathway Improving Patient Satisfaction

Urinalysis

Xpert® Xpress Strep A provides medically actionable and timely information to clinicians to support improved patient management and antibiotic stewardship. Elapsed (mins)

5 minutes

Cepheid PCR

Specimen collected and sent for testing

24 minutes Xpert PCR with positive results in as soon as 18 minutes*

24-34 minutes Results delivered to clinician/ patient

Strep A Positive

Deliver best treatment and care

Hematology

Chemistry

Immunoassay Patient Pathway

Strep A Negative

Specialty Assess other factors (Viral or order Throat culture for other pathogens)

ESR Blood Gas Coagulation

Cardiac LIS/Resources

*

With Early Assay Termination for positive results. Refer to Package Insert Xpert Xpress Strep A 301-6574 Rev. A.

Forms


Lab Portfolio

Cepheid Strep A CEQXSTREP10CW 10 ea/bx L20.26.00.2.64 87651QW $35.09

Lab Lead Form

Cepheid Strep A

HbA1c and Glucose

Xpert® Xpress Strep A

Lipid Profile

Medline POC Xpert® Xpress Strep A is a qualitative real-time PCR test providing accurate detection of Group A Streptococcus in as soon as 18 minutes*.

Influenza A & B / RSV

Group A Strep Detection in 3 Simple Steps

Strep Additional POC

Urinalysis Hematology

1

2

3

Obtain throat swab specimen

Transfer sample to cartridge

Insert cartridge and start test

Chemistry

True Automation for Group A Strep Testing

Immunoassay

CATALOG NUMBER

Xpert Xpress Strep A

(10 tests)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .XPRSTREPA-10

COLLECTION DEVICES (not included in kit)

Specialty

Can be ordered through your local distributor

Copan E-Swab in liquid Amies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 480C *

With Early Assay Termination for positive results. Refer to Package Insert Xpert Xpress Strep A 301-6574 Rev. A.

ESR

References: 1. The Global Burden of Group A Streptococcal Diseases. Lancet Infect Dis. 2005 Nov; 5(11):685-94. 2. Fleming-Dutra KE, et al. Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011. JAMA. 2016 May 3;315(17):1864-73. 3. Workflow studies conducted by Cepheid Solutions demonstrate that a throat culture confirmation workup costs~ $9.13 per culture. (Average cost includes reagents, labor cost and time). Data on file. 4. Shulman ST, et al. Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis: 2012 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2012 Nov 15;55(10):1279-82.

Blood Gas

For In Vitro Diagnostic Use. CORPORATE HEADQUARTERS

EUROPEAN HEADQUARTERS

904 Caribbean Drive Sunnyvale, CA 94089 USA

Vira Solelh 81470 Maurens-Scopont France

1.888.336.2743 PHONE 1.408.541.4191 FAX 1.408.541.4192

PHONE

TOLL FREE

FAX

www.Cepheid.com

Coagulation

33.563.82.53.00 33.563.82.53.01 0672-01

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

Additional POC Alere Clearview® H. pylori H. pylori

Alere Determine™ HIV

Two-step technology of H. pylori antibodies.

Clearview H. pylori Clearly different The Clearview® H. pylori patented, innovative technology provides a highly sensitive and specific test for H. pylori. • Rapid Response: Two easy steps, with results in 10 minutes. • Simplicity: CLIA waived,* easy-to-use test requires no training. • Reliability: Built-in control ensures accuracy. • Flexibility: Use with multiple sample types — whole blood, serum or plasma.

Clearly better Clearview® H. pylori provides physicians with fast results for early diagnosis. • Allows patient to start therapy sooner. • Reduces the risk of developing more serious illnesses. • Reduces the likelihood of complications.

Take the first step in identifying drug abuse or misuse.

Alere iCup Dx Pro 2 ®

Key features of the HemoCue® Hb 801 System include:

The first and only FDA approved rapid point-of-care test that simultaneously and separately detects HIV-1/2 antibodies and free HIV-1 p24 antigen on a single test strip.

Breaking the HIV Infection Cycle

The first point-of-care HIV-1/2 Ag/Ab test

Identifying HIV infection early, during the most infectious stage offers significant benefits, particularly in high risk populations such as men who have sex with men and injecting drug users.

Alere Determine™ HIV-1/2 Ag/Ab Combo has the ability to detect HIV earlier than conventional antibody only tests.2 This enables health care providers to diagnose HIV infection earlier allowing individuals to seek medical care sooner.

• Rapid detection also helps to get patients into effective care and treatment earlier.

• CLIA-waived for fingerstick whole blood.

• Individuals who are unaware of their infection are 3.5 times more likely to transmit the virus to someone else.1 • By detecting HIV earlier, further transmission can be prevented during this highly infectious stage.

Strep

The HemoCue® Hb 801 System Seamlessly Integrates Point-of-Care Hemoglobin Testing Into Your Workflow

Urine Drug Screening Device

Enables detection of HIV earlier at the point of care.

provides direct detection

Influenza A & B / RSV

Introducing HemoCue’s Newest Hemoglobin Analyzer

Alere Determine HIV-1/2 Ag/Ab Combo

®

Medline POC

HemoCue Hb 801

Reduced size for collateral use

GI Disorders

Clearview ® H. pylori

Alere Toxicology® iCup DX Pro

Lipid Profile

Additional POC

• Large display with intuitive on-screen symbols • Results in under one second • Internal quality control self-test* • Reagent-free cuvettes, improving open-vial stability • Bluetooth wireless capability • No preventative maintenance

Test without tilting. Detect opiates at low cutoff levels (300 ng/mL) and screen for buprenorphine. Product categorized as CLIA-Waived and is for in vitro diagnostic use only.

• Minimal training required. • Test in three easy steps. • Results in just 20 minutes.

The HemoCue® Hb 801 System is Now Available!

• Test using whole blood, serum, or plasma. for Fingerstick Whole Blood

• Proven 99.9% overall clinical sensitivity for all sample types.

*Refer to your local or regulatory agency for any external control requirements

HemoCue America | California, USA | Phone 800.881.1611 | Fax 800.333.7043 web@hemocue.com hemocue.us ©2019 HemoCue America. All rights reserved. MMUS-0323

To learn more contact your local Account Executive 1.877.441.7440 | AlereHIV.com/US

Urinalysis Hematology

HemoCue Glucose 201

OSOM BV Blue

Magellan LeadCare II

HemoCue® Glucose 201 System

®

The easiest way to test for lead

OSOM Trichomonas

RA P ID D IA GN OS T IC S

www.sekisuidiagnostics.com

Accuracy Starts With Us

We switched to LeadCare II and love it! We get results right away and don’t have to contact patients for follow-up.

FOR USE WITH VAGINAL SWABS

®

TEST PROCEDURE / RESULTS

Microcuvette technology means no need to bring analyzer near patients, reducing the risk of spreading infection

POSITIVE

Individually wrapped microcuvettes to avoid contamination and maximize shelf life (vial cuvettes are also available to high-throughput users)

Industry leading 3 year warranty

✔ FAST; Results in 10 minutes or less ✔ OBJECTIVE; Detects the antigen; removes uncertainty associated with live organism instability

✔ COMPREHENSIVE; Detects vaginitis caused by Gardnerella, Bacteroides, Prevotella, and Mobiluncus

Safeguards Patient Testing and Data

Handheld and battery-operated system ideal for mobile settings

✔ ACCURATE; 83% sensitivity vs. culture; 95% agreement with culture and wet mount combined

✔ OBJECTIVE; Instant color change provides clear, easy-to-read results

– Dr. Ben Spitalnick, Pediatrician

Reduced risk of missed hypoglycemia in newborns

Fixed analyzer calibration, means no need to recalibrate

FEATURES:

✔ FAST; <1 minute hands-on time

Precise monitoring for better glycemic control

No clinically significant lot-to-lot variation

FOR USE WITH VAGINAL SWABS

✔ ACCURATE; 92.8% sensitive, 98% specific vs. gram strain

Used for diagnosis and monitoring of diabetes mellitus

Offers Convenience and Efficiency

THE ONLY CLIA-WAIVED RAPID TEST FOR THE DETECTION OF TRICHOMONAS VAGINALIS FEATURES:

Enables Lab Accuracy With Low Risk

Convenient

CLIA-waived, just two drops of blood.

• Patient satisfaction

Saves time

Eliminates the need for post-visit follow up.

Insert swab into pre-filled vial and mix.

✔ WORLD-CLASS TECHNICAL SUPPORT; Staffed with certified medical technologists and skilled professionals

NEGATIVE

COMPARISON OF BV DETECTION METHODS*

Read results. Let stand for 10 MINUTES at room temperature.

BVBLUE®

Amsel Criteria

Ensures the test gets done.

• Reimbursable

• Immediate action

Results in 3 minutes, while the patient waits.

CPT code 83655

®

TEST PROCEDURE / RESULTS

40%

60%

80%

OSOM ® BV B LUE ® TEST OSOM ® BV B LUE ® CONTROL KIT OSOM ® VAGINITIS TRANSPOR T SYSTEM

C ONFI GUR ATI ON

CATALOG NUMBER

800-305-0197

|

LeadCare2.com

|

LeadCare@magellandx.com

DIAGN OSTICS

Sekisui Diagnostics, LLC 31 New York Avenue Framingham, MA 01701 Phone: 800 332 1042 Fax: 800 762 6311 Email: osomrapidtests@sekisuidiagnostics.com ISO 13485:2003 Certified

25 TESTS

183 184

OS OM ® TR I CH OM ON A S R A P I D TE S T TR I CH OM ON A S P OS I TI V E CON TR OL K I T

50 SWAB SETS

185

OS OM ® VA GI N I TI S TR A N S P OR T S Y S TE M

©2012 Sekisui Diagnostics, LLC – All rights reserved.

* Reference: Sha, Beverly E., Chen, Hua Y., Qiong, J. et al., Utility of Amsel Criteria, Nugent Score and Quantitative PCR for Gardnerella vaginalis, Mycoplasma hominis, and Lactobacillus spp. for Diagnosis of Bacterial Vaginosis in Human Immunodeficiency Virus-Infected Women, Journal of Clinical Microbiology, Sept. 2005, p. 4607-12.

DI AG NO S T I C S

BVBLUE® is a registered trademark of Gryphus Diagnostics, LLC. OSOM® and the OSOM Training logo are registered U.S. trademarks of Sekisui Diagnostics, LLC.

MADE IN THE USA

1036-9 07/12

Read results at 10 MINUTES. POSITIVE

Remove swab from test tube.

O RD E RIN G IN FO RM AT IO N

THE AMERICAS

TO LEARN MORE

Let stand 1 MINUTE.

100%

SENSITIVITY

OR DER I NG I NFOR MATI ON

Insert test stick into extracted sample.

Add sample buffer to test tube.

Insert swab and mix.

(37%)

20%

Immunoassay

✔ WORLD-CLASS TECHNICAL SUPPORT; Staffed with certified medical technologists and skilled professionals

(92.8%)

Add 1 drop of Developer Solution to vial and mix.

• Boosts compliance

Parents appreciate a single visit and a simple fingerstick.

Chemistry

Trichomonas Rapid Test

THE ONLY CLIA-WAIVED RAPID TEST FOR BACTERIAL VAGINOSIS

The HemoCue® Glucose 201 system puts labequivalent answers in health professionals’ hands when they’re needed most — at the Point-of-Care. Not only does the unique cuvette technology enable lab accuracy in just three simple steps, but it reduces serious contamination risks.

www.sekisuidiagnostics.com

®

BVBLUE® Test

Test, educate and take action, all in one visit.

Accurate Answers With Full Confidence

RA PID DIA GN OSTICS

®

NEGATIVE

C O N FIG U RAT IO N

CATA L O G N U M B E R

2 5 TE S TS

1 8 1 OR 1 8 1 E ( CE M A R K E D ) 1 8 2 ( CE M A R K E D )

5 0 S WA B S E TS

185

THE AMERICAS

INTERNATIONAL

Sekisui Diagnostics, LLC 31 New York Avenue Framingham, MA 01701 Phone: 800 332 1042 Fax: 800 762 6311 Email: osomrapidtests@sekisuidiagnostics.com ISO 13485:2003 Certified

Sekisui Diagnostics (UK) Limited 50 Gibson Drive Kings Hill, West Malling, Kent, ME19 4AF, UK Phone: +44 (0) 1732 220022 Fax: +44 (0) 1732 220024 Email: info@sekisuidiagnostics.com ISO 9001:2000 Certified, ISO 13485:2003 Certified

OSOM® and the OSOM Training logo are registered U.S. trademarks of Sekisui Diagnostics, LLC. ©2012 Sekisui Diagnostics, LLC – All rights reserved.

Specialty

MADE IN THE USA

1036-9 07/12

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Alere Clearview H. pylori ALR4581505020 30 ea/ bx 20.5.90.25.82 86318QW $18.09

Placement Agreement

Alere Clearview H. pylori

H. pylori

Lab Lead Form

GI Disorders

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Clearview ® H. pylori Two-step technology provides direct detection of H. pylori antibodies.

Clearview® H. pylori Clearly different The Clearview® H. pylori patented, innovative technology provides a highly sensitive and specific test for H. pylori. • Rapid Response: Two easy steps, with results in 10 minutes. • Simplicity: CLIA waived,* easy-to-use test requires no training. • Reliability: Built-in control ensures accuracy. • Flexibility: Use with multiple sample types — whole blood, serum or plasma.

Clearly better Clearview® H. pylori provides physicians with fast results for early diagnosis. • Allows patient to start therapy sooner.

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas

• Reduces the risk of developing more serious illnesses. • Reduces the likelihood of complications.

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Alere Clearview H. pylori ALR4581505020 30 ea/ bx 20.5.90.25.82 86318QW $18.09

Lab Lead Form

Alere Clearview H. pylori

H. pylori

GI Disorders

HbA1c and Glucose

Lipid Profile

Clearview® H. pylori Comparison Grid

Clearview H. pylori 30 Test Kit Order No. 92405 ®

Product Name

Clearview® H. pylori

Quidel QuickVue® H. pylori gII

BC ICON® HP

Format

30 Cassettes

10 or 30 Cassettes

30 Cassettes

Waived: Whole Blood Moderately Complex: Serum or Plasma

Waived: Whole Blood Moderately Complex: Serum or Plasma

Waived: Whole Blood, Moderately Complex: Serum or Plasma

CLIA Status

Sample

CLIA Waived: Whole Blood Moderately Complex: Serum, Plasma

Whole Blood (Fingerstick Whole Blood (Fingerstick Whole Blood (Fingerstick or Venipuncture), or Venipuncture), or Venipuncture), Serum or Plasma Serum or Plasma Serum or Plasma

Sensitivity

88%

90%

95.9%

Specificity

88%

78%

89%

2

1

3

18 months

14 months

18 months

Room Temperature

Room Temperature

Room Temperature

Procedural Steps Shelf Life Storage

Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Clearview® H. pylori Procedure

OR

Buf fer

Buf fer

50µL

Buf fer

Immunoassay

Specialty

Read in 10 minutes

OR

ESR 2 drops Venipuncture whole blood + 1 drop Buffer

50µL Fingerstick whole blood + 1 drop Buffer

2 drops Serum or Plasma + 1 drop Buffer

Positive

Negative

Invalid

Interpret results

Blood Gas

Contact your local Account Executive 877-441-7440 | alere.com

Coagulation Cardiac

Alere North America, Inc. 30 South Keller Road, Suite 100 Orlando, FL 32810

alere.com

*For whole blood specimens. © 2011 Alere. All rights reserved. The Alere Logo, Alere and Clearview are trademarks of the Alere group of companies. All other trademarks referenced are trademarks of their respective owners. 12000279E-01 09/13

LIS/Resources Forms


Lab Portfolio

Alere Toxicology iCup DX Pro DRUG12CUPRODX | 25 ea/bx L20.4.29.12 80305 $12.60

Lab Lead Form

Alere Toxicology iCup DX Pro

HbA1c and Glucose

Lipid Profile Medline POC

Take the first step in identifying drug abuse or misuse.

Alere iCup Dx Pro 2 ®

Urine Drug Screening Device

Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Test without tilting. Detect opiates at low cutoff levels (300 ng/mL) and screen for buprenorphine. Product categorized as CLIA-Waived and is for in vitro diagnostic use only.

Specialty

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio

Alere Toxicology iCup DX Pro DRUG12CUPRODX | 25 ea/bx L20.4.29.12 80305 $12.60

Lab Lead Form

Alere Toxicology iCup DX Pro

Alere iCup® Dx Pro 2 Urine Drug Screening Device

HbA1c and Glucose

Lipid Profile

Features and Benefits nn

nn

nn

Screens for a wide range of drugs: AMP, BAR, BUP, BZO, COC, MET, MTD, OPI300, OXY, THC*

nn

Simple to use, no need to tilt cup to activate test—read results in five minutes

nn

Self-contained cup is ideal for sending preliminary positive specimens to the lab for confirmation

Medline POC

Includes specimen validity test (SVT): CR, OX, SG

Influenza A & B / RSV

Categorized as CLIA-Waived

Test in 3 Easy Steps Cup lid Peel off label Results legend

Strep

1

2

3

Collect specimen Minimum and secure the lid.fill line

Peel label to reveal drug test and specimen validity

Interpret results at 5 minutes.

Minimu

m Uri

ne Lev

el

Temperature strip STEP 1

m Minimu

Urine

Level

Additional POC

STEP 2

Urinalysis

Hematology

STEP 3

5

min

Minimum fill line

Chemistry

Temperature strip PRODUCT PROCEDURE NOTE: Refer to product insert for complete instructions, limitations, and warnings. For professional in vitro diagnostic use only. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug test result, particularly when preliminary positive results are indicated.

Immunoassay

Available configurations Item #

Alere iCup ® Dx Pro with Specimen Validity Test

Packaging

I-DXP-167-02

AMP, BZO, COC, OPI300, OXY, THC (CR, OX, SG)

25 tests per box

I-DXP-177-01

AMP, BUP, BZO, COC, OPI300, OXY, THC (CR, OX, SG)

25 tests per box

I-DXP-2107-01

AMP, BAR, BUP, BZO, COC, MET, MTD, OPI300, OXY, THC (CR, OX, SG)

25 tests per box

* Drug tests: Amphetamine (AMP), Barbiturates (BAR), Buprenorphone (BUP), Benzodiazepines (BZO), Cocaine (COC), Methamphetamine (MET), Methadone (MTD), Opiate (OPI300), Oxycodone (OXY), Marijuana (THC). Specimen validity tests: Creatinine (CR), Oxidants (OX), Specific Gravity (SG).

Specialty

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Products 800.340.4029 | aleretoxicology.com © 2017 Alere. All rights reserved. The Alere Logo, Alere, iCup, and Knowing now matters are trademarks of the Alere group of companies. All other trademarks referenced are trademarks of their respective owners. The Alere iCup Dx Pro 2 is categorized as CLIA-Waived and may be used by laboratories with a CLIA Certificate of Waiver. MKT50450 REV1 2/17

Forms


Lab Portfolio

HemoCue Hemoglobin 801 Microcuvettes HMQ111902 | 200/ea 20.1.47.15.40 85018QW $2.37

Lab Lead Form

HemoCue Hb 801

HbA1c and Glucose

Introducing HemoCue’s Newest Hemoglobin Analyzer

Lipid Profile Medline POC Influenza A & B / RSV

The HemoCue® Hb 801 System Seamlessly Integrates Point-of-Care Hemoglobin Testing Into Your Workflow

Strep

Additional POC POC Additional Urinalysis

Key features of the HemoCue® Hb 801 System include: • Large display with intuitive on-screen symbols • Results in under one second • Internal quality control self-test* • Reagent-free cuvettes, improving open-vial stability • Bluetooth wireless capability • No preventative maintenance

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

The HemoCue® Hb 801 System is Now Available! *Refer to your local or regulatory agency for any external control requirements

Coagulation Cardiac

LIS/Resources HemoCue America | California, USA | Phone 800.881.1611 | Fax 800.333.7043 web@hemocue.com hemocue.us ©2019 HemoCue America. All rights reserved. MMUS-0323

Forms


HemoCue Hemoglobin 201 Microcuvettes Individually wrapped HMQ111715 | 100/ea 20.1.71.17.80 85018QW $2.37

Lab Portfolio

HemoCue Hemoglobin 201 Microcuvettes HMQ111716 | 200/ea 20.1.44.17.76 85018QW $2.37

Lab Lead Form

HemoCue Glucose 201

HbA1c and Glucose

HemoCue® Hb 201+ System

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC POC Additional Urinalysis

The Standard for Uncompromising Accuracy Providing lab accuracy and ease of use, the HemoCue® Hb 201+ system has become a standard in Hb point-of-care testing. Healthcare providers around the world rely on the immediate results so they can make the right decisions when they need them most — right at the point of care. With dedicated support and service as well as unmatched training and education based on 30 years of experience, you can count on HemoCue for the right solutions for all your needs.

Accuracy Starts With Us

Have Confidence in Your Answers at the Point of Care Precise factory calibration against the ICSH reference method Patented microcuvette technology with excellent lot-to-lot reproducibility Built-in selftest

Chemistry

Immunoassay

Blood-based liquid controls available

Get Easy Access to Lab-Quality Accuracy Capillary, venous or arterial whole blood sample Brief training with virtually no maintenance Link result with patient ID for medical record integration Printer interface

To learn more about the HemoCue® Hb 201+ system, please scan the QR code with your smartphone or visit hemocue.com

Hematology

Specialty

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


HemoCue Hemoglobin 201 Microcuvettes Individually wrapped HMQ111715 | 100/ea 20.1.71.17.80 85018QW $2.37

Lab Portfolio

Lab Lead Form

HemoCue Glucose 201

HbA1c and Glucose

HemoCue Hb 201 System ®

Calibration

+

Modified azidemethemoglobin reaction; dual wavelengths (570 nm and 880 nm) for compensation of turbidity Factory calibrated against the ICSH reference method; needs no further calibration

Sample Material

Capillary, venous or arterial whole blood

Measurement Range

0–25.6 g/dL (0–256 g/L, 0–15.9 mmol/L)

Results

Within 60 seconds

Sample Volume

~10 µL

Dimensions

160 × 43 × 85 mm (6.30 × 1 .69 × 3.35 inches)

25

Medline POC

20

15

Influenza A & B / RSV

10

5

Strep

0 0

5

10

15

20

25

All Comparison Method Results, ICSH (A 540–A700)

Weight

350 g (0.77 pounds) with batteries installed

Storage Temp.

Analyzer: 0–50 °C (32–122 °F) Microcuvettes: unopened 15–30 °C (59–86 °F); three-month open vial stability

Additional POC POC Additional

Operating Temp.

15–30 °C (59–86 °F)

Power

AC Adapter or 4 AA batteries

Interface

Printer and HemoCue® Basic Connect™ including optional barcode scanner

Quality Control

Built-in selftest ; optional liquid controls

CPT Code

85018

Urinalysis

Hematology Chemistry

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Product Item Number

Lipid Profile

HemoCue® Hb 201 vs ICSH Hb 201 – All Test Method Results

Principle

HemoCue Hemoglobin 201 Microcuvettes HMQ111716 | 200/ea 20.1.44.17.76 85018QW $2.37

Hb 201+ Analyzer

121721

Hb 201 Microcuvettes (200/box)

111716

Hb 201 Individually Packaged Microcuvettes (100/box) 111715

Immunoassay

Specialty

Three Simple Steps

ESR

12.4

g/dL

Hb 201+

1

Fill microcuvette.

2

Place microcuvette into analyzer.

3

View results.

HemoCue America | California, USA Phone 800.881.1611 | Fax 800.333.7043 | info@hemocue.com | hemocue.com

HemoCue has been a leader in point-of-care medical diagnostics for over 30 years. We specialize in giving healthcare providers lab-quality accuracy with results comparable to that of a clinical lab.

Blood Gas

Coagulation Cardiac

LIS/Resources Forms

©2013 HemoCue America All rights reserved. LIT 1056 130118


Lab Portfolio

Alere Determine HIV ALR7D2648 25 ea/bx 20.16.96.17.93 86703 $13.71

Lab Lead Form

Alere Determine HIV

Reduced size for collateral use

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Alere Determine HIV-1/2 Ag/Ab Combo ™

Strep

Additional POC

Enables detection of HIV earlier at the point of care. Urinalysis

The first and only FDA approved rapid point-of-care test that simultaneously and separately detects HIV-1/2 antibodies and free HIV-1 p24 antigen on a single test strip.

Breaking the HIV Infection Cycle

The first point-of-care HIV-1/2 Ag/Ab test

Identifying HIV infection early, during the most infectious stage offers significant benefits, particularly in high risk populations such as men who have sex with men and injecting drug users.

Alere Determine™ HIV-1/2 Ag/Ab Combo has the ability to detect HIV earlier than conventional antibody only tests.2 This enables health care providers to diagnose HIV infection earlier allowing individuals to seek medical care sooner.

• Rapid detection also helps to get patients into effective care and treatment earlier.

• CLIA-waived for fingerstick whole blood.

• Individuals who are unaware of their infection are 3.5 times more likely to transmit the virus to someone else.1 • By detecting HIV earlier, further transmission can be prevented during this highly infectious stage.

Hematology Chemistry

Immunoassay

Specialty

ESR

• Minimal training required.

Blood Gas

• Test in three easy steps. • Results in just 20 minutes.

Coagulation

• Test using whole blood, serum, or plasma. • Proven 99.9% overall clinical sensitivity for all sample types.

for Fingerstick Whole Blood

Cardiac

LIS/Resources To learn more contact your local Account Executive 1.877.441.7440 | AlereHIV.com/US

Forms


Lab Portfolio

Alere Determine HIV ALR7D2648 25 ea/bx 20.16.96.17.93 86703 $13.71

Lab Lead Form

Alere Determine HIV

Test in 3 Easy Steps

1

Prepare Test Bend along the perforation, then tear one strip from the right and remove cover.

2

HbA1c and Glucose

3

Add Sample Fingerstick Whole Blood Apply 50 μL of sample by touching the tip of the capillary tube to the Sample Pad, wait 1 minute, then add Chase Buffer.

1 minute CHASE BUFFER

Read Results Read the results — for both the free HIV-1 p24 antigen (Ag) and HIV-1/2 antibodies (Ab)—in just 20 minutes. Line

Reactive

Nonreactive

Invalid

Lipid Profile Medline POC

Control

Influenza A & B / RSV

Ag Ab

Venous Whole Blood Apply 50 μL of sample by touching the tip of the precision pipette to the Sample Pad, wait 1 minute, then add Chase Buffer.

1 minute CHASE BUFFER

Patient Identification Area Lot Number Product Name

bo HIV Combo HIV Combo H

7

Strep

cont r ol cont r ol cont r ol

Additional POC Control Line Area

Ag Ag

Result Key

Antigen (Ag) Results Area Antibody (Ab) Results Area

Ab Ab Ab

Serum or Plasma Apply 50 μL of sample by touching the tip of the precision pipette to the Sample Pad.

Urinalysis

Sample Pad

Hematology Please refer to the package insert for complete instructions.

Chemistry

Product Information

Product Clinical Performance

Information Type

Product Detail

Method

Lateral Flow

Time to results

20 minutes

Storage conditions

2-30°C (36-86°F)

Test shelf life

18 months*

External controls shelf life

24 months*

Information Type

Overall Clinical Sensitivity

Overall Clinical Specificity

Fingerstick Whole Blood

99.9%

99.8%

Venous Whole Blood

99.9%

99.7%

Serum

99.9%

99.6%

Plasma

99.9%

99.7%

1. Marks G, et al. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. AIDS. 2006; 20(10):1447-5. DOI: 10.1097/01. aids.0000233579.79714.8d 2. Masciotra S, et al. Performance of the Alere Determine™ HIV-1/2 Ag/Ab Combo Rapid Test with specimens from HIV-1 seroconverters from the US and HIV-2 infected individuals from Ivory Coast. Journal of Clinical Virology. 2013; 58(suppl 1):e54-e58. DOI: 10.1016/j. jcv.2013.07.002 *From date of manufacture © 2017 Alere. All rights reserved. The Alere Logo, Alere, Determine and Knowing now matters are trademarks of the Alere group of companies. Any photos displayed are for illustrative purposes only. Any person depicted in such photos is a model. 12000916E-06 01/17

Order Information Product

Specialty

ESR Blood Gas

Order Number

Alere Determine HIV-1/2 Ag/Ab Combo (25 Tests)

7D2648

Alere Determine HIV-1/2 Ag/Ab Combo (100 Tests)

7D2649

External Controls

7D2628

Fingerstick Sample Collection Kit

2604US199

100 Lancets, 100 Bandages, 100 Ethanol Swabs, 100 Gauze Pads

1.877.441.7440 | AlereHIV.com/US

Immunoassay

Verification Panel

KZMC030

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio

Magellan LeadCare II M-B706762 | 48 ea/BX 20.8.12.10.80 83655QW $12.11

Placement Agreement

Magellan LeadCare II

Lab Lead Form HbA1c and Glucose ®

Lipid Profile

The easiest way to test for lead

Medline POC Influenza A & B / RSV

Test, educate and take action, all in one visit.

Strep

We switched to LeadCare II and love it! We get results right away and don’t have to contact patients for follow-up.

– Dr. Ben Spitalnick, Pediatrician

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR •

Convenient

CLIA-waived, just two drops of blood.

• Patient satisfaction

Saves time

Eliminates the need for post-visit follow up.

Blood Gas

• Boosts compliance

Parents appreciate a single visit and a simple fingerstick.

Ensures the test gets done.

• Reimbursable

• Immediate action

Results in 3 minutes, while the patient waits.

Coagulation

CPT code 83655

Cardiac

LIS/Resources TO LEARN MORE

800-305-0197

|

LeadCare2.com

|

LeadCare@magellandx.com

Forms


Lab Portfolio

Magellan LeadCare II M-B706762 | 48 ea/BX 20.8.12.10.80 83655QW $12.11

Placement Agreement

Magellan LeadCare II

Lab Lead Form HbA1c and Glucose

What your peers love about ®

Lipid Profile

Ease of Use | Workflow Efficiency | Accuracy TESTING IS AS EASY AS 1, 2, 3 1

3

2

LeadCare

II

lt Record&Resu ely tely sor Immedia Remove Sen

Collect: 50 µL capillary whole blood (tubes included in the test kit).

Prepare: Dispense blood into a treatment reagent tube and mix.

Medline POC Influenza A & B / RSV

Increased screening significantly. Paid for itself in 9 months.

– Laura Rae Morette, CPNP

Test: Place a drop of sample on the sensor; results in 3 minutes.

Hematology

Compares to GFAAS Reference Method*

Chemistry

70 60

LeadCare II (µg/dL)

– Debra Mykkanen, FNP

Additional POC Urinalysis

ACCURATE love the test – “We quick, easy, accurate!

Strep

50

Immunoassay

40 30

y = 1.04x + 0.12 R2 = 0.992

20 10 0

10

20

30

40

50

60

Specialty 70

GFAAS (µg/dL)

ESR

WE MAKE STARTUP SIMPLE • Online video training & certification. • Technical phone support for troubleshooting. • Free patient educational materials. • All you need is an analyzer & a test kit (includes materials & controls for 48 tests).

Blood Gas

set up, easy “ Easy testing & fast results. ”

Coagulation

– Elide S. Silva, RN, BSN

Cardiac

800-305-0197 | LeadCare2.com LeadCare@magellandx.com *LeadCare II Blood Lead Test Kit Package Insert © 2017 Magellan Diagnostics, Inc. LeadCare is a registered trademark of Magellan Diagnostics, Inc.

LIS/Resources A Meridian Bioscience ® Company

M-0105 Rev 01

Forms


Lab Portfolio

Sekisui OSOM BV OSOM183 25 ea/bx 20.8.16.16.77 87905QW $12.22

Lab Lead Form

OSOM BV BLUE

HbA1c and Glucose RA P I D DI A G NOST ICS

www.sekisuidiagnostics.com

Lipid Profile

®

Medline POC Influenza A & B / RSV

BVBLUE® Test

Strep

THE ONLY CLIA-WAIVED RAPID TEST FOR BACTERIAL VAGINOSIS FOR USE WITH VAGINAL SWABS

FEATURES:

Additional POC

✔ ACCURATE; 92.8% sensitive, 98% specific vs. gram strain ✔ FAST; <1 minute hands-on time ✔ OBJECTIVE; Instant color change provides clear, easy-to-read results

Hematology

✔ COMPREHENSIVE; Detects vaginitis caused by Gardnerella, Bacteroides, Prevotella, and Mobiluncus ®

TEST PROCEDURE / RESULTS POSITIVE Insert swab into pre-filled vial and mix.

✔ WORLD-CLASS TECHNICAL SUPPORT; Staffed with certified medical technologists and skilled professionals

NEGATIVE

Let stand for 10 MINUTES at room temperature.

Immunoassay

BVBLUE® (92.8%)

Add 1 drop of Developer Solution to vial and mix.

ESR

Amsel Criteria (37%)

20%

40%

60%

80%

100%

SENSITIVITY

OR DERING INFO RMAT I O N

Chemistry

Specialty

COMPARISON OF BV DETECTION METHODS*

Read results.

Urinalysis

C O N F I G U R ATI O N

CATAL O G N U M B E R

OS OM ® B V BL UE ® T E S T OS OM ® B V BL UE ® CO N T R O L KIT

25 T EST S

183 184

OS OM ® VA GI N I T IS T R A N S P O R T S YS T E M

50 SWAB SET S

185

Blood Gas Coagulation

Cardiac

THE AMERICAS

DIAGNOSTICS

Sekisui Diagnostics, LLC 31 New York Avenue Framingham, MA 01701 Phone: 800 332 1042 Fax: 800 762 6311 Email: osomrapidtests@sekisuidiagnostics.com ISO 13485:2003 Certified ©2012 Sekisui Diagnostics, LLC – All rights reserved.

* Reference: Sha, Beverly E., Chen, Hua Y., Qiong, J. et al., Utility of Amsel Criteria, Nugent Score and Quantitative PCR for Gardnerella vaginalis, Mycoplasma hominis, and Lactobacillus spp. for Diagnosis of Bacterial Vaginosis in Human Immunodeficiency Virus-Infected Women, Journal of Clinical Microbiology, Sept. 2005, p. 4607-12.

LIS/Resources

BVBLUE® is a registered trademark of Gryphus Diagnostics, LLC. OSOM® and the OSOM Training logo are registered U.S. trademarks of Sekisui Diagnostics, LLC.

MADE IN THE USA

1036-9 07/12

Forms


Lab Portfolio

Sekisui OSOM Trich OSOM181 25 ea/bx 20.8.36.20.94 87808QW $15.29

Lab Lead Form

OSOM Trichomonas

HbA1c and Glucose RA P I D DI A G NO ST IC S

www.sekisuidiagnostics.com

Lipid Profile

®

Medline POC Influenza A & B / RSV

Trichomonas Rapid Test THE ONLY CLIA-WAIVED RAPID TEST FOR THE DETECTION OF TRICHOMONAS VAGINALIS FOR USE WITH VAGINAL SWABS

FEATURES:

Strep

Additional POC

✔ ACCURATE; 83% sensitivity vs. culture; 95% agreement with culture and wet mount combined

Urinalysis

✔ FAST; Results in 10 minutes or less ✔ OBJECTIVE; Detects the antigen; removes uncertainty associated with live organism instability ✔ WORLD-CLASS TECHNICAL SUPPORT; Staffed with certified medical technologists and skilled professionals ®

Hematology

Chemistry

Immunoassay

TEST PROCEDURE / RESULTS

Insert test stick into extracted sample.

Add sample buffer to test tube.

Insert swab and mix.

Let stand 1 MINUTE.

Read results at 10 MINUTES. POSITIVE

Remove swab from test tube.

OR DERING INFORMAT IO N

ESR

NEGATIVE

Blood Gas C O N F I G U R ATI O N

CATAL O G N U M B E R

OSOM ® T R I C HO M O N A S R A P ID T E S T TR I C HOM ON A S P O S IT IVE CO N T R O L KIT

25 T EST S

181 OR 181E (C E MARKE D ) 182 (C E MAR K ED)

OSOM ® VA GI NIT IS T R A N S P O R T S YS T E M

50 SWAB SET S

185

DIAGN OSTICS

Specialty

THE AMERICAS

INTERNATIONAL

Sekisui Diagnostics, LLC 31 New York Avenue Framingham, MA 01701 Phone: 800 332 1042 Fax: 800 762 6311 Email: osomrapidtests@sekisuidiagnostics.com ISO 13485:2003 Certified

Sekisui Diagnostics (UK) Limited 50 Gibson Drive Kings Hill, West Malling, Kent, ME19 4AF, UK Phone: +44 (0) 1732 220022 Fax: +44 (0) 1732 220024 Email: info@sekisuidiagnostics.com ISO 9001:2000 Certified, ISO 13485:2003 Certified

OSOM® and the OSOM Training logo are registered U.S. trademarks of Sekisui Diagnostics, LLC. ©2012 Sekisui Diagnostics, LLC – All rights reserved.

Coagulation

Cardiac LIS/Resources MADE IN THE USA

1036-9 07/12

Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

Urinalysis Medline Urinalysis

Lipid Profile

Medline POC

Siemens Clinitek Status

Influenza A & B / RSV

Siemens Clinitek Novus

Strep usa.siemens.com/cliniteknovus

75 Years of Innovation in Urinalysis CLINITEK Novus Automated Urine Chemistry Analyzer

Siemens Healthcare Diagnostics, the leading clinical diagnostics company, is committed to providing clinicians with the vital information they need for the accurate diagnosis, treatment, and monitoring of patients. Our comprehensive portfolio of performance-driven systems, unmatched menu offering and IT solutions, in conjunction with highly responsive service, is designed to streamline workflow, enhance operational efficiency, and support improved patient care.

CLINITEK Status, Multistix, CLINITEK, MULTISTIX PRO, Clinitest, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. All other trademarks and brands are the property of their respective owners.

SPEND MORE QUALITY TIME WITH YOUR PATIENTS. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Siemens Global Headquarters Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany

Global Siemens Healthcare Headquarters

Siemens AG Healthcare Sector Henkestrasse 127 91052 Erlangen Germany Telephone: +49 9131 84 - 0 www.siemens.com/healthcare

Global Division Siemens Healthcare Diagnostics Inc. 1717 Deerfield Road Deerfield, IL 60015-0778 USA www.siemens.com/diagnostics

Simple, point-of-care urinalysis with enhanced clinical information CLINITEK Status® Family of Analyzers

Results at the Point-of-Care

Product overview

The CLINITEK Novus® Automated Urine Chemistry Analyzer is the next evolution in automated urine chemistry, combining proven dry-pad urine chemistry technology with an easy-to-use cassette test format and using digital cameras to help ensure standardized test results and maximum productivity in busy laboratories.

The CLINITEK Novus analyzer streamlines workflow and delivers consistent, high-quality results, even during peak periods. With a digital camera reading strips, the CLINITEK Novus analyzer improves bilirubin sensitivity and can detect intact RBCs. The CLINITEK Novus analyzer provides reliable operation, high throughput, and standardized results across Siemens Healthare Diagnostics urinalysis systems.

Enhanced Reliability

Trusted Results

Enhanced Productivity

• Card handler provides highly reliable transport of test cards for seamless operation.

• The latest in urine chemistry innovation builds on a 75-year legacy in urinalysis testing.

• Analyzer accepts up to 200 tubes in a single load and processes up to 240 samples/hour.

• Onboard digital 2-D bar-code reader reduces potential for errors reading sample IDs.

• Analyzer uses the same dry pad urine chemistry reagents as Multistix® 10 SG reagent strips.

• Automated entry of lot number and expiration via RFID tag saves operator time and reduces potential for errors.

• LED bulbs and digital camera eliminate need for lamp replacement and decrease maintenance time.

• Results proven to be clinically concordant with the CLINITEK Atlas® and CLINITEK Advantus® Urine Chemistry Analyzers.

• Test cassettes eliminate the need to align the test strips. • Cap detector allows system to skip samples with caps, avoiding probe crashes and downtime.

Our solutions help our customers improve the clinical, operational, and financial (COF) outcomes of their urinalysis testing program. See which outcomes are most important to influencers identified below:

Medline 120 Mini Urine Analyzer & Urinalysis Strips Quick, Reliable www.siemens.com/diagnostics

Why the CLINITEK Novus analyzer?

Answers for life.

Order No. A91DX-0701589-GC2-4A00 | Printed in USA | © 2010 Siemens Healthcare Diagnostics Inc.

Influence decision

Where is testing performed?

• Procurement: Financial • Laboratory technologist/technician: Clinical and operational • Pathologist: Clinical and operational • Urologist: Clinical and operational • C-suite: Financial

Primary: Central laboratory, large urology clinic, reference laboratory

Additional POC

Urinalysis Hematology

Siemens Clinitek AUWi Pro

Aution Eleven AE-4022

Aution Max AX-4030

Chemistry

FULLY AUTOMATED URINE ANALYZER

AUTION MAX

AX-4030

Specifications

Proven Reliability

Test Strips • Glucose • Blood • Urobilinogen

Test Strips Test/Bottle Onboard Capacity Onboard Stability Open Bottle Stability Calibration Frequency

• pH

Specific Gravity

SEMI-AUTOMATED URINE ANALYZER •

• Leukocyte

• Protein

• Bilirubin

• Ketones

AUTION ELEVEN • Nitrite

• Color

• Turbidity

Fully Automated Urine Chemistry • Robust

AUTION Sticks 9EB

AE-4022 100 Strips

• Accurate

• Efficient

Maximum 400 Strips

3 days High Productivity, Proven Technology 31 days None required

Immunoassay

The AUTION ELEVEN Method AE-4022 Semi-Automated Urine Chemistry Analyzer is ideal as a standalone analyzer Dual in wavelength reflectance Testfacilities, Strips medium to high volume as well as a back-up Single wavelength reflectance for blood solution for fully automated urine analyzers. S.G. Reflection refractometry ™

• High throughputColor to meet workload demandsLight transmission Turbidity • Compact footprint saves benchtop space

us, re ics Inc. ands

Light scatter

• Standardization throughout the healthcare network System Description with AUTION strip technology Throughput 225 samples/hour

o

Reaction Time

Quality Results

e ine

Streamline your workflow with one-touch, walkaway urinalysis you can rely on.

.

www.usa.siemens.com/diagnostics

diagnostics

Global Division Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591-5005 USA www.siemens.com/diagnostics

60 seconds Maximum 50 samples Easy to Use

Required Sample Volume • Standardized test strip technology across all ARKRAY platforms Display • Standardized reporting—no subjectivity Communication and eliminates tech to tech variability Data Memory • Clinically significant reporting ranges

mL, 40 mm from bottom of tube • 2Continuous placement of strips • Large Autocolor startLCD when strip is placed

• Color tone automatically identified Dimensions • Abnormal color detection notifies user of Weight potential false positive reactions

• Width: Strips21" do Depth: not require calibration 21" Height: 21 "

General

The CLINITEK AUWi PRO Automated Urinalysis System

Global Siemens Healthcare Headquarters Siemens AG, Healthcare Henkestrasse 127 91052 Erlangen Germany Telephone: +49 9131 84-0 www.siemens.com/healthcare

Sample Loading Capacity

Power Supply • Ability to manually enter clarity results

Compact Size

Operating Environment

• Smallest semi-automated footprint on the market

Specialty

(switchable between one-way two-way) • RS-232C Strips can be placed with right and or left hand tests (includes 200 control tests) • 2,700 Analyzer automatically corrects misaligned strips

37 kg (82 lbs) Improved Quality Control AC, 50/60 Hz • 100-240V QC lockout capability ensures compliance 10-30º C • Temperature: Automatically prompts users to perform Relative humidity: 20-80% (non-condensing) QC testing

• Operator ID lockout restricts instrument use

FULLY AUTOMATED URINE ANALYZER

AUTION MAX

• Maximizes laboratory space • Can be easily transported

Answers for life.

AX-4030

Barcode reader is sold separately.

Minneapolis, MN 55439 • 877.538.8872 • corelab@arkrayusa.com • www.arkrayusa.com

AX005-00 Rev 6/16

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Medline Urinalysis

Medline Mini Urine Analyzer Bundle MPHUA120MP | 500ea/bundle 20.0.50.NEG

Medline Urinalysis 10SG Strip MPHUA10SG | 100ea/bottle 20.0.25.42.12 81003QW $2.25

Medline Urinalysis Albumin/Creatinine Strip MPHUAMAC | 25 ea/bottle 20.3.00.23.20 82044QW & 82570QW $11.41

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

SPEND MORE QUALITY TIME WITH YOUR PATIENTS.

ESR Blood Gas Coagulation

Cardiac LIS/Resources

Medline 120 Mini Urine Analyzer & Urinalysis Strips Quick, Reliable Results at the Point-of-Care

Forms


Lab Portfolio

Medline Mini Urine Analyzer Bundle MPHUA120MP | 500ea/bundle 20.0.50.NEG

Medline Urinalysis

Medline Urinalysis 10SG Strip MPHUA10SG | 100ea/bottle 20.0.25.42.12 81003QW $2.25

Medline Urinalysis Albumin/Creatinine Strip MPHUAMAC | 25 ea/bottle 20.3.00.23.20 82044QW & 82570QW $11.41

Lab Lead Form HbA1c and Glucose

CLIA WAIVED

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

MEDLINE 120 MINI URINE ANALYZER

A quick, convenient way to detect multiple analytes at point-of-care. The Medline 120 Mini Urine Analyzer is intended for use with the Medline Urinalysis test strips. It is specifically designed to improve accuracy and efficiency, allowing you to spend less time testing and more time with your patients. If your staff is currently reading urinalysis strips manually, switch to the Medline 120 Mini Urine Analyzer to save time and standardize patient care.

Accurate and Easy to Use

» Automatic calibration for accurate results and easy operation » Reads Medline Urinalysis MAC, 4, 5, 7 and 10 parameter strips » Minimal training required

Hematology

Chemistry

Immunoassay Specialty

ESR

Convenient to Operate

» Processes up to 120 tests/hour in Continuous Test Mode » Saves and recalls the last 2,000 results automatically » Set QC values to obtain Pass/Fail Summary

Easy Data Management

» Includes RS232C and USB ports for easy data transfer* » Manual or optional barcode-enabled patient ID input

Lockout Functions

» Operator lockout for enhanced compliance » QC lockout enhances compliance and standardizes external QC testing *Note: EMR connectivity through middleware is available at an additional cost.

2 MEDLINE

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Medline Mini Urine Analyzer Bundle MPHUA120MP | 500ea/bundle 20.0.50.NEG

Medline Urinalysis 10SG Strip MPHUA10SG | 100ea/bottle 20.0.25.42.12 81003QW $2.25

Medline Urinalysis Albumin/Creatinine Strip MPHUAMAC | 25 ea/bottle 20.3.00.23.20 82044QW & 82570QW $11.41

Lab Lead Form

Medline Urinalysis

HbA1c and Glucose Medline 120 Mini Urine Analyzer Specifications Feature Analyzer Type Methodology Detection Throughput Test Modes Lockout Functions Memory Strip Incubation Time Wavelength of Monochromatic LED Strips Available Analyzer Ports Capabilities Major Readable Barcodes Calibration Available Languages on the Screen Operating Conditions Storage Conditions Power Source Dimensions (L x W x H) Display Dimensions (L x W) Weight

Specification Semi-automatic Reflectance Photometry Photosensitive Diode Single Test Option: 60 tests/hour, Continuous Test Option: 120 tests/hour Routine, STAT, and QC User/QC Lockout Last 2,000 results 1 Minute 525 nm and 635 nm MAC, 4, 5, 7, 10 Parameters Standard RS232C Port for Barcode Reader or Data Transfer, USB Port for Data Transfer, 25 Pin Parallel Port for External Printer Internal Thermal Printer (Included), RS232C Barcode Reader (optional), Optional External Printer (not included), USB or RS232C Data Transfer Cable (optional) Code 128, Code 39, Codeabar (NW-7), Interleaved 25, UPC-A, UPC-E, EAN 8, EAN 13 Automatic English, Spanish, French, Italian, Portuguese 32 - 104˚F (0 - 40˚C); ≤ 85% RH 23-122˚F (-5-50˚C); ≤90% RH 100-240 VAC, 50-60 Hz 27.2 cm x 18 cm x 10.5 cm (10.7" x 7" x 4.1") 11 cm x 6.5 cm (4.3" x 2.6") 4.2 lbs. (1.9 kg)

MEDLINE URINALYSIS REAGENT STRIPS

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay Specialty

ESR

Get fast, accurate results.

Provide patients with immediate results and assist diagnosis by completing the test in office.

Blood Gas

Accurate

» High quality color chart ensures accurate visual reading » CLIA Waived

Coagulation

Flexible

» Multiple strip configurations to fit your testing needs » Compatible for visual and analyzer reading

Cardiac

Simple

» Analytes appear in the same order as leading brands

LIS/Resources

1-800-MEDLINE (633-5463) | medline.com 3

Forms


Lab Portfolio

Medline Mini Urine Analyzer Bundle MPHUA120MP | 500ea/bundle 20.0.50.NEG

Medline Urinalysis 10SG Strip MPHUA10SG | 100ea/bottle 20.0.25.42.12 81003QW $2.25

Medline Urinalysis Albumin/Creatinine Strip MPHUAMAC | 25 ea/bottle 20.3.00.23.20 82044QW & 82570QW $11.41

Lab Lead Form

Medline Urinalysis

HbA1c and Glucose

Ordering Information

Lipid Profile

Medline 120 Mini Urine Analyzer Item No. MPHUA120MP

Description Medline 120 Mini Urine Analyzer Promo (Includes analyzer and 5 boxes of Medline 10SG urine strips)

Medline POC

Urinalysis Strips

Medline Urinalysis Strips can be read both visually and on the Medline 120 Mini Urine Analyzer (except where noted otherwise). Item No. MPHUA10SG MPHUAURO7 MPHUA5OB MPHUA4OB MPHUA2GP* MPHUAMAC**

Description Medline 10SG Urinalysis Strip Medline URO7 Urinalysis Strip Medline 5OB Urinalysis Strip Medline 4OB Urinalysis Strip Medline 2GP Urinalysis Strip Medline ALB/CRE Urinalysis Strip

Number of Parameters 10 7 5 4 2 2

Influenza A & B / RSV Type of Strip 10SG URO7 5OB 4OB 2GP MAC

Pkg. 100 ea/bt 100 ea/bt 100 ea/bt 100 ea/bt 100 ea/bt 100 ea/bt

Strep

Additional POC

Analytes Item No.

Leukocytes

Nitrite

• • • •

• • • •

MPHUA10SG MPHUAURO7 MPHUA5OB MPHUA4OB MPHUA2GP

Urobilinogen Protein •

• • • • •

pH

Blood

• •

• • •

Specific Gravity •

Ketone

Bilirubin

• •

Glucose Albumin Creatinine • • • • •

Hematology

MPHUAMAC**

Accessories Item No. MPHUABCR MPHUAP87 † ACNUA102 ACNUC011 ACNUC071

Description Medline Barcode Reader Medline Thermal Printer Paper Sticky Printer Paper Liquid Urine Controls, Dropper, 2 x 5mL Liquid Urine Control, Diptube, 2 x 12mL

Pkg. 1 ea 4 ea/pk 4 ea/pk 1 kt 1 kt

*Can only be read visually.

Urinalysis

Chemistry

How to use test strips ‡ Step 1: Immerse strip into urine.

Immunoassay

Step 2: Remove excess urine.

Specialty

** Only for use on Medline 120 Mini Urine analyzer. Can not be visually read. † For use on Medline 120 Mini Urine analyzers and other similar analyzers.

Step 3: Obtain results by analyzer or visual reading.

Contact your Medline Representative or call 1-800-MEDLINE to order yours today.

ESR

OR

Blood Gas

‡ Refer to Product Insert or User’s Manual for complete instructions.

Coagulation Medline Industries, Inc. Three Lakes Drive, Northfield, IL 60093 Medline United States 1-800-MEDLINE (633-5463)

medline.com | info@medline.com

Medline Canada 1-800-396-6996

medline.ca | canada@medline.com

FOLLOW US

Medline México 01-800-831-0898

BLOG

Cardiac

medlinemexico.com | mexico@medline.com

LIS/Resources Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this brochure. ©2017 Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc. MKT1791694 / LIT743R / 2.5M / SG / 10, 3

Forms


Lab Portfolio

Siemens Clinitek Status Urine Analyzer BAHSTARTUA | 1,025/bundle 20.BUNDLE.16.41

Siemens Clinitek Status

Siemens Clinitek Status 10SG Strip BAH2161Z| 100 ea/bottle G20.0.45.0.70 81003QW $2.25

Siemens Clinitek Status Albumin/Creatinine Strip BAH2083Z | 25 ea/bottle G20.4.19.8.79 82044QW & 82570QW $11.41

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas

Simple, point-of-care urinalysis with enhanced clinical information CLINITEK Status® Family of Analyzers

Coagulation

Cardiac LIS/Resources

Answers for life. Forms


Lab Portfolio

Siemens Clinitek Status Urine Analyzer BAHSTARTUA | 1,025/bundle 20.BUNDLE.16.41

Siemens Clinitek Status 10SG Strip BAH2161Z| 100 ea/bottle G20.0.45.0.70 81003QW $2.25

Siemens Clinitek Status Albumin/Creatinine Strip BAH2083Z | 25 ea/bottle G20.4.19.8.79 82044QW & 82570QW $11.41

Lab Lead Form

Siemens Clinitek Status

HbA1c and Glucose

Introducing the

next generation of CLINITEK Status® analyzers designed to improve in-office urine testing

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

CLINITEK Status+ Analyzer – an easy-to-use, automated analyzer designed to deliver quick, accurate, reliable results

NEW

Ensures consistent interpretation of results by removing the subjectivity of visual reading – automatically times and reads every specimen Printed record to help avoid transcription errors

Hematology

Chemistry

Immunoassay

Specialty Ready for connectivity when you are – via simple upgrade kit

Comprehensive urine test menu – including hCG pregnancy testing

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Siemens Clinitek Status Urine Analyzer BAHSTARTUA | 1,025/bundle 20.BUNDLE.16.41

Siemens Clinitek Status 10SG Strip BAH2161Z| 100 ea/bottle G20.0.45.0.70 81003QW $2.25

Siemens Clinitek Status Albumin/Creatinine Strip BAH2083Z | 25 ea/bottle G20.4.19.8.79 82044QW & 82570QW $11.41

Lab Lead Form

Siemens Clinitek Status

HbA1c and Glucose The broadest menu for point-of-care urinalysis testing on one analyzer Product

Tests

Clinical Utility

Multistix® 10 SG and family of test strips

Most widely used urinalysis test strips

Routine testing

CLINITEK® Microalbumin family

Albumin-to-Creatinine ratio test

Detection of early kidney disease for patients with confirmed diabetes

MULTISTIX PRO® family 1

Protein-to-Creatinine ratio test

Detection of early kidney disease for high-risk patients

CLINITEST® hCG

Qualitative hCG test

Pregnancy testing

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

New advanced technology inside the CLINITEK Status+ Analyzer performs automated quality checks on every test

Hematology

Chemistry

Enhanced clinical information for more precise decision making Detects common sample interferences2 and provides a printed comment if it detects certain interferences that could compromise the result (availability dependent on strip type) Checks integrity of each test strip for exposure to humidity and prevents reporting if exposure is detected (available on strips with leukocyte pad) Identifies type of strip automatically, eliminating need for the operator to key in the strip configuration

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources 1. Available for sale in the U.S. and Japan only. 2. Feature not available in the U.S.

Forms


Lab Portfolio

Siemens Clinitek Status Urine Analyzer BAHSTARTUA | 1,025/bundle 20.BUNDLE.16.41

Siemens Clinitek Status 10SG Strip BAH2161Z| 100 ea/bottle G20.0.45.0.70 81003QW $2.25

Siemens Clinitek Status Albumin/Creatinine Strip BAH2083Z | 25 ea/bottle G20.4.19.8.79 82044QW & 82570QW $11.41

Lab Lead Form

Siemens Clinitek Status

HbA1c and Glucose

Lipid Profile

The CLINITEK Status Connect System,

ready to help yo Medline POC

step into the futu Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Operator lockout and access control

Hematology

QC testing and lockout

Chemistry

Immunoassay

CLINITEK Status+ Analyzer

Specialty

ESR Blood Gas Optional barcode data entry

Connector platform for results transmission

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Siemens Clinitek Status Urine Analyzer BAHSTARTUA | 1,025/bundle 20.BUNDLE.16.41

HbA1c and Glucose

Lipid Profile

ready to help you

nto the future

testing and lockout

ptional barcode data entry

Siemens Clinitek Status Albumin/Creatinine Strip BAH2083Z | 25 ea/bottle G20.4.19.8.79 82044QW & 82570QW $11.41

Lab Lead Form

Siemens Clinitek Status

ystem,

Siemens Clinitek Status 10SG Strip BAH2161Z| 100 ea/bottle G20.0.45.0.70 81003QW $2.25

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Operator lockout and access control

The CLINITEK Status Connect System – combines the new CLINITEK Status+ Analyzer and our advanced connector platform Simplifies data entry and integrates with practice management software • Transmits results automatically via middleware for integration into a central database or electronic medical records • Flexible connectivity options – serial, Ethernet or wireless connections – supports HL7 and POCT1-A2 protocols • Supports quality control testing and allows customization of quality control regimen • Optional barcode reader available for accurate patient and operator ID entry • Prevents unauthorized use through programmable operator authorization

Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Siemens Clinitek Status Urine Analyzer BAHSTARTUA | 1,025/bundle 20.BUNDLE.16.41

Siemens Clinitek Status 10SG Strip BAH2161Z| 100 ea/bottle G20.0.45.0.70 81003QW $2.25

Siemens Clinitek Status Albumin/Creatinine Strip BAH2083Z | 25 ea/bottle G20.4.19.8.79 82044QW & 82570QW $11.41

Lab Lead Form

Siemens Clinitek Status

Choose the CLINITEK Status urinalysis analyzer that

meets your needs

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Connectivity pr

Urinalysis CLINITEK Status Family of Analyzers – the next generation of urinalysis analyzers developed with the help of continuous customer input

CLINITEK – Hematology testing from

Trust and conf reliable soluti

Chemistry Do you need... • Printed records • Automatic checks – Automatic humidity exposure check

CLINITEK Status+ Analyzer

CLINITEK Status Connect System

• Most widely analyzers shi

Immunoassay

• CLINITEK and • CLIA-waived

Specialty

– Sample interference notes1 – Automatic identification of strip type

ESR

• Lot and expiration entry with each test • Test results storage (up to 950 patient tests) • Operator ID Storage (up to 700 operators) • QC testing (up to 200 results) • QC test reminders or mandatory testing • Optional barcode scanning (patient/operator/lot/exp) • Optional wireless connectivity • Connectivity to data management software or LIS/HIS

Blood Gas

Coagulation Siemens lea with worldCardiac To learn more

local Siemens H www.siemens.c

LIS/Resources

• HL7 and POCT1-A2 protocols 1. Feature not available in the U.S.

Forms


Lab Portfolio

Siemens Clinitek Status Urine Analyzer BAHSTARTUA | 1,025/bundle 20.BUNDLE.16.41

Siemens Clinitek Status

Siemens Clinitek Status 10SG Strip BAH2161Z| 100 ea/bottle G20.0.45.0.70 81003QW $2.25

Siemens Clinitek Status Albumin/Creatinine Strip BAH2083Z | 25 ea/bottle G20.4.19.8.79 82044QW & 82570QW $11.41

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC The next generation of urinalysis analyzers

Influenza A & B / RSV

Strep

Additional POC Connectivity provides easy access to patient results

Urinalysis Hematology

CLINITEK – a legacy of innovation in urinalysis testing from Siemens Healthcare Diagnostics Trust and confidence based on a heritage of delivering reliable solutions

Chemistry

• Most widely used system worldwide; over 60,000 CLINITEK analyzers shipped • CLINITEK and Multistix – the brands clinicians know and trust • CLIA-waived and CE-marked

Immunoassay Automated hCG pregnancy testing

Specialty

ESR Blood Gas

Siemens leads the way in urinalysis testing with world-class service To learn more about this exciting new offering, contact your local Siemens Healthcare Representative or visit our web site at www.siemens.com/urinalysis or www.usa.siemens.com/urinalysis.

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio

Siemens Clinitek Status Urine Analyzer BAHSTARTUA | 1,025/bundle 20.BUNDLE.16.41

Siemens Clinitek Status 10SG Strip BAH2161Z| 100 ea/bottle G20.0.45.0.70 81003QW $2.25

Siemens Clinitek Status Albumin/Creatinine Strip BAH2083Z | 25 ea/bottle G20.4.19.8.79 82044QW & 82570QW $11.41

Lab Lead Form

Siemens Clinitek Status

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Siemens Healthcare Diagnostics, the leading clinical diagnostics company, is committed to providing clinicians with the vital information they need for the accurate diagnosis, treatment, and monitoring of patients. Our comprehensive portfolio of performance-driven systems, unmatched menu offering and IT solutions, in conjunction with highly responsive service, is designed to streamline workflow, enhance operational efficiency, and support improved patient care.

Chemistry

Immunoassay

CLINITEK Status, Multistix, CLINITEK, MULTISTIX PRO, Clinitest, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. All other trademarks and brands are the property of their respective owners.

Specialty

ESR

Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Blood Gas Siemens Global Headquarters Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany

Global Siemens Healthcare Headquarters Siemens AG Healthcare Sector Henkestrasse 127 91052 Erlangen Germany Telephone: +49 9131 84 - 0 www.siemens.com/healthcare

Global Division Siemens Healthcare Diagnostics Inc. 1717 Deerfield Road Deerfield, IL 60015-0778 USA www.siemens.com/diagnostics

Simple, enhance

Coagulation

Cardiac CLINITEK Stat LIS/Resources

www.siemens.com/diagnostics Order No. A91DX-0701589-GC2-4A00 | Printed in USA | © 2010 Siemens Healthcare Diagnostics Inc.

Answers fo Forms


Lab Portfolio Lab Lead Form

Siemens Clinitek Novus

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV usa.siemens.com/cliniteknovus

75 Years of Innovation in Urinalysis CLINITEK Novus Automated Urine Chemistry Analyzer

Strep

Additional POC

Why the CLINITEK Novus analyzer?

Product overview

The CLINITEK Novus® Automated Urine Chemistry Analyzer is the next evolution in automated urine chemistry, combining proven dry-pad urine chemistry technology with an easy-to-use cassette test format and using digital cameras to help ensure standardized test results and maximum productivity in busy laboratories.

The CLINITEK Novus analyzer streamlines workflow and delivers consistent, high-quality results, even during peak periods. With a digital camera reading strips, the CLINITEK Novus analyzer improves bilirubin sensitivity and can detect intact RBCs. The CLINITEK Novus analyzer provides reliable operation, high throughput, and standardized results across Siemens Healthare Diagnostics urinalysis systems.

Urinalysis Hematology

Chemistry

Immunoassay

Specialty Enhanced Reliability

Trusted Results

Enhanced Productivity

• Card handler provides highly reliable transport of test cards for seamless operation.

• The latest in urine chemistry innovation builds on a 75-year legacy in urinalysis testing.

• Analyzer accepts up to 200 tubes in a single load and processes up to 240 samples/hour.

• Onboard digital 2-D bar-code reader reduces potential for errors reading sample IDs.

• Analyzer uses the same dry pad urine chemistry reagents as Multistix® 10 SG reagent strips.

• Automated entry of lot number and expiration via RFID tag saves operator time and reduces potential for errors.

• LED bulbs and digital camera eliminate need for lamp replacement and decrease maintenance time.

• Results proven to be clinically concordant with the CLINITEK Atlas® and CLINITEK Advantus® Urine Chemistry Analyzers.

• Test cassettes eliminate the need to align the test strips. • Cap detector allows system to skip samples with caps, avoiding probe crashes and downtime.

Our solutions help our customers improve the clinical, operational, and financial (COF) outcomes of their urinalysis testing program. See which outcomes are most important to influencers identified below: Influence decision

Where is testing performed?

• Procurement: Financial • Laboratory technologist/technician: Clinical and operational • Pathologist: Clinical and operational • Urologist: Clinical and operational • C-suite: Financial

Primary: Central laboratory, large urology clinic, reference laboratory

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Siemens Clinitek Novus

How we win against the competition CLINITEK Novus Analyzer

iCHEM VELOCITY (Iris)

AUTION 4030 (Arkray)

200

60

100

Loading Capacity Speed

240/hour

Chemistry Reagent

CLINITEK Novus 10 Reagent Cassette

iCHEM URINE CHEMSTRIP vial

9HA urine strips

14 days

5 days

1 day

CLINITEK Advantus Analyzer CLINITEK Status® Connect System

N/A iCHEM 100 EOS

N/A

Onboard Stability Backup Instrument

200/hour

FAQs

• Iris iCHEM VELOCITY customers who are dissatisfied

What are the key differences between the CLINITEK Novus and CLINITEK Atlas analyzers? The CLINITEK Novus analyzer represents the next generation in automated UA, incorporating a number of unique technologies:

• Arkray chemistry analyzers

Urinalysis customers to target • Customers doing at least 50 urines per day and seeking automation • Large urology group practices with moderately complex licenses • Sites looking to automate their urinalysis workflow • Existing CLINITEK Status Connect and CLINITEK Advantus customers who are using non-Siemens Healthcare Diagnostics instruments in their central laboratory

How to prospect (probing questions to ask) 1. What are the customer’s goals for UA in their facility? 2. What are the key drivers (immediate lab-quality results, cost reduction, standardization, false-positive/falsenegative reduction, improved workflow, improved productivity, time savings, regulatory compliance, favorable reimbursement)? 3. How important are improved workflow, validated patient results, connectivity to EMR/LIS, flexibility, and the ability to upgrade to an automated system that employs the same urine chemistry methodology?

Lipid Profile

Medline POC Influenza A & B / RSV

Competitive customers to target • Roche COBAS U 411/legacy UA instruments

HbA1c and Glucose

• Reagent cassette with cards and RFID chip • Digital camera that takes seven images using the full light spectrum • 2-D bar-code reader and cap detector What makes our end-to-end solution unique? Siemens Healthcare Diagnostics is the only vendor that uses the same dry pad chemistry reagents across the product portfolio, maximizing concordance of results.

Strep

Additional POC

Urinalysis Hematology

How long are cassettes stable onboard? Cassettes are stable onboard for 14 days. During this time, they can be moved between instruments.

Chemistry

What should I quote my customer as a backup instrument? You can propose a CLINITEK Status Connect System for sites that want hCG in the lab and are running lower volumes (~50–75 urines/day). The CLINITEK Advantus analyzer is the backup for high-volume sites (>100 urines/day).

Immunoassay

Specialty

Additional support materials: Siemens Healthcare Diagnostics UA Family brochure, CLINITEK Atlas to CLINITEK Novus analyzer, CLINITEK Novus sell sheet and brochure, POC Portfolio brochure, CUA Right Fit Strategy brochure (customer-facing).

ESR Blood Gas Coagulation

CLINITEK Advantus, CLINITEK Atlas, CLINITEK Novus, CLINITEK Status, Multistix, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Legal Manufacturer Siemens Healthcare Diagnostics Inc. Point of Care Diagnostics 2 Edgewater Drive Norwood, MA 02062-4637 USA Phone: +1 781-269-3000

Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84-0 siemens.com/healthineers

Cardiac LIS/Resources Forms

Order No. 40-17-10228-01-76 | 09-2017 | © Siemens Healthcare Diagnostics Inc., 2017


Lab Portfolio Siemens Clinitek AUWi Pro

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

Streamline your workflow with one-touch, walkaway urinalysis you can rely on. The CLINITEK AUWi PRO Automated Urinalysis System

ESR Blood Gas

www.usa.siemens.com/diagnostics

Coagulation

Cardiac LIS/Resources

Answers for life.

Forms


Lab Portfolio Lab Lead Form

Siemens Clinitek AUWi Pro

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Auto with

Hematology

Chemistry Walkaw The CLINITEK AUWi PRO System unites urine chemistry and sediment testing on a smallfootprint platform that maximizes your throughput and productivity.

Reliable urinalysis testing, from start to finish. The CLINITEK AUWi PRO Automated Urinalysis System combines two trusted technologies on a single platform to provide true walkaway urine chemistry testing and sediment analysis. Seamless integration of the CLINITEK Novus™ Urine Chemistry Analyzer and the Sysmex UF-1000i ™ Urine Particle Analyzer* delivers load-and-go productivity for automated urinalysis without compromise.

Harnessing the Power of Two Exceptional Analyzers

*Product is available for sale in U.S. and Canada only.

• Workstations are linked by a common sample track and integrated with powerful workflow management software for unattended operation with complete confidence

®

2

• CLINITEK Novus analyzer combines proven dry-pad urine chemistry technology with an easy-to-use cassette test format to ensure standardized test results • Sysmex UF-1000i analyzer standardizes and provides fully quantitative urine sediment results using high-sensitivity fluorescent flow cytometry

• Automat to anoth Immunoassay on other

• Automat analysis Specialty and labo

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Forms


Lab Portfolio Lab Lead Form

Siemens Clinitek AUWi Pro

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC Tiltable color touch screen with intuitive navigation and flexible menu options.

Automated urinalysis without compromise.

Dependable clinical results.

Walkaway Capability

CLINITEK Novus Analyzer

• Automatically transports samples from one analyzer to another, allowing you to walk away and focus on other tasks

• Advanced color correction improves test accuracy

• Automatically reflexes samples requiring sediment analysis using customer-defined rules, reducing the time and labor associated with manual microscopic analysis • Autoverification of results to be reported to the LIS is based on tailored rules • Integrates urine chemistry and sediment results into a user-defined, consolidated patient report • Software automatically flags abnormal results requiring later review

Increased Productivity

Urinalysis Hematology

Chemistry

Immunoassay

• Clinically appropriate detection level of blood improves disease detection • Excellent correlation of urine chemistry results with those obtained on a reference system⁑

Specialty

Sysmex UF-1000i Analyzer • Sediment classification is accurate and consistent

ESR

• Separate measurement channel enhances bacteria detection

Blood Gas

• 99% negative predictive value for screening of Urinary Tract Infection§ • Anti-carryover function ensures integrity of results

Coagulation

• Continuous load-and-go processing with no centrifugation, reduced off-line dilutions, and fewer manual steps

Cardiac

• Minimized sample handling from pre- to post-analysis • You can load up to 200 sample tubes simultaneously, and complete up to 80 tests per hour while performing other duties

LIS/Resources

⁑ Zercher AE, Schulman LS, Zimmerle CT; Clinical Performance of the New CLINITEK Novus Urine Chemistry Analyzer. Elkhart (IN): Siemens; 2012. §

Citation: Wang, et al. Am J Clin Pathol 2010; 133:577-582

3

Forms


Lab Portfolio Siemens Clinitek AUWi Pro

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

The CLINITEK Novus analyzer automates urine chemistry workflow and standardizes testing. Improve Reliability and Throughput with Technology You Can Trust High-throughput testing on the CLINITEK Novus analyzer enhances workflow, simplifies analysis, and maximizes your laboratory productivity. Dependable dry-pad urine chemistry technology provides actionable results for a broad range of markers.

• Live calibration of all analytes provides confidence in results • Ready-to-use liquid calibration material enhances accuracy • CLINITEK Novus 10 cassettes meet routine urinalysis requirements for important markers

Hematology

Chemistry

• Liquid-level sensing speeds and simplifies sample preparation

Remo from U

Immunoassay Fluores

Specialty

• Proven test pads ensure quality results with excellent sensitivity and specificity • Easy-to-use cassettes simplify analyzer operation, maintenance, and cleaning

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and ma automa flow cy

• Autom flagge

ESR

• Reliab of nor manu

Blood Gas

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Coagulation

Cardiac LIS/Resources

4

Forms

Im


Lab Portfolio Lab Lead Form

Siemens Clinitek AUWi Pro

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

The Sysmex UF-1000i analyzer standardizes and provides fully quantitative urine sediment results. Remove Operator-to-Operator Variability from Urine Particle Analysis Fluorescent flow cytometry is less subjective than imaging and manual microscopy. The Sysmex UF-1000i analyzer automates sample handling and analysis with fluorescent flow cytometry that delivers outstanding precision. • Automatically classifies 11 formed elements/ flagged parameters

Chemistry

• Reduced review rate—“no image review” technology helps deliver the walkaway performance required by busy labs

Immunoassay

• Cell counting capability of up to 80,000 particles reduces manual review rate • Eliminates amorphous crystal formation to ensure accurate results

Specialty

• Reliable identification analysis and auto-identification of normal samples eliminates the need for further manual steps

ESR Blood Gas

See a Clearer Picture Accuracy is a function of sample size. The Sysmex UF-1000i workstation sees the whole picture by analyzing more of the sample and providing fully quantitative results without subjective interpretation.

Imaging analyses < 1 uL 1 HPF

Hematology

Manual 2.5 µL 10 HPF

Coagulation

Cardiac LIS/Resources

UF-1000i 9.0 µL 36 HPF

5

Forms


Lab Portfolio Lab Lead Form

Siemens Clinitek AUWi Pro

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep With the Urinalysis WAM software, you are in control of the entire testing process. Scattergrams and histograms are graphically displayed.

Take control of the entire testing process.

Additional POC

Urinalysis

An intuitive, easy-to-use interface guides every aspect of your urinalysis testing.

• Scattergrams and histograms, Levey-Jennings, and radar charts are graphically displayed

Hematology

• Urine chemistry and sediment results are combined in a consolidated patient report

• Sophisticated data management capabilities include rules-based real-time data checking, delta checking, patient record tracking, and customized results reporting

Chemistry

• Urinalysis WAM software offers step-by-step tutorials

Immunoassay

Specialty

ESR

CLINITEK Status® Analyzer

CLINITEK Advantus® Analyzer

CLINITEK Novus Analyzer

CLINITEK AUWi PRO System

Proven performance in urinalysis—from the central laboratory to the point of care. CLINITEK urine chemistry systems from Siemens Healthcare Diagnostics employ the same proven testing technology regardless of the test format. You can be sure of standardized test results in every setting, from the highvolume automated laboratory to point-of-care locations. Superior customer service coupled with the support you need to address your urine chemistry challenges completes our CLINITEK offering. We work closely with every customer to implement rules to fit individual 6

workflow needs. We also provide on-site user training, comprehensive online educational materials, and 24/7 technical support. The CLINITEK brand remains recognized the world over as the leader in reliable urinalysis testing—meeting the needs of different patient populations, enhancing productivity, and providing broad clinical insights into patient health. You can rely on Siemens to support you with performancedriven urinalysis solutions you can trust.

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Siemens Clinitek AUWi Pro

HbA1c and Glucose

CLINITEK AUWi PRO Automated Urinalysis System CLINITEK Novus Analyzer with CLINITEK Novus Cassettes

Sysmex UF-1000i Analyzer

Lipid Profile

CLINITEK Novus 10 Cassette Bilirubin Occult Blood Clarity Glucose Protein Color Ketone Urobilinogen pH Leukocyte Specific Gravity Nitrite

Menu

• Dry-pad urine chemistry • Color change measured by reflectance photometry Measurement Technology

• Dual readings at reactive and reference wavelengths • Specific gravity measured by refractive index method

Formed Elements Bacteria White Blood Cells Epithelial Cells Hyaline Casts Red Blood Cells

Medline POC Influenza A & B / RSV

Flagged Parameters Crystals Sperm Yeast like cell Pathological Casts Small Round Cells Mucus

Strep

Additional POC

• Urine fluorescent flow cytometry • Two stains with fluorescent dye

Urinalysis

• Separate bacteria channel for improved discrimination

Hematology

• Clarity measured by transmitted and scattered light

Chemistry

Immunoassay

General Specifications Maintenance

10 minutes daily, 10 minutes monthly

Dimensions

Depth: 35” (88 cm) Width:‡ 63” (160 cm) Height: 27” (68 cm)

Weight

382 lb (173 kg)

Power

120 V, 50/60 Hz

Specialty

ESR

Product safety – CLINITEK Novus Analyzer – Sysmex UF-1000i Analyzer

Blood Gas

TUV, CE, EMC, IEC 61326 UL, CSA, CE, EMC, IEC (EN), EME, EMS

Sample volume

5 mL in automated mode, 2 mL in manual mode

Sample capacity

10-position sample racks, up to 10 racks (100 samples)

Sample tubes

15–16 mm outer diameter, 100–104 mm length

Bar codes

Interleaved 2 of 5, Codabar (NW-7), Code 39, Code 128

Throughput

Up to 80 tests per hour

Communication

Single, bidirectional interface (Serial/TCP/IP), connecting data manager to LIS (ASTM/HL7)

Coagulation

Cardiac LIS/Resources

‡Not including computer monitor.

Forms 7


Lab Portfolio Lab Lead Form

Siemens Clinitek AUWi Pro

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

.

Chemistry

CLINITEK, CLINITEK Advantus, CLINITEK Novus, CLINITEK Status, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Immunoassay

Specialty

Sysmex is a trademark of the Sysmex Corporation. The official product name of the Sysmex UF-1000i is the Sysmex UF-1000i Urine Particle Analyzer.

Stream walka Blood Gas ESR

Order No. A91DX-POC-141602-UC1-4A00 3-2015 | All rights reserved © 2015 Siemens Healthcare Diagnostics Inc.

The CLINIT

Coagulation www.usa. Global Siemens Headquarters Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany

Global Siemens Healthcare Headquarters Siemens AG, Healthcare Henkestrasse 127 91052 Erlangen Germany Telephone: +49 9131 84-0 www.siemens.com/healthcare

Global Division Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591-5005 USA www.siemens.com/diagnostics

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Aution Eleven AE-4022

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV SEMI-AUTOMATED URINE ANALYZER

AUTION ELEVEN

AE-4022

High Productivity, Proven Technology

Strep

Additional POC

Urinalysis

The AUTION ELEVEN™ AE-4022 Semi-Automated Urine Chemistry Analyzer is ideal as a standalone analyzer in medium to high volume facilities, as well as a back-up solution for fully automated urine analyzers.

Hematology

• High throughput to meet workload demands • Compact footprint saves benchtop space

Chemistry

• Standardization throughout the healthcare network with AUTION strip technology

Immunoassay Quality Results

Easy to Use

• Standardized test strip technology across all ARKRAY platforms

• Continuous placement of strips

• Standardized reporting—no subjectivity and eliminates tech to tech variability

• Strips can be placed with right or left hand

• Auto start when strip is placed

• Clinically significant reporting ranges

• Analyzer automatically corrects misaligned strips

• Color tone automatically identified

• Strips do not require calibration

• Abnormal color detection notifies user of potential false positive reactions

Improved Quality Control

• Ability to manually enter clarity results

• QC lockout capability ensures compliance

Compact Size

• Automatically prompts users to perform QC testing

• Smallest semi-automated footprint on the market

• Operator ID lockout restricts instrument use

• Maximizes laboratory space

Specialty

ESR Blood Gas Coagulation

Cardiac

• Can be easily transported

LIS/Resources Barcode reader is sold separately.

Forms


Lab Portfolio Lab Lead Form

Aution Eleven AE-4022

HbA1c and Glucose SEMI-AUTOMATED URINE ANALYZER

AUTION ELEVEN

Lipid Profile

Specifications

Medline POC

AE-4022

Test Strips Measurement Items

• Glucose • Protein • Bilirubin

Test Strips

AUTION Sticks 10EA

Tests/bottle

100 Strips

Open Bottle Stability

31 days

Calibration Frequency

None required

• pH • Blood • Urobilinogen

• Ketone • Nitrite • Leukocyte

• Specific Gravity • Color tone

Influenza A & B / RSV

Strep

Additional POC

Method Test Strips

Dual wavelength reflection photometric method Single wavelength reflectance for blood

Color

23 categories of color tone calculated using reflectance

Clarity

Manually input the value of urine clarity obtained visually

Urinalysis Hematology

System Description Analyzer Type

Semi-automated urine chemistry analyzer

Throughput

514 samples/hour

Reaction Time

60 seconds

Sample Loading

Every seven seconds

Memory

520 tests

Communication

RS-232C

Chemistry

Immunoassay

Specialty

General Dimensions

8.3” (w) x 12.9” (d) x 6.5” (h)

Weight

7.9 lbs

Power Supply

100–240 V, 50/60 Hz

Measurement Environment

Temperature: 50–86º F, (10–30° C) Relative Humidity: 30–60%

ESR Blood Gas Coagulation

Cardiac LIS/Resources Minneapolis, MN 55439 • 877.538.8872 • corelab@arkrayusa.com • www.arkrayusa.com

6462-00 Rev 11/16

Forms


Lab Portfolio Lab Lead Form

Aution Max AX-4030

HbA1c and Glucose

Lipid Profile

Proven Reliability

Medline POC Influenza A & B / RSV

Fully Automated Urine Chemistry • Robust

• Accurate

• Efficient

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

FULLY AUTOMATED URINE ANALYZER

AUTION MAX AX-4030

Cardiac LIS/Resources Forms


Lab Portfolio Aution Max AX-4030

Lab Lead Form HbA1c and Glucose

Maximize urinalysis workflow efficiency with the AUTION MAX™ AX-4030. The fully automated urine chemistry analyzer features an improved design for highquality reliable results to efficiently meet laboratory workload demands.

Profile The Lipid analyzer is easy to Operators become rap produce urine chemist oneMedline minute.POC • Simple strip loading

• Easy-to-navigate LCD sc

Influenza A & B / RSV

• Built-in thermal printer

• Rapid operator proficien

• Minimal maintenance, 5 Strep and 10 minutes monthly

Additional POC The robust AUTION M without interruption. Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR • Simply load specimens, press start, and walk away • Continuous loading of up to 100 samples • Process up to 225 samples per hour

Blood Gas Standardize urinalysis with the AUTION MAX Coagulation

• Identical test strip techn

• Ideal backup solution to

• Effortless transition from

Cardiac

• STAT interrupt capabilities

LIS/Resources

Reliable urine c Forms


Lab Portfolio Lab Lead Form

Aution Max AX-4030

HbA1c and Glucose

The analyzer is easy to use and maintain. Operators become rapidly proficient and can produce urine chemistry results in approximately one minute.

Lipid Profile

Medline POC

• Simple strip loading • Easy-to-navigate LCD screen

Influenza A & B / RSV

• Built-in thermal printer • Rapid operator proficiency • Minimal maintenance, 5 minutes daily/weekly and 10 minutes monthly

Strep

The robust AUTION MAX™ AX-4030 generates accurate and reliable urine chemistry results without interruption. • Trusted test strips used for decades

Additional POC

Urinalysis

• Second generation analyzer • Fluidics and feeder design enhancements • Minimal downtime

Hematology

• Flexible loading of up to 400 strips

Chemistry

AUTION Sticks 9EB • Easy to load strips that do not require calibration • Excellent sensitivity and specificity

Immunoassay

• Clinically significant reporting ranges • Color compensation pad corrects results for normal urine colors

Specialty

• Abnormal color detection alerts users of potential false positive reactions

ESR Blood Gas Standardize urinalysis results across many laboratories within a healthcare system with the AUTION MAX™ AX-4030. • Identical test strip technology used across entire AUTION product line

Coagulation

• Ideal backup solution to the AUTION HYBRID™ AU-4050 • Effortless transition from the AUTION MAX™ AX-4280

AUTION MAX AX-4030 Reliable urine chemistry to meet laboratory quality and efficiency goals.

Cardiac LIS/Resources

Forms


Lab Portfolio Lab Lead Form

Aution Max AX-4030

HbA1c and Glucose FULLY AUTOMATED URINE ANALYZER

AUTION MAX

Lipid Profile

AX-4030

Specifications

Medline POC

Test Strips • Glucose

• pH

• Leukocyte

• Protein

• Blood

• Specific Gravity

• Bilirubin

• Ketones

• Urobilinogen

• Nitrite

• Color

• Turbidity

Test Strips Test/Bottle Onboard Capacity Onboard Stability Open Bottle Stability Calibration Frequency

AUTION Sticks 9EB 100 Strips Maximum 400 Strips 3 days 31 days None required

Influenza A & B / RSV

Strep

Additional POC

Method

Urinalysis

Test Strips

Dual wavelength reflectance Single wavelength reflectance for blood

S.G.

Reflection refractometry

Color

Light transmission

Turbidity

Light scatter

Hematology

Chemistry

System Description Throughput

225 samples/hour

Reaction Time

60 seconds

Sample Loading Capacity

Maximum 50 samples

Required Sample Volume

2 mL, 40 mm from bottom of tube

Display

Large color LCD

Communication

RS-232C (switchable between one-way and two-way)

Data Memory

2,700 tests (includes 200 control tests)

Immunoassay

Specialty

ESR

General Dimensions

Width: 21" Depth: 21" Height: 21 "

Weight

37 kg (82 lbs)

Power Supply

100-240V AC, 50/60 Hz

Operating Environment

Temperature: 10-30º C Relative humidity: 20-80% (non-condensing)

Blood Gas Coagulation

Cardiac LIS/Resources Minneapolis, MN 55439 • 877.538.8872 • corelab@arkrayusa.com • www.arkrayusa.com

AX005-00 Rev 6/16

Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

Hematology CDS M-Series Hematology Analyzers

Siemens ADVIA 360/560

Diatron Abacus 3CP

Lipid Profile

Medline POC Diatron Abacus 5

The Leading Selling* 3-part diff Hematology Analyzer in the U.S

Strep Abacus 3CP 3-PART WBC DIFFERENTIAL ANALYZER

Multiple Sampling Methods

nds

User-friendly

Global Siemens Healthcare Headquarters Siemens AG, Healthcare Henkestrasse 127 91052 Erlangen Germany Telephone: +49 9131 84-0 www.siemens.com/healthcare

Global Division Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591-5005 USA www.siemens.com/diagnostics

Scalable Hematology Systems: Offering the Right Fit for Every Laboratory ADVIA 360, ADVIA 560, and ADVIA 560 AL Hematology Systems

nostics

Touch screen displays and on board step-by-step instruction makes operation easy and adaptable for different users. Zero Daily / Weekly Maintenance

NOW with enhanced usability features with our latest software update that include:

Engineered to eliminate lengthy cleaning procedures and maximize efficiency. Patented Finger Stick Technology

Abacus 5

5-PART LASER WBC DIFFERENTIAL ANALYZER

Additional POC

Options to best fit your needs with: Closed Tube, Open Vial, or Autoloader. All include MPA (Micro Pipette Adapter).

www.siemens.com/diagnostics

Influenza A & B / RSV

• Easier Guided Calibration Procedure • Secured Access for Authorized Users • Maintenance Notifications

• Operator ID Scanning Capability

One drop of blood is all it takes. With our MPA (micro-pipette adapter), a finger stick sample gives full blood status in less than a minute. Perfect for children and hard to draw patients!

Answers for life.

PN204401A RTBD

Simply take a finger stick sample. Draw blood into the special 20 µl microcapillary tube.

Slide it into the adapter and insert in the analyzer.

Urinalysis

Results will display in approx. one minute. No pre-dilution.

Hematology Horiba Micros 60

Beckman Coulter DxH 520

Beckman Coulter DxH 600/800 DxH 800 and DxH 600 Cellular Analysis Systems

TECHNOLOGY ADVANCEMENTS IN CBC METHODOLOGY

Chemistry

Immunoassay

Introduction Complete blood count (CBC) is a fundamental analytical test that evaluates three main cellular components: white blood cells (WBCs), red blood cells (RBCs) and platelets (PLTs). The DxH 800 and DxH 600 analyzers incorporate innovative electronic and mechanical designs that, in conjunction with advanced algorithms, improve system performance and uptime. These designs and algorithms also work together to enhance the sensitivity and resolution of cell counting at critical decision levels for the analysis of whole blood and body fluids samples, providing the highest quality patient results.

The DxH 800 and DxH 600 CBC Processes The DxH 800 and DxH 600 CBC modules perform both sample preparation and management. WBC, RBC and PLT cellular triple aperture counts and volumes, as well as hemoglobin (HGB) measurement information, are processed and provided in digital format by the advanced DxH 800 and DxH 600 algorithms.

DxH 520 5-part differential closed tube hematology analyzer

The CBC algorithms have four analysis modules, one each for WBCs, RBCs, PLTs and HGB. The WBC, RBC and PLT algorithms utilize digital count and size information to:

› › › ›

Perform coincidence correction

Specialty

Calculate individual aperture and average parameter counts Generate individual and average parameter histograms Perform count and histogram voting

The advanced algorithms then analyze WBC, RBC and PLT histograms for interferences and automatically correct or flag the results. DataFusion, which is a proprietary capability that incorporates hardware technology and advanced software analyses, enhances flagging confidence. It generates cellular information from the CBC, differential, optical NRBC scatter and reticulocyte modules to identify interferences, enhance result confidence and help ensure superior CBC results.

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens ADVIA 360/560

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

www.siemens.com/diagnostics

Scalable Hematology Systems: Offering the Right Fit for Every Laboratory

ESR Blood Gas

ADVIA 360, ADVIA 560, and ADVIA 560 AL Hematology Systems Coagulation

Cardiac LIS/Resources

Answers for life.

Forms


Lab Portfolio Lab Lead Form

Siemens ADVIA 360/560

HbA1c and Glucose

Your Laboratory Requirements

are Evolving

The Siemens Family of Hematology Analyzers: Scalable Solutions that Evolve with Your Needs

Scalable Hematology Testing Options to Meet Your Laboratory’s Unique Challenges

While the driving trend in today’s clinical testing environment is consolidation, not every laboratory is affected by this paradigm shift. With major swings in testing volumes from laboratory to laboratory and network to network, one model does not fit all. Such diversity in laboratory workload builds a demand for diversity in analyzers—and scalable options are paramount.

Siemens now offers feature-rich, lower-capacity hematology testing systems with the flexibility to scale up to meet increases in testing demands. No matter what your capacity requirements, Siemens offers the system to fit your needs. With the ADVIA® 360 System, ADVIA 560 System, and ADVIA 560 AL System, Siemens offers state-of-the-art hematology testing capabilities for small to mid-sized laboratories—or as back-up for systems in your main laboratory.

Lipid Profile

The ADVIA Medline POC 360, and ADVIA 560 A

Three Influenza A & Boption / RSV

needs and bu

The low- and mid-volume Strephematology tes for various optimize and manage wor choice of open- or closedAutomatic anti-clogging a Additional POCto ensure fifteenth sample maintenance, this reduces

Fast, high-quality CB

Urinalysis

Fast, reliable, and flexible, The systems have been en a wealth of user benefits,

Hematology Intuitive hardware featu

• Cap-piercing function for

• Easy-to-operate color tou

Chemistry

• Choice of manual or auto

• Handheld bar-code read control information

Immunoassay • Result printing does not d

Intuitive software featur

Specialtyoperating me • Multilingual

• Bidirectional LIS commun between laboratories and

• Flexible ESRand efficient inte USB and QR codes

• Customizable printing opt

• Built-in diagnostic flaggin Blood Gas abnormal results

Coagulation

Cardiac LIS/Resources

2

Forms


Lab Portfolio Siemens ADVIA 360/560

Lab Lead Form HbA1c and Glucose

Lipid Profile

The ADVIA 360, ADVIA 560, and ADVIA 560 AL Hematology Systems

Medline POC

Three options to fit your workflow needs and budget

Influenza A & B / RSV

The low- and mid-volume family of ADVIA systems offers cost-efficient solutions for various hematology testing volumes and environments. The systems help optimize and manage workflow through convenient features, including the choice of open- or closed-tube sampling, and customizable result printing. Automatic anti-clogging and cleaning procedures are employed after every fifteenth sample to ensure reliability of results. Along with automated maintenance, this reduces manual procedures and biohazard exposure.

Fast, high-quality CBC testing in any laboratory environment

Strep

Additional POC ADVIA 360 Hematology System

Urinalysis

Fast, reliable, and flexible, these systems can run up to 60 samples per hour. The systems have been engineered for safety and ease-of-operation, and deliver a wealth of user benefits, including:

Hematology

Intuitive hardware features for accurate and rapid results • Cap-piercing function for accurate sampling and reduced biohazard risk • Easy-to-operate color touchscreen with intuitive icon-based software

Chemistry

• Choice of manual or automatic calibration procedures • Handheld bar-code reader for easy entry of patient ID and control information

Immunoassay

• Result printing does not delay tests in progress Intuitive software features and customizable options

Specialty

• Multilingual operating menu enables usability among diverse staff • Bidirectional LIS communication facilitates easy patient data transfer between laboratories and minimizes paper-based work lists

ADVIA 560 Hematology System

ESR

• Flexible and efficient interface enables uploading reference data via USB and QR codes • Customizable printing options include tabular reports • Built-in diagnostic flagging system automatically alerts operator of abnormal results

Blood Gas Coagulation

Cardiac ADVIA 560 AL Hematology System

LIS/Resources

3

Forms


Lab Portfolio Lab Lead Form

Siemens ADVIA 360/560

HbA1c and Glucose

Lipid Profile

ADVIA 360 Hematology System

Compact footprint and remarkable accuracy in a cost-efficient system The ADVIA 360 System allows smaller laboratories to efficiently generate reliable and accurate results. With a compact footprint, the ADVIA 360 System conserves precious benchtop space.

• Facilitates efficient manual sampling of both open and closed tubes

• Runs up to 60 samples per hour

• Provides storage capacity of 10,000 results

• Processes aspiration volumes as low as 100 μL

• Streamlines result reporting via an integrated ticket printer

• Measures 22 parameters, including a 3-part white blood cell differential*

*Not all parameters are available in the U.S.

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Hematology

ADVIA 560 and 5

Chemistry Maximum ou

The ADVIA 560 System can hematology analyzer in sm or as a backup for the ADV Immunoassay laboratories. The ADVIA 56 sampling with an optional the system at any time to a

Specialty

Optimal performance an

The ADVIA 560 System off and safety features of the ESRcapabilities: following

Blood Gas

ADVIA 560 AL Sy

ACoagulation true “walk-

For even greater workflow System streamlines automa simply plugs into the side o evenCardiac more convenient feat

• 100 primary sample tube 10 sample tubes each)

• Ability to accept a variety LIS/Resources

4

Forms


Lab Portfolio Lab Lead Form

Siemens ADVIA 360/560

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Hematology

ADVIA 560 and 560 AL Hematology Systems

Maximum output with minimal user intervention The ADVIA 560 System can serve as the primary hematology analyzer in small to mid-sized laboratories, or as a backup for the ADVIA 2120i System in larger laboratories. The ADVIA 560 AL System offers automatic sampling with an optional autoloader that can be added to the system at any time to adapt to your ever-evolving needs. Optimal performance and adaptability The ADVIA 560 System offers the same convenience and safety features of the ADVIA 360 System, with the following capabilities:

Chemistry

• Runs up to 60 samples per hour • Processes aspiration volumes as low as 110 μL

Immunoassay

• Facilitates efficient manual sampling of both open and closed tubes • Measures 26 parameters and employs laser-based optical measurement to provide a 5-part white blood cell differential*

Specialty

• Provides storage capacity of up to 100,000 results • Aids in interpreting disease-state information with two scattergrams and two histograms per result

ESR Blood Gas

ADVIA 560 AL System with Autoloader

A true “walk-away” system For even greater workflow efficiency, the ADVIA 560 AL System streamlines automated sampling. The autoloader simply plugs into the side of the system and provides even more convenient features, including: • 100 primary sample tube capacity (10 racks of 10 sample tubes each) • Ability to accept a variety of tubes

Coagulation • Onboard mixing system and cap-recognition sensor to ensure that only cap piercable tubes are mixed and processed

Cardiac

• Integrated bar-code reader for positive sample ID • Flexibility to add the autoloader to any ADVIA 560 System at any time

*Not all parameters are available in the U.S.

LIS/Resources

5

Forms


Lab Portfolio Lab Lead Form

Siemens ADVIA 360/560

HbA1c and Glucose

Lipid Profile • HemaPrep® Automated Blood Smearing System offers simple and consistent creation of blood films • Hematek® 3000 System standardizes semiautomated slide staining • ADVIA 360 System processes up to 60 CBCs and 3-part differentials per hour • ADVIA 560 System processes up to 60 CBCs and 5-part differentials per hour • ADVIA 560 AL System automates processing of CBCs and 5-part differentials

Siemens scalable hematology systems offer the right fit for you The Siemens family of hematology systems offers a systematic, end-to-end approach specifically designed to adapt to your changing needs. Our scalable system portfolio enables laboratories of all sizes to benefit from reliable, easy-to-use, and cost-efficient hematology solutions. From manual staining to fully automated slide creation, staining and analysis, we have a solution to meet your needs. Our broad portfolio is adaptable enough to support even the largest laboratory, offering track-based automation and multidisciplinary connectivity, with integrated chemistry, immunoassay, hemostasis, and hematology testing systems.

• CellaVision® Image Capture System streamlines the process of finding, focusing, and transmitting digital cell images • CellaVision DM1200 Digital Microscopy System preclassifies cells and offers a review rate of up to 20 slides per hour • CellaVision DM9600 Digital Microscopy System preclassifies cells and offers a review rate of up to 35 slides per hour • ADVIA 2120i System automates the processing of up to 120 CBC/Diff samples per hour • ADVIA Autoslide System streamlines automated, reflexive, slide-making and staining • Aptio Automation enables multi-disciplinary connectivity, including hematology and hemostasis ™

Medline POC Influenza A & B / RSV

Strep

Additional POC

Siemens Range Urinalysis of Hematology Systems

HemaPrep Device

Hematology

Hematek 3000 System ADVIA 360 System

Chemistry

STAT L

• • •

ADVIA 560 System ADVIA 560 AL System

Immunoassay CellaVision Image Capture System*

CellaVision DM1200 System

Specialty

CellaVision DM9600 System ADVIA 2120i System

ESR

ADVIA Autoslide Aptio Automation

Blood Gas

With Siemens as your pr Coagulation partner, you enjoy a broa

• Ease of ordering to reduc procurement hassles

Cardiac and compreh • Convenient to enhance productivity

• Industry-leading Siemens unnecessary downtime

LIS/Resources

6

Forms


Lab Portfolio Lab Lead Form

Siemens ADVIA 360/560

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Siemens Range of Hematology Systems HemaPrep Device Hematek 3000 System ADVIA 360 System ADVIA 560 System

STAT Labs

Satellite Labs

Low Workload

• • •

• • • •

• • • •

High Workload

Core Automated Lab

Urinalysis

Backup Systems

• • • • •

• •

ADVIA 560 AL System CellaVision Image Capture System*

Medium Workload

Hematology Chemistry

Immunoassay

CellaVision DM1200 System

CellaVision DM9600 System ADVIA 2120i System ADVIA Autoslide Aptio Automation

• • • •

Specialty

• • • •

With Siemens as your primary diagnostic equipment partner, you enjoy a broad range of benefits including:

Learn more about the entire family of scalable Siemens hematology systems.

• Ease of ordering to reduce accounting and procurement hassles

Visit www.siemens.com/hematology, or contact your local Siemens sales representative.

ESR Blood Gas Coagulation

Cardiac

• Convenient and comprehensive training and education to enhance productivity • Industry-leading Siemens service and support to minimize unnecessary downtime

LIS/Resources *Not available for sale in the U.S. Product availability may vary from country to country and is subject to varying regulatory requirements.

7

Forms


Lab Portfolio Lab Lead Form

Siemens ADVIA 360/560

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis ADVIA, Aptio, HemaPrep,Hematek, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. or its affiliates. CellaVision is a trademark of CellaVision AB. All other trademarks and brands are the property of their respective owners.

Hematology Chemistry

Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Immunoassay

Order No. A91DX-HHS-141519-XC1-4A00 02-2015 | All rights reserved © 2015 Siemens Healthcare Diagnostics Inc.

Specialty

www.siemens

Global Siemens Headquarters Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany

Global Siemens Healthcare Headquarters Siemens AG, Healthcare Henkestrasse 127 91052 Erlangen Germany Telephone: +49 9131 84-0 www.siemens.com/healthcare

Global Division Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591-5005 USA www.siemens.com/diagnostics

ESR Scalabl Offerin Blood Gas

ADVIA 360, A Coagulation

Cardiac LIS/Resources

www.siemens.com/diagnostics

Forms


Lab Portfolio Lab Lead Form

CDS M-Series Hematology Analyzers

The Leading Selling* 3-part diff Hematology Analyzer in the U.S

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Hematology

Multiple Sampling Methods Options to best fit your needs with: Closed Tube, Open Vial, or Autoloader. All include MPA (Micro Pipette Adapter). User-friendly

Touch screen displays and on board step-by-step instruction makes operation easy and adaptable for different users. Zero Daily / Weekly Maintenance

Engineered to eliminate lengthy cleaning procedures and maximize efficiency. Patented Finger Stick Technology

Chemistry

NOW with enhanced usability features with our latest software update that include:

Immunoassay

• Easier Guided Calibration Procedure

Specialty

• Secured Access for Authorized Users • Maintenance Notifications

ESR

• Operator ID Scanning Capability

Blood Gas

One drop of blood is all it takes. With our MPA (micro-pipette adapter), a finger stick sample gives full blood status in less than a minute. Perfect for children and hard to draw patients!

Coagulation

Cardiac LIS/Resources

PN204401A RTBD

Simply take a finger stick sample. Draw blood into the special 20 µl microcapillary tube.

Slide it into the adapter and insert in the analyzer.

Results will display in approx. one minute. No pre-dilution.

Forms


Lab Portfolio CDS M-Series Hematology Analyzers

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Open Vial - 140073

Cap Piercer - 140074

Autoloader - 140075

Influenza A & B / RSV

Model Characteristics Built-in tube mixer

Micro pipette adapter ( MPA)

Maintenance-free shear valve

Pre-dilution mode

Cap-piercing device

Technical Specification– Medonic M-Series

Strep

Additional POC

Urinalysis

Parameters

16, 3 Part Diff.

Throughput

> 60 samples/hour ( Open Tube)

Time to result

< 50 seconds ( Open Tube)

Sampling system

Closed shear valve

Display

LCD color touch screen

Interface port

Ready

QC capabilities

Built-in comprehensive QC package ( includes Levey-Jennings and Xb)

No. of reagents used

2

Auto Hgb Blank

Yes

Blood detectors

Yes

Reagent level sensors

Yes

Warning Flags on abnormalities

Yes

Barcode reader

Yes

Starter kit and printer

Included

Power consumption

100 VA/20 VA on standby

Frequency

50/60 Hz

Dimensions ( H x W x D)

16 x 11.5 x 18 Open, Closed Vial / 17 x 13 x 18 Autoloader

Weight

≤ 40 lbs. Open, Closed Vial/ ≤ 48.5 lbs. Autoloader

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

Boule Diagnostics AB Domnarvsgatan 4 SE– 163 53 Spånga, Sweden

PN204401A RTBD Clinical Diagnostic Solutions, Inc. is the exclusive seller of the Medonic

Coagulation

Cardiac 1800 NW 65th Avenue Plantation, FL 33313 800.453.3328 www.cdsolinc.com

LIS/Resources

hematology analyzers in the U.S. market.

*According to hematology sales data collected by Global Healthcare Exchange LLC., a leading U.S. based Healthcare Business and Data Automation Company for 2015, 2016, 2017, 2018

Forms


Lab Portfolio Diatron Abacus 3CP

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Abacus 3CP 3-PART WBC DIFFERENTIAL ANALYZER

Additional POC

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Diatron Abacus 3CP

HbA1c and Glucose

ANALYZER OVERVIEW

Lipid Profile

Medline POC Influenza A & B / RSV

Strep The Abacus 3CP system is a compact, bench top, 60 test/hour, 3-part WBC differential analyzer with two sampling modes: a cap piercing mode for closed tube sampling and another for open tubes. The Abacus 3CP has a large color touch

screen with an easy to follow, intuitive user interface. The system is an ideal solution for small laboratories, satellite clinics and doctors’ offices that are looking for reliable, safe, accurate and easy to use instrumentation.

BENEFITS AND KEY FEATURES ACCURATE AND PRECISE RESULTS • Proven impedance measurement technology with advanced flagging algorithms • Clog detection and prevention with automatic system cleaning processes • Unique sample rotor USER FRIENDLY AND EASY TO OPERATE • A high resolution touch screen with easy to follow internationally recognized icons • Recording of sample and quality control information is fast and efficient • Information can be uploaded from a USB or QR code with barcode reader • Transfer data using bi-directional LIS connection OPERATOR SAFETY • Cap piercing mode validated for multiple sample tube types e.g. Vacutainer and Venosafe

• Reduced risk of biohazard exposure • Self-cleaning procedures minimize daily maintenance CONFIDENCE • System uses easy to understand warning messages and sample flags • Employs a comprehensive QC SW package • Offers (4 levels) of user access rights / authority levels • Automatically manages on-board reagent status and lot / expiration dates • Designed to use specific Diatron reagents to deliver the highest quality results

Additional POC

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Diatron Abacus 3CP

Lab Lead Form HbA1c and Glucose

Abacus 3CP

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

DIATRON REAGENTS Our systems comprise of two perfectly matched elements: analyzers and reagents. The optimum performance of our analyzer systems is only achieved when our matched reagents are used. Our ISO 13485 certified reagent manufacturing plant is designed to ensure the highest quality standards. All lots of reagent we manufacture are fully validated prior to release on each of our associated instruments for low background

counts, osmolality, pH and other critical parameters. Our diluent reagents contain no azide and our lyse reagents are cyanide free. Our highly stable reagents offer a shelf life of up to 36 months from the date of manufacture and up to 120 days of onboard stability. The combination of Diatron reagents and Diatron analyzers together ensure the best system performance and quality of results.

Additional POC

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Diatron Abacus 3CP

SPECIFICATIONS MEASURING DATA

• Throughput: 60 tests/hour • Parameters: 16 including 3-part WBC differential: WBC, LYM, MID, GRA, LYM%, MID%, GRA%, RBC, MCV, HCT, HGB, MCH, MCHC, PLT, MPV, RDW-CV MEASURING PRINCIPLE

• Volumetric impedance method • Light absorbance for HGB measurement REAGENTS AND SAMPLING SYSTEM Samples

• Sample volume: 100 μl • Sampling method: Open and closed tubes • Calibration: Manual or automatic Reagents

• Environmentally friendly Diluent bulk and Cleaner reagents and cyanide-free Lyse reagent or

QUALITY CONTROL • 24 QC lots • Levey-Jennings graphs • USB and barcode option to load QC target values • Capable to read QR codes for reference input data TECHNICAL FEATURES • Data storage capacity: 10,000 results • Compatibility with many external printers • Interfacing possibilities: USB, LAN (HL7) • Optional external barcode reader • Built-in thermal printer module, 58 mm wide roll paper, full report with histograms

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

USAGE

• Color touch screen operation • Logical/intuitive user interface • User language: English

Additional POC

DIMENSIONS

Urinalysis

• Size (Width x Depth x Height):

• Diatro•ECO Reagent Pack: Up to 145 measurements

HbA1c and Glucose

32 cm x 49 cm x 36 cm 12˝ x 19˝ x 14˝ Weight: 18 kg, 39 lbs

Hematology

Reagents for Abacus 3 CP SAP Cat. No

Cat. No.

Product name

Pack size

10023088/10023037

D1512/D1012

Diatro•Dil-5P/Diatro•Dil-Diff*

20 l

10023114

D2011HK

Diatro•Lyse-Diff with Hardware Key

1l

10023233

D5011

Diatro•Cleaner**

1l

DRP08

Diatro•ECO Reagent Pack • Diatro Dil 6.5 l • Diatro Lyse 200 ml • Diatro Cleaner 250 ml

set

Chemistry

Immunoassay

Specialty

Cleaners for tube decontamination

*

SAP Cat. No

Cat. No.

Product name

Pack size

10023273

D6011

Diatro•Clenz**

1l

10023287

D7011

Diatro•Hypoclean

1l

10023301

D8011

Diatro•Hypoclean CC

100 ml

Either 3 or 5 part diff diluents can be used on the instrument * * Other sizes of reagents are available: D5015 Diatro•Cleaner 5 l D6015 Diatro•Clenz 5 l

Analyzers Description

Catalogue No

SAP Cat. No

Abacus 3CP (US market only)

A3CPC-1

10021777

Abacus 3CT analyzer (International markets)

A3CTC-1

10021802

We are a member of the STRATEC Group www.diatron.com I sales@diatron.com Abacus 3CP is only available in the USA. A similar product called Abacus 3CT is cleared for sale in non-US markets. Diatron reserves the right to change any of the specifications without prior notice.Version Nr. A3CP180619V3

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Diatron Abacus 5

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Abacus 5

5-PART LASER WBC DIFFERENTIAL ANALYZER

Strep

Additional POC

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Diatron Abacus 5

HbA1c and Glucose

ANALYZER OVERVIEW

Lipid Profile

Medline POC Influenza A & B / RSV

Strep The Abacus 5 system is a compact, bench top, 60 test/hour, 5-part laser WBC differential analyzer with two sampling modes: a cap piercing mode for closed tube sampling and another for open tubes. The Abacus 5 can be enhanced to meet your changing needs by adding an autosampler

and / or a small sample volume module. This system is an ideal solution for most hospitals, laboratories and satellite clinics that are looking for more advanced technology which is reliable, safe, accurate and easy to use.

Urinalysis

BENEFITS AND KEY FEATURES ACCURATE AND PRECISE RESULTS • Proven impedance measurement technology • Patented optical laser based WBC differential technology • Clog detection and prevention with automatic system cleaning • Advanced sample aspiration flagging checks FIELD UPGRADEABLE OPTIONS • Autosampler for walk-away capability • Small Sample Module** for reduced sample volume requirement USER FRIENDLY AND EASY TO OPERATE • High resolution touch screen • Recording sample and quality control information is fast and efficient • Information can be uploaded from a USB, QR code or via a bi-directional LIS connection

Additional POC

OPERATOR SAFETY • Cap piercing mode validated for several sample tube types e.g. Monovette, Vacutainer, Vacuette • BD MAP tube can be used if small sample module fitted • Self-cleaning minimizes daily maintenance • Reduced risk of biohazard exposure CONFIDENCE • Simple warning messages and sample flags • On-board comprehensive QC SW package • Offers (3 levels) of user access rights / authority levels • Automatically manages on-board reagent status and lot / expiration dates SPECIFICALLY MATCHED REAGENTS • Designed to use specific Diatron reagents to deliver the highest quality results • Maximum shelf life of 36 months with up to 120 day on-board stability

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources ** Only available in non US markets

Forms


Lab Portfolio Lab Lead Form

Diatron Abacus 5

HbA1c and Glucose

Abacus 5

Lipid Profile

Medline POC Influenza A & B / RSV

Comparative study data with leading commercial analyzer from three independent laboratories

Strep Scatter Plot with Deming Fit

90

Scatter Plot with Deming Fit

8

80

Additional POC

7

70

6

Urinalysis

50

RBC - A5

WBC - A5

60

40

Identity

4

Identity

Allowable bias (0.3 or 6%)

30

Allowable bias (0.15 or 6%)

Deming fit (0.05 + 0.98x)

Deming fit (0.03 + 0.99x)

3

95% CI bands

20

0

20

40 WBC - CD3700

60

1

80

Chemistry 1

2

3

WBC

4 5 RBC - CD3700

6

7

8

Immunoassay

RBC

Specialty

Scatter Plot with Deming Fit

Scatter Plot with Deming Fit

1200

Hematology

95% CI bands

2

10 0

5

25

1000

ESR

20

800

Identity Allowable bias (15 or 8%)

400

Blood Gas Identity

10

Allowable bias (0.3 or 6%) Deming fit (-0.17 + 1.02x)

Deming fit (-1.48 + 1.04x) 95% CI bands

200

0

HGB - A5

PLT - A5

15

600

0

200

400

600 PLT - CD3700

PLT

800

1000

1200

95% CI bands

5

0

0

5

10 15 HGB - CD3700

20

25

Coagulation

Cardiac

HGB

Additional clinical performance data is available in the A5 case history study.

LIS/Resources

Please ask your distributor or contact Diatron (www.diatron.com) for further information.

Forms


Lab Portfolio Lab Lead Form

Diatron Abacus 5

SPECIFICATIONS MEASURING DATA • Throughput: 60 tests/hour • Parameters: CBC+5 DIFF mode, 2 histograms: RBC, PLT, 2 scattergrams: 4 diff, BASO, 26 parameters: WBC, LYM, MON, NEU, EOS, BAS, LYM%, MON%, NEU%, EOS%, BAS%, RBC, HCT, MCV, RDW-sd, RDW-cv, HGB, MCH, MCHC, PLT, PCT*, MPV, PDW-sd*, PDW-cv*, P-LCC*, P-LCR* MEASURING PRINCIPLE

• Laser light scatter technology • Impedance method for CBC • Light absorbance for HGB measurement

HbA1c and Glucose

TECHNICAL FEATURES • Multilevel user modes with individual identification • Data storage capacity: 100,000 records • Printout: External printers USAGE • User interface: LCD touch screen (10.4˝) • Multilingual user interface English, French, Spanish, Croatian, Hungarian, Italian, Polish, Portuguese, Russian, Turkish, Chinese, German, Greek

Lipid Profile

Medline POC Influenza A & B / RSV

DIMENSIONS

• Size (Width x Depth x Height)

REAGENTS AND SAMPLING SYSTEM Samples • Sample volume: 110 μl of whole blood • Closed and open tube sampling • Calibration: Stat and Autosampler mode, specific control material (external reference – optional) • Pre-dilute software option for small samples Reagents • Environmentally friendly Diluent and Cleaner reagents and cyanide-free Lyse QUALITY CONTROL • Separate QC database

• Levey-Jennings graphs

Strep

40 cm x 50 cm x 45 cm 16˝ x 20˝ x 18˝ Weight: 35 kg, 77 lbs

OPTIONS Autosampler • Sample capacity: 100 tubes with continuous loading • Acceptable primary tubes - Greiner, Monovette, Terumo, Vacuette, Vacutainer • Built-in barcode reader and sample mixer • Cap recognition Small sample module * • Aspirated sample only 25 μl (standard 110 μl) *

Additional POC

Urinalysis

Hematology

Parameter/feature not available in the US

Chemistry

Analyzers and Upgrade kits

Immunoassay

Reagents for Abacus 5

Description

Catalogue No

SAP Cat. No

SAP Cat. No

Cat. No.

Product name

Pack size

Abacus 5 with sample tube cap piercing

A5-1

10021849

10023088

D1512

Diatro•Dil-5P

20 l

Abacus 5 with Autosampler module

A5AS-1

10022017

10023190

D3015HK

Diatro•Lyse-5P with Hardware Key

5l

Abacus 5 with Small Sample Volume module

A5SSM-1

10022045

10023204

D3021

Diatro•Diff-5P

1l

Small Sample Volume module - Upgrade kit (for units pre 5/13)

10023301

D8011

Diatro•Hypoclean CC

100 ml

A5SSM-Kit

Small Sample Volume module - Upgrade kit (fur units post 4/13)

A5SSM01-Kit

10033068

Autosampler module - Upgrade kit

AS5-1

10022494

Specialty

ESR

10030744

Blood Gas Coagulation

Cardiac We are a member of the STRATEC Group I www.diatron.com I sales@diatron.com Abacus 5 is available for sale in all markets-US and non-US.

LIS/Resources

Version Nr. A5190528V9

Forms

Diatron MI Zrt makes best efforts to provide accurate information and specifications herein, whereby it may be possible for omissions or errors to have occurred. Diatron MI Zrt shall have no liability for the accuracy and completeness of the information and cannot be held liable for any representations or warranties, expressed or implied, and any third party claims or losses of any damages. Diatron MI Zrt reserves the right to make any changes to the information, including specifications, without notice. The applications and products herein may not be available in all markets. ©2019, Diatron MI Zrt, Hungary, all rights reserved.


Lab Portfolio Horiba Micros 60

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Horiba Micros 60

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Horiba Micros 60

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Horiba Micros 60

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Beckman Coulter DxH 520

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Hematology Chemistry

DxH 520 5-part differential closed tube hematology analyzer

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Beckman Coulter DxH 520

Lab Lead Form HbA1c and Glucose

Profile DxHLipid 520 HEMA

Minimum footprint. Medline POC

The new closed tube 5-p come in small packages

Influenza A & B / RSV

Spend more time on patient c

520 closed tube hematology a

DxH 520 closed tube system, l Strep

as 375 µL microtainer fill-volum

Experience safety without com

provides optimal security Additional POC agai

Laboratories can enhance ope

types and accommodate cap-

streamlines the analysis of pun Urinalysis

critical-care patients. Laborato

even smaller draws and non-ca

Provide Hematology comprehensive care w

most precious patient samples

differential testing with ease, u

blood. This is ideal for pediatri Chemistry sample volumes at collection.

using less blood and without c

Immunoassay

› The DxH 520 enables la • Maximize laboratory

Specialty

productivity

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Beckman Coulter DxH 520

HbA1c and Glucose

Lipid Profile

DxH 520 HEMATOLOGY ANALYZER Minimum footprint. Maximum productivity.

Medline POC

The new closed tube 5-part differential analyzer—because great things come in small packages Spend more time on patient care and less on operational tasks with the powerful, compact DxH

Influenza A & B / RSV

520 closed tube hematology analyzer, the latest in a legacy of low-volume solutions. With the DxH 520 closed tube system, laboratories can deliver critical first results accurately, with as little as 375 µL microtainer fill-volume and an aspiration of only 17 µL.

Strep

Experience safety without compromise by using closed tube technology. The DxH 520 analyzer

Additional POC

provides optimal security against blood-borne pathogens due to its closed tube aspiration. Laboratories can enhance operational flexibility by selecting from an extensive number of tube types and accommodate cap-pierceable microtainers, such as MAP tubes. The system

Urinalysis

streamlines the analysis of puncture samples from infant, child, geriatric, oncology and critical-care patients. Laboratories can also choose the open tube mode for even smaller draws and non-cap-pierceable collection tubes.

Hematology

Provide comprehensive care with less than a drop of blood to test the most precious patient samples. Technologists can perform 5-part differential testing with ease, using just a finger-prick amount of

Chemistry

blood. This is ideal for pediatric patients, who routinely provide small sample volumes at collection. Tests can be added or repeated while using less blood and without collecting another sample.

Immunoassay

› The DxH 520 enables laboratories to: • Maximize laboratory productivity

• Reduce overall operating costs

• Deliver high-quality

Specialty

clinical results

ESR Blood Gas Coagulation

Cardiac LIS/Resources 3

Forms


Lab Portfolio Lab Lead Form

Beckman Coulter DxH 520

HbA1c and Glucose

MAXIMIZE LABORATORY PRODUCTIVITY

Optimize laborat Lipid Profile

The DxH 520—designed for high reliability—delivers automated tasks, efficient reagent usage,

› Achieve fast analys

easy reagent replacement, and powerful patient and QC data-management tools. All of this

Simplify work processes Medline POC

means increased productivity and maximum uptime for laboratories.

powerful software, help

Enhance uptime and system maintenance

› Ensure uptime with proven system reliability

CreateAvaluable Influenza & B / RSVspa

Maximize available spac

does not require a sepa

Strep the flexibilit laboratories

Know that results will be delivered precisely when needed. A global, multisite reliability study of the analyzer’s platform, using more than 36,000 samples, showed an emergency service-call rate of less than one call per year. With high reliability and a low number of operational tasks, the DxH 520 analyzer is able to achieve an uptime rate greater than 98.5%.

› Discover task automation

patient, for example—to

Additionalany POCcomma › Execute

Learn how to use the sy

software. Complete any

Urinalysis

functions quickly from a

Apply the programmable power-up and start-up features with background checks. Users are able to set the system to activate automatically, before the beginning of a shift, so it is ready to work when they arrive. Cleaning can also be programmed and automated to minimize

Hematology

daily maintenance.

› Benefit from quick and infrequent reagent

Chemistry

replacement Use only three reagents, requiring only five minutes or

Immunoassay

less for replacement, to keep analysis running smoothly throughout the day. Each reagent can be changed out individually in less than two minutes.

Specialty

ESR 406 mm (16.0 in.)

Designed for uptime

Blood Gas

Greater than 98.5% uptime (analysis based on global reliability study)

>98.5% uptime

Coagulation

Cardiac LIS/Resources

4

Forms


Lab Portfolio Lab Lead Form

Beckman Coulter DxH 520

HbA1c and Glucose

Optimize laboratory performance

Lipid Profile

› Achieve fast analysis—in 60 seconds or less Medline POC

Simplify work processes and allow rapid turnaround of specimens with intuitive and powerful software, helping to minimize patient wait times.

› Create valuable space

Influenza A & B / RSV

Maximize available space with an analyzer that is smaller than a standard microwave and does not require a separate PC or monitor. The DxH 520 analyzer’s compact design gives

Strep

laboratories the flexibility to place instrumentation in optimal locations—closer to the patient, for example—to create a leaner workflow for greater efficiency.

› Execute any command in three touches or less

Additional POC

Learn how to use the system in less than one hour due to the DxH 520 analyzer’s intuitive software. Complete any system operation in three steps or less and access all major

Urinalysis

functions quickly from any screen.

Hematology Chemistry

270 mm (10.6 in.)

Immunoassay

Specialty

ESR 406 mm (16.0 in.)

Blood Gas Coagulation

Cardiac LIS/Resources

5

Forms


Lab Portfolio Lab Lead Form

Beckman Coulter DxH 520

HbA1c and Glucose

Improve data and quality control management

› Gain powerful patient data-management tools

REDUCE OVER Lipid Profile The efficiently designed DxH

• Reduce clerical errors, inefficiencies and risk with a bidirectional interface

Medline POC non-toxic reagents and low p

• Expand sample storage capacity—up to 30,000 patient samples—for easy delta checks

bottom line.

and file retrieval • Upload records quickly and easily with a front-side USB connection port • Ensure patient privacy and security with customizable user login and automated timeouts with full traceability

› Achieve trusted performance with a robust QC management-tool package • View Levy-Jennings limits and quality control (QC) results with easy-to-interpret graphs • Access online peer-review expertise and support • Upload new QC lot details with an easy-to-use handheld barcode reader • Automate daily checks and keep up to 50 data points stored for easy viewing • Expand QC monitoring with additional techniques, such as the XM, XB and eQC methods

Influenza A & B / RSV Preserve valuable r

reagent usage › Reduce Strep

Use 50% less reagent volum reagent bottle can support

Additional POC

› Lower the cost of disp

Utilize cyanide-, azide- and

Urinalysis as helping to meet environm

› Optimize power consu

Hematology Consume less power by usi

energy light source promot Patient result screen

Easy backup to restore patient test results, QC reports and consumable event logs

supply, which regulates volt

Chemistry

Immunoassay

Specialty

ESR Preprogrammed daily and background checks

Easy-to-read QC charts

Blood Gas Coagulation

Cardiac LIS/Resources

6

Forms


Lab Portfolio Beckman Coulter DxH 520

Lab Lead Form HbA1c and Glucose

REDUCE OVERALL OPERATING COSTS

Lipid Profile

The efficiently designed DxH 520 can reduce overall operating costs through the use of

Medline POC

non-toxic reagents and low power consumption for efficient management of the laboratory’s bottom line.

Influenza A & B / RSV

Preserve valuable resources

› Reduce reagent usage

Strep

Use 50% less reagent volume per sample, compared to other low-volume analyzers. A single reagent bottle can support hundreds of tests.

Additional POC

› Lower the cost of disposal Utilize cyanide-, azide- and formaldehyde-free reagents, reducing the cost of disposal as well as helping to meet environmental and regulatory compliance standards.

Urinalysis

› Optimize power consumption Hematology

Consume less power by using fewer moving parts and energy-efficient components. A lowenergy light source promotes longer life, and a highly reliable auto-voltage-switching power supply, which regulates voltage fluctuations.

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources

7

Forms


Lab Portfolio Lab Lead Form

Beckman Coulter DxH 520

HbA1c and Glucose

DELIVER HIGH-QUALITY RESULTS

Improve flaggin Lipid Profile sensitivity — wit

The DxH 520 low-volume system provides accuracy through Coulter Principle technology and

confidenc › Improve Medline POC

Axial Light Loss (ALL) for a white blood cell (WBC) differential. Proprietary dynamic gating increases the automated differential accuracy, delivering more reportable results with less unnecessary flagging. Hemoglobin is read accurately using the cyanide-free oxyhemoglobin methodology at 545 nm. Counting and sizing is performed in duplicate, also using the Coulter Principle, for greater precision.

proprietary dynam

Take advantage of sop

Influenza A & Bby / RSV populations adjustin

dynamic-gating techno gates, unlike the static

Apply optical analysis—Axial Light Loss (ALL)—and Coulter Principle innovation to WBC testing

› Combine ALL and Coulter Principle technologies to complete an accurate

Strepproprietary m Coulter’s

in a series of steps (Fig

populations, such as ly

Additional differential POC than static

leukocyte differential Gain accurate cellular information, measured by preserving cells in their native states. The DxH 520 analyzer does not alter blood cells through staining, shrinkage or WBC lysis, which can induce fragility in the cells and distort results (Figures 1a and 1b). The digital information obtained from the WBC blue LED analysis is processed through the WBC differential

Urinalysis

Figure 2a: Static-gatin

Hematology

algorithm. This information is represented on a 2D scatter plot, according to Coulter Principle volume, plotted on the Y-axis and ALL.1 Users can easily identify cells by color.

Figure 1a: Optimal measurement zone

Figure 1b: Optimal cell pulses identified

Chemistry

Immunoassay

Specialty

ESR

› Reduce unnecessa gating techniques Blood Gas Achieve less flagging,

agreement with manua

Coagulation

Cardiac LIS/Resources

8

Forms


Lab Portfolio Lab Lead Form

Beckman Coulter DxH 520

HbA1c and Glucose

Improve flagging while maintaining effective clinical sensitivity — with proprietary dynamic-gating technology

Lipid Profile

› Improve confidence in the accuracy of the leukocyte differential with

Medline POC

proprietary dynamic-gating technology compared to a static gate Take advantage of sophisticated gating technology that improves the identification of cell

Influenza A & B / RSV

populations by adjusting the thresholds between cell-cluster arrangements. The unique dynamic-gating technology in the DxH 520 analyzer provides multiple layers of adjustable gates, unlike the static or simple dynamic gates available in other technologies. With Beckman Coulter’s proprietary method, the gates move to more proper cutoffs between cell clusters

Strep

in a series of steps (Figures 2a and 2b). Improvement is seen in more challenging cell populations, such as lymphocytes and eosinophils, giving a more accurate leukocyte

Additional POC

differential than static gating.

Urinalysis Figure 2a: Static-gating technology

Figure 2b: Dynamic-gating technology

Hematology Chemistry

Immunoassay

Specialty

ESR

› Reduce unnecessary flagging, compared to static- or less-effective gating techniques

Blood Gas

Achieve less flagging, while maintaining effective clinical sensitivity, and achieve excellent agreement with manual slide reviews and good predicative values.

Coagulation

Cardiac LIS/Resources

9

Forms


Lab Portfolio Lab Lead Form

Beckman Coulter DxH 520

Secure quality CBC results and eliminate guesswork

› Provide fast, accurate CBC analysis using the Coulter Principle and digital pulse processing Achieve accurate WBC, red blood cell (RBC), and platelet counting and sizing with the proprietary Coulter counting method (Figure 3). Digital pulse processing enables the recognition of data points that fall outside the optimal counting zone. Removing these unreliable data points enhances count accuracy (Figures 1a and 1b). Quality results are further improved with dual-count apertures and a wider linearity range for a more comprehensive patient-care experience.

HbA1c and Glucose DxH 520 Hematol Mode ofLipid Operation Profile Sample Volume

17 μ 20 μ

Throughput

55 c

Menu/Test Parameters

WB MO

RUO Parameters

IMM

Medline POC

Influenza A & B / RSV 30,0

Data Storage

User Interface

Figure 3: Coulter impedance for size and counting

VACUUM Electrolyte (~50 ohm/cm)

Aperture (~50 ooo ohm/cm)—R=pxl/s Electrode

Detection area

Ope

eac

Tou

Strep Power Requirements

100

Power Consumption

Les

Operational Ambient Temperature Additional POC

18–3

Humidity

80%

Altitude

Up

External Urinalysis Storage

Sup

LIS

Sup

Printer

Opt

Languages

Hematology

Cze

Weight and Dimensions

2

Chemistry VOLT

Ordering Information Proportional height to the cell volume—U=RxI

DxH 520 Hematology Analyzer

Immunoassay

DxH 520 Diluent (10 L each) Voltage impulse on the electrode terminal Electric threshold

DxH 520 Lyse (500 mL each)

Specialty

TIME

Couting Impulse

ESR Blood Gas

DxH 520

DxH

Low-volume Mediu Up to 60Coagulation samples/hour Up to 100

Cardiac LIS/Resources

* Basophil count and percent value must be reflexed for manual micr † For Investigational Use Only. The 10

Forms


Lab Portfolio Lab Lead Form

Beckman Coulter DxH 520

HbA1c and Glucose

DxH 520 Hematology Analyzer Specifications Lipid Profile

Mode of Operation

Open and closed tube sampling

Sample Volume

17 μL of venous or micro-collected whole blood 20 μL of whole blood for pre-diluted analysis

Throughput

55 closed tube samples per hour, 60 open tube samples per hour

Menu/Test Parameters

WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-SD, RDW-CV, PLT, MPV, LY%, LY#, MO%, MO#, NE%, NE#, EO%, EO#, BA%, BA# *

RUO Parameters

IMM%, IMM#, LHD, MAF, PCT, PDW

Data Storage

30,000 patient results, including graphics, flags, codes and messages; 12 control files, each with a maximum of 150 runs

User Interface

Touch screen; Handheld barcode scanner

Power Requirements

100–240 VAC 50–60 Hz/Single phase with ground

Power Consumption

Less than 120W

Operational Ambient Temperature

18–32°C (64.4–89.6°F)

Humidity

80% relative humidity (non-condensing) at 32°C (89.6°F)

Altitude

Up to 3,000 meters (9,843 feet)

External Storage

Supports USB 2.0 (five ports)

LIS

Supports serial (RS-232) and Ethernet communication

Printer

Optional USB printer

Languages

Czech, English, French, German, Iberian Portuguese, Italian, Japanese, Romanian, Spanish

Weight and Dimensions

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Width

Height

Depth

Weight

270 mm (10.6 in.)

406 mm (16.0 in.)

430 mm (16.9 in.)

11.4 kg (25.1 lbs.)

Hematology Chemistry

Ordering Information

Part Number

Ordering Information

Part Number

DxH 520 Hematology Analyzer

B40602

DxH 520 Cleaner (500 mL each)

B36868

DxH 520 Diluent (10 L each)

B36845

DxH 520 Calibrator (2 x 2.0 mL)

B36880

DxH 520 Lyse (500 mL each)

B36846

DxH 520 Control (6 x 2.3 mL, tri-level sets)

B36872

Immunoassay

Specialty

ESR

DxH 520

DxH 690T†

DxH 900

DxH 900-2S

Blood Gas

DxH 900-3S

Low-volume Medium-volume Medium- to high-volume High-volume Ultra-high-volume Up to 60 samples/hour Up to 100 samples/hour Up to 100 samples/hour Up to 200 samples/hour Up to 300 Samples/Hour

Coagulation

Cardiac LIS/Resources

* Basophil count and percent values may be under reported, all numerical results reported for these parameters must be reflexed for manual microscopy OR followed up for additional testing based on the laboratory’s SOP. † For Investigational Use Only. The performance characteristics of this product have not been established. 11

Forms


Lab Portfolio Beckman Coulter DxH 520

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas Enhance your laboratory operations and improve patient care with our hematology solutions. Visit www.beckmancoulter.com/hematology

1. Beckman Coulter. DxH 520 Instructions for Use v2.

© 2019 Beckman Coulter, Inc. All rights reserved. Beckman Coulter, the stylized logo and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.

Coagulation

Cardiac LIS/Resources

For Beckman Coulter’s worldwide office locations and phone numbers, please visit www.beckmancoulter.com/contact BR-183312

Forms


Lab Portfolio Beckman Coulter DxH 600/800

Lab Lead Form HbA1c and Glucose

Lipid Profile

DxH 800 and DxH 600 Cellular Analysis Systems

TECHNOLOGY ADVANCEMENTS IN CBC METHODOLOGY

Medline POC Influenza A & B / RSV

Strep

Introduction Complete blood count (CBC) is a fundamental analytical test that evaluates three main cellular components: white blood cells (WBCs), red blood cells (RBCs) and platelets (PLTs). The DxH 800 and DxH 600 analyzers incorporate innovative electronic and mechanical designs that, in conjunction with advanced algorithms, improve system performance and uptime. These designs and algorithms also work together to enhance the sensitivity and resolution of cell counting at critical decision levels for the analysis of whole blood and body fluids samples, providing the highest quality patient results.

The DxH 800 and DxH 600 CBC Processes The DxH 800 and DxH 600 CBC modules perform both sample preparation and management. WBC, RBC and PLT cellular triple aperture counts and volumes, as well as hemoglobin (HGB) measurement information, are processed and provided in digital format by the advanced DxH 800 and DxH 600 algorithms. The CBC algorithms have four analysis modules, one each for WBCs, RBCs, PLTs and HGB. The WBC, RBC and PLT algorithms utilize digital count and size information to:

› › › ›

Perform coincidence correction Calculate individual aperture and average parameter counts Generate individual and average parameter histograms Perform count and histogram voting

The advanced algorithms then analyze WBC, RBC and PLT histograms for interferences and automatically correct or flag the results. DataFusion, which is a proprietary capability that incorporates hardware technology and advanced software analyses, enhances flagging confidence. It generates cellular information from the CBC, differential, optical NRBC scatter and reticulocyte modules to identify interferences, enhance result confidence and help ensure superior CBC results.

Additional POC

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Beckman Coulter DxH 600/800

HbA1c and Glucose DxH 800 and DxH 600 Design and Technology Mechanical Features

› › › ›

WBC and RBC aperture baths prevent mixing bubbles

Electronics

Proprietary reagent pumps reduce micro-bubble and debris formation

New instrument control circuitry:

• Provides advanced fault detection and recovery with Intelligent

Solid-state diluter design decreases tubing and eliminates pinch valves

Quality Monitoring (IQM)

• Optimizes system availability • Provides real-time system monitoring for all analyzer functions Proprietary high-speed, high-resolution analog to digital conversion

• Digital Signal Processing • Unique digital pulse processor • Multiple parameter measurements on each cell event • Utilization of data extraction circuitry for maximum data-

Increased shielding and grounding result in lower background counts for body fluids analysis

These features improve accuracy and precision, eliminate interferences and provide low background counts for body fluid analysis.

Lipid Profile

processing efficiency

• Maintained stability over time and temperature variations • Modular design for optimized cellular analysis circuitry, which saves space and improves accessibility

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Hematology

Chemistry

Immunoassay Advanced Algorithms

Powerful DxH 800 and DxH 600 CBC algorithms utilize the enhanced digital pulse characteristics for additional cellular measurements

•Automatically corrects for WBC interference in all CBC parameters •Provides enhanced detection of WBC, RBC and PLT interferences System Performance

› › ›

Specialty

ESR Blood Gas

Extended measuring ranges for WBCs, RBCs and PLTs Lower background limits for body fluids analysis Environmentally friendly reagents

© 2017 Beckman Coulter, Inc. All rights reserved. Beckman Coulter, the stylized logo and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and o ther countries. For Beckman Coulter’s worldwide office locations and phone numbers, please visit www.beckmancoulter.com/contact

Coagulation

Cardiac LIS/Resources

DS-52349

Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

Chemistry Abbott Point of Care Piccolo Xpress

Lipid Profile Medline POC

Abbott Point of Care i-STAT

Siemens Dimension EXL Family + Test Menu

Alfa Wassermann ACE Axcel

Strep

Reliable. Accurate. Results.

Welcome to the

POINT OF CARE

POINT OF CARE

The Smart Choice

L-TIME CHEMISTRY. REAL-WORLD BENEFITS.

Uniquely designed to meet the needs of the POL, the ACE Axcel has been cleared by the FDA specifically for use in Physician Office Labs.

mize efficiency and productivity with fast, accurate, on-site testing

decisions with confidence with lab-accurate results

ain compliance with automated quality control features

se patient satisfaction by reducing the need for call-backs

Reliable. Accurate. Results.

For over a decade, Alfa Wassermann has received the NorthFace ScoreboardSM Award for Excellence in Customer Satisfaction. An objective benchmark for service and support, the NorthFace Award represents the true voice of the customer.

a range of testing needs with a single, versatile platform

AD CLINICAL APPLICATIONS.

Xpress® meets a wide range of clinical testing needs across a variety of healthcare and specialties.

ent Care

• Primary/Family Care

• Pediatrics

rnal Medicine

• Long-Term Care

• Ambulatory Surgery

diology

• Oncology

• Dermatology

Alfa Wassermann is the market leader in clinical chemistry systems for the Physician Office Laboratory. We take pride in providing the highest level of customer service. We listen. We care. And it shows. Your Alfa Wassermann team includes a nationwide network of company-trained engineers and support personnel who provide 24/7 technical support. We bring more than 35 years of manufacturing and service excellence to build and support market-leading clinical chemistry systems.

pital Clinics

LAB-ACCURATE TESTING WITHOUT THE WAITING.

SMART LAB

Over A Decade of Award-Winning Customer Service

Now, through Alfa Assist™, we enhance your user experience. Web-enabled, remote access facilitates

Alfa Wassermann analyzers help you: • Screen for diseases • Diagnose and treat sooner • Monitor progress and adjust treatments as necessary

FOR IN VITRO DIAGNOSTIC USE ONLY consultative support and educational services. proactive,

For more information or to schedule a demo, please call 1-800-220-4488 or visit www.AlfaWassermannUS.com. i-STAT SYSTEM TEST CARTRIDGES

• Easy to use—Fully automated system makes testing fast and simple for staff

AVA I L A

Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

SM462 Rev 3 10/15

Order No. A91DX-CAI-140978-GC1-4A00 06-2015 | All rights reserved © 2015 Siemens Healthcare Diagnostics Inc.

Meet expanding needs with a proven, integrated system. The Dimension EXL family of systems offers you a choice of solutions with our patented LOCI technology inside. www.siemens.com/diagnostics

• Flexible connectivity—Capable of bi-directional interfacing Rev. A 07/16. Piccolo Xpress®, Piccolo® and iQC® are registered trademarks of Abaxis, Inc. Abaxis Part Number 888-3293 Rev. A.

N™

ointofcare.com

ACE Axcel® Clinical Chemistry System

Global Siemens Headquarters Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany

B

L

U

4 Henderson Drive West Caldwell, NJ 07006 Tel: 1-800-220-4488 www.AlfaWassermannUS.com info@alfawassermannus.com

CentraLink, Dimension, Emit, EXL, FLEX, LOCI, QuikLYTE, Syva, VersaCell, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. or its affiliates. All other trademarks and brands are the property of their respective owners.

WITH LAB- QUALITY RESULTS IN MINUTES

E

The Smart Choice for POLs

N

E

n more about how the Piccolo Xpress can transform your practice, contact bbott Point of Care Representative, or visit www.abbottpointofcare.com

M

• Maintain control and compliance—Automated quality control checks on every test

ASSAYS TO MEET A WIDE RANGE OF CLINICAL NEEDS

MPREHE CO

VE SI N

• Accuracy you can trust—Lab-accurate results enable clinicians to make decisions with confidence

MOS T

TRANSFORM YOUR EFFICIENCY WHILE MAINTAINING QUALITY AND COMPLIANCE.

Additional POC

In today’s competitive environment, we recognize that operating a successful and cost-effective practice requires diagnostic testing that is smart, fast, reliable, and accurate. ACE Axcel is the intelligent choice for your smart lab.

Alfa Wassermann Diagnostic Technologies

• Test results in minutes—Clinicians have results during a patient visit, accelerating treatment decisions and avoiding call-backs and follow-up visits

Influenza A & B / RSV

Black Diagonal lines do not print. Just F.P.O. for Busines card slits

Global Siemens Healthcare Headquarters Siemens AG, Healthcare Henkestrasse 127 91052 Erlangen Germany Telephone: +49 9131 84-0 www.siemens.com/healthcare

Urinalysis

Global Division Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591-5005 USA www.siemens.com/diagnostics

Magenta Rule does not print. JUst indicates the trim. Final Flat size should be 28" wide x 8.5" high. Pocklet should be large enough to fite insert cards(5.5" wide x 8" high) into. Also gets business card slits on pockket.

www.siemens.com/diagnostics

Answers for life.

Hematology Atellica Solution + Test Menu

Beckman Coulter Chemistry Analyzes

Horiba Pentra 400 Chemistry Analyzer

Medtest BS-200 Chemistry Analyzer

Chemistry

ptio, Atellica, Atellica Magline, and all associated marks e trademarks of Siemens Healthcare Diagnostics Inc. its affiliates. All other trademarks and brands are the operty of their respective owners.

oduct availability may vary from country to country d is subject to varying regulatory requirements. ease contact your local representative for availability.

mens Healthcare Diagnostics Inc., 2018

Immunoassay

Take control. Simplify lab operations.

Drive better outcomes.

The Atellica® Solution: flexible, scalable, automation-ready immunoassay and chemistry analyzers

Inc.

siemens.com/atellicasolution

TIMELY RESULTS, TIME-PROVEN TECHNOLOGIES ONE SYSTEM BRINGS IT ALL TOGETHER DxC 700 AU Chemistry Analyzer

Specialty

ESR Diatron Pictus 500

Diatron Pictus 700

Blood Gas P500

Pictus 700

INTELLIGENT WALK AWAY CHEMISTRY

THE SMART CHOICE FOR TODAY’S LABORATORY

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Abbott POC Piccolo Xpress

HbA1c and Glucose POINT OF CARE Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology

LAB-ACCURATE TESTING WITHOUT THE WAITING.

Chemistry Chemistry Immunoassay

• Flexible connectivity—Capable of bi-directional interfacing

Blood Gas

E

N

E

• Easy to use—Fully automated system makes testing fast and simple for staff

M

• Maintain control and compliance—Automated quality control checks on every test

ESR

MPREHE CO

U

B

L

• Accuracy you can trust—Lab-accurate results enable clinicians to make decisions with confidence

Specialty

VE SI N

• Test results in minutes—Clinicians have results during a patient visit, accelerating treatment decisions and avoiding call-backs and follow-up visits

MOS T

TRANSFORM YOUR EFFICIENCY WHILE MAINTAINING QUALITY AND COMPLIANCE.

AVA I L A

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Abbott POC Piccolo Xpress

ACCELERATE TESTING. ASSURE COMPLIANCE. • Accuracy and precision comparable to larger laboratory analyzers • iQC® system performs continuous quality control checks on every run, helping maintain compliance while eliminating daily control testing requirements • Fully automated system—minimal testing experience required • Small blood sample—just 100 μL of whole blood, serum, or plasma

HbA1c and Glucose

FROM SAM

Lipid Profile A 2014 study in the American Journal of Clinical Pathology1 found that point-of-care testing significantly improved clinical operations, resulting in: • 21% reduction in tests ordered • 89% reduction in follow-up phone calls • 85% reduction in follow-up letters • 61% reduction in follow-up visits • Practice efficiency cost savings totaling $24.64/patient2

Medline POC Influenza A & B / RSV

Strep

Step 1: Add sample Additional POC

MONITOR A RANGE OF PARAMETERS WITH ONE, EASYBUN Ca CICRE GLU

07P02-04

Lipid Panel

Lipid Panel Plus

Liver Panel Plus

CHOL CHOL/HDL* nHDLc* HDL LDL* TRIG VLDL*

ALT AST CHOL CHOL/ HDL*

07P02-05

07P02-12

07P02-10

General Chemistry 6

General Chemistry 13

Electrolyte Panel

GGT GLU eGFR*

TS

IN

UTE R

UL

E AVA I L A

ALT AST BUN CRE

B

L

E

U

12-M

M

N

VE SI N

MOS T

Basic Metabolic Panel

GLU ALB K+ ALP Na+ ALT TBIL AST tCO2 BUN Ca TP CIeGFR* CRE 07P02-08

ES

ALB ALP ALT AMY AST BUN Ca

nHDLc* GLU HDL LDL* TRIG VLDL*

CRE GGT GLU TBIL TP UA eGFR*

ALB ALP ALT AMY

K+ Na+ tCO2 eGFR*

AST GGT TBIL TP

ClK+ Na+ tCO2

07P02-02

Kidney Check

Renal Function Panel

MetLyte 8 Panel

BUN CRE eGFR*

ALB BUN Ca ClCRE GLU

BUN CK ClCRE GLU

07P02-07

IN

Chemistry MetLyte Plus CRP

K+ BUN Immunoassay CK ClCRE GLU

Na+ tCO2 CRP eGFR*

07P02-14

ESR Blood Gas

07P02-11

07P02-09

Complex Panels

Specialty

07P02-01

K+ Na+ PHOS tCO2 eGFR*

Hematology Moderately

12-M

Comprehensive Metabolic Panel

MPREHE CO

Urinalysis

K+ Na+ tCO2 eGFR*

07P02-03

Coagulation Cardiac

*Calculated. Note: Each panel comes LIS/Resources 1. Crocker, J et al, Implementation of P Am J Clin Pathol November 2014;142

Forms


Lab Portfolio Lab Lead Form

Abbott POC Piccolo Xpress

HbA1c and Glucose

FROM SAMPLE TO RESULT IN 3 SIMPLE STEPS

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Step 1: Add sample

Step 2: Insert rotor

Step 3: Read results Additional POC

ONE, EASY-TO-USE PLATFORM Hepatic Function Panel

MetLyte Plus CRP BUN CK ClCRE GLU

K+ Na+ tCO2 CRP eGFR*

07P02-14

TS

IN

DBIL TBIL TP

UL

12-M

Moderately Complex Panels

ALB ALP ALT AST

UTE RES

Basic Metabolic Panel Plus K+ BUN Na+ Ca tCO2 CICRE Mg GLU eGFR* Lactate Dehydrogenase

07P02-06

07P02-13

Biochemistry Panel Plus

MetLac 12 Panel

ALB ALP ALT AMY AST BUN Ca

CRE CRP GGT GLU TP UA eGFR*

07P02-15

ALB BUN Ca ClCRE GLU

LAC K+ Mg Na+ PHOS

Urinalysis

Hematology Chemistry Immunoassay

Specialty

07P02-16

ESR Blood Gas

Coagulation Cardiac

*Calculated. Note: Each panel comes in a package of 10. 1. Crocker, J et al, Implementation of Point-of-Care Testing in an Ambulatory Practice of an Academic Medical Center, Am J Clin Pathol November 2014;142:640-646 2. Actual savings can vary depending on state-specific factors.

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Abbott POC Piccolo Xpress

HbA1c and Glucose

REAL-TIME CHEMISTRY. REAL-WORLD BENEFITS. • Optimize efficiency and productivity with fast, accurate, on-site testing • Make decisions with confidence with lab-accurate results • Maintain compliance with automated quality control features

Lipid Profile Medline POC

• Increase patient satisfaction by reducing the need for call-backs • Meet a range of testing needs with a single, versatile platform

BROAD CLINICAL APPLICATIONS.

Influenza A & B / RSV

Strep

Piccolo Xpress meets a wide range of clinical testing needs across a variety of healthcare settings and specialties. ®

• Urgent Care

• Primary/Family Care

• Pediatrics

• Internal Medicine

• Long-Term Care

• Ambulatory Surgery

• Cardiology

• Oncology

• Dermatology

• Hospital Clinics

Additional POC Urinalysis

Hematology

LAB-A WITHO

Chemistry

Immunoassay

Specialty

ESR Blood Gas

Scan this code to see the Piccolo Xpress in action.

To learn more about how the Piccolo Xpress can transform your practice, contact your Abbott Point of Care Representative, or visit www.abbottpointofcare.com

Coagulation Cardiac

For in vitro diagnostic use only © Abbott Point of Care Inc. 046406 Rev. A 07/16. Piccolo Xpress , Piccolo and iQC are registered trademarks of Abaxis, Inc. Abaxis Part Number 888-3293 Rev. A. ®

CHOOSE TRANSFORMATION™ See Inspiration in Action at abbottpointofcare.com

®

®

LIS/Resources Forms


Lab Portfolio Abbott POC i-STAT

Lab Lead Form POINT OF CARE

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology

FOR IN VITRO DIAGNOSTIC USE ONLY

Chemistry Immunoassay

i-STAT SYSTEM TEST CARTRIDGES

ASSAYS TO MEET A WIDE RANGE OF CLINICAL NEEDS

WITH LAB- QUALITY RESULTS IN MINUTES

Specialty

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Abbott POC i-STAT

HbA1c and Glucose

THE i-STAT FAMILY OF TEST CARTRIDGES

THIS TEST MENU IS INTENDED FOR USE ONLY IN THE UNITED STATES. FOR IN VITRO DIAGNOSTIC USE ONLY.

Lipid Profile

CARTRIDGES EC8+

CG8+

EG7+

CHEM8+

EG6+

G

Crea

CHEMISTRIES/ELECTROLYTES

ACTk

ACTc

PT/INR

ß-hCG

cTnI

MedlineCK-MB POC

Influenza A & B / RSV

Sodium (Na) Potassium (K) Chloride (Cl)

Strep

TCO2 Anion Gapa Ionized Calcium (iCa)

Additional POC

Glucose (Glu) Urea Nitrogen (BUN)

Urinalysis

Creatinine (Crea) HEMATOLOGY

Hematocrit (Hct)

Hematology

Hemoglobin (Hgb)a

Chemistry

BLOOD GASES

pH PCO2 PO2

Immunoassay

TCO2a HCO3a

Specialty

Base Excess (BE)a sO2a COAGULATIONb

ESR

ACT Kaolin ACT Celite®

Blood Gas

PT/INR

Coagulation

ENDOCRINOLOGYb

ß-hCG

Cardiac

CARDIAC MARKERSb

cTnl CK-MB BNP Calculated. See Intended Use information at right.

LIS/Resources

a

b

= CLIA waived: granted waived status for lithium heparin whole-blood venous samples only collected in a lithium heparin evacuated tube.

BNP

Forms


R

Lab Portfolio Lab Lead Form

Abbott POC i-STAT

HbA1c and Glucose 2-MONTH, ROOM-TEMPERATURE STORAGE

FOR COMPLETE TEST CARTRIDGE INFORMATION

Lipid Profile

AND INSTRUCTIONS FOR USE, VISIT WWW.POINTOFCARE.ABBOTT

EXPECTED VALUES && TIME TO RESULT EXPECTED VALUES TIME RESULT EXPECTED VALUES & TIME TO TO RESULT ß-hCG

cTnI

CK-MB

BNP

ANALYTE ANALYTE

Sodium (Na) Sodium (Na) Potassium (K) Potassium (K) Chloride (Cl) Chloride (Cl) TCO TCO22 Anion Gapa Anion Gapa Ionized Calcium (iCa) Ionized Calcium (iCa)

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REPORTABLE REPORTABLE RANGE RANGE

REFERENCE REFERENCE RANGE, RANGE, ARTERIAL ARTERIAL

REFERENCE REFERENCE RANGE, RANGE, VENOUS VENOUS

POC i-STATMedline TEST CARTRIDGES

APPROX. APPROX. TIME TO TIME TO RESULT RESULT

Influenza A & B / RSV EC8+, CG8+, EG7+, CHEM8+, EG6+

24-29 mmol/L 24-29 mmol/L 10-20 mmol/L 10-20 mmol/L

2 min 2 min 2 min 2 min 2 min 2 min 2 min 2 min 2 min 2 min

1.12-1.32 mmol/L 1.12-1.32 mmol/L

1.12-1.32 mmol/L 1.12-1.32 mmol/L

2 min 2 min

CG8+, EG7+, CHEM8+

70-105 mg/dL 70-105 mg/dL 8-26 mg/dL 8-26 mg/dL

2 min 2 min

EC8+, CG8+, CHEM8+, G

0.6-1.3 mg/dL 0.6-1.3 mg/dL

2 min 2 min

EC8+, CHEM8+

Creatinine (Crea) Creatinine (Crea)

3-140 mg/dL 3-140 mg/dL 0.2-20.0 mg/dL 0.2-20.0 mg/dL

70-105 mg/dL 70-105 mg/dL 8-26 mg/dL 8-26 mg/dL 0.6-1.3 mg/dL 0.6-1.3 mg/dL

2 min 2 min

CHEM8+, CREA

Hematocrit (Hct) Hematocrit (Hct)

15-75 %PCV 15-75 %PCV

38-51 %PCV 38-51 %PCV

38-51 %PCV 38-51 %PCV

2 min 2 min

EC8+, CG8+, EG7+, CHEM8+, EG6+

Hemoglobin (Hgb)a Hemoglobin (Hgb)a

5.1-25.5 g/dL 5.1-25.5 g/dL

12-17 g/dL 12-17 g/dL

12-17 g/dL 12-17 g/dL

2 min 2 min

EC8+, CG8+, EG7+, CHEM8+, EG6+

6.50-8.20 6.50-8.20

7.35-7.45 7.35-7.45

7.31-7.41 7.31-7.41

2 min 2 min

EC8+, CG8+, EG7+, EG6+

PCO PCO22

5-130 mmHg 5-130 mmHg

35-45 mmHg 35-45 mmHg

41-51 mmHg 41-51 mmHg

2 min 2 min

EC8+, CG8+, EG7+, EG6+

PO PO22

5-800 mmHg 5-800 mmHg

80-105 mmHg 80-105 mmHg

2 min 2 min

CG8+, EG7+, EG6+

TCO a TCO22a

5-50 mmol/L 5-50 mmol/L

23-27 mmol/L 23-27 mmol/L

24-29 mmol/L 24-29 mmol/L

2 min 2 min

EC8+, CG8+, EG7+, EG6+

HCO HCO

1.0-85.0 mmol/L 1.0-85.0 mmol/L

22-26 mmol/L 22-26 mmol/L

23-28 mmol/L 23-28 mmol/L

2 min 2 min

EC8+, CG8+, EG7+, EG6+

(-30)-(+30) mmol/L (-30)-(+30) mmol/L

(-2)-(+3) mmol/L (-2)-(+3) mmol/L

(-2)-(+3) mmol/L (-2)-(+3) mmol/L

EC8+, CG8+, EG7+, EG6+

0-100 % 0-100 %

95-98 % 95-98 %

2 min 2 min 2 min 2 min

CG8+, EG7+, EG6+

Glucose (Glu) Glucose (Glu) Urea Nitrogen (BUN) Urea Nitrogen (BUN)

pH pH

a 3a 3

Base Excess (BE)a Base Excess (BE)a sO sO

a 2a 2

100-180 mmol/L 100-180 mmol/L

138-146 mmol/L 138-146 mmol/L 3.5-4.9 mmol/L 3.5-4.9 mmol/L

138-146 mmol/L 138-146 mmol/L 3.5-4.9 mmol/L 3.5-4.9 mmol/L

98-109 mmol/L 98-109 mmol/L

98-109 mmol/L 98-109 mmol/L

5-50 mmol/L 5-50 mmol/L (-10)-(+99) mmol/L (-10)-(+99) mmol/L

23-27 mmol/L 23-27 mmol/L 10-20 mmol/L 10-20 mmol/L

0.25-2.50 mmol/L 0.25-2.50 mmol/L 20-700 mg/dL 20-700 mg/dL

2.0-9.0 mmol/L 2.0-9.0 mmol/L 65-140 mmol/L 65-140 mmol/L

EC8+, CG8+, EG7+, CHEM8+, EG6+

CHEM8+

Additional POC

EC8+, CHEM8+

Chemistry

Immunoassay

Specialty

50-1000 Seconds 50-1000 Seconds

74-137 Seconds (Prewrm) 74-137 Seconds (Prewrm) Max 16.7 min 74-137 Seconds (Prewrm) 74-137 Seconds (Prewrm) Max 16.7 min

ACT k

ACT Celite® ACT Celite®

50-1000 Seconds 50-1000 Seconds

74-125 Seconds (Prewrm) 74-125 Seconds (Prewrm) Max 16.7 min 74-125 Seconds (Prewrm) 74-125 Seconds (Prewrm) Max 16.7 min

ACT c

PT/INR PT/INR

0.9-8.0 INRc 0.9-8.0 INRc

ß-hCG ß-hCG

5.0-2000.0 IU/L 5.0-2000.0 IU/L

<5 IU/L <5 IU/L

10 min 10 min

Total ß-hCG

0.00-50.00 ng/mL 0.00-50.00 ng/mL

0.00-0.08 ng/mLd 0.00-0.08 ng/mLd

10 min 10 min

cTnl

CK-MB CK-MB

0.0-150.0ng/mL ng/mL 0.0-150.0

0.0-3.5ng/mL ng/mLe e 0.0-3.5

min 55min

CK-MB

BNP BNP

15-5000pg/mL pg/mL 15-5000

<15-50pg/mL pg/mLe e <15-50

10min min 10

BNP

cTnl cTnl

Performancecharacteristics characteristicshave havenot notbeen beenestablished establishedfor forINR INRvalues valuesover over6.0. 6.0. Performance Performance not been e established for INR values over 6.0. Represents thecharacteristics 0-99%range range have of results. e Represents the 0-95% range of results. Represents Representsthe the0-99% 0-99% rangeofofresults. results. Represents the 0-95% range of results. e Represents the 0-95% range of results.

Urinalysis

Hematology

ACT Kaolin ACT Kaolin

Max 16.7 min Max 16.7 min

Strep

EC8+, CHEM8+

ESR

Blood Gas

PT/INR

Coagulation Cardiac

LIS/Resources

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dd

.

Forms


Lab Portfolio Abbott POC i-STAT

Lab Lead Form HbA1c and Glucose

THE i-STAT SYSTEM:

PROVIDING DIAGNOSTIC INSIGHTS WHEN AND WHERE THEY ARE NEEDED MOST Going beyond a single test at a single moment in time, i-STAT System with-patient testing facilitates real-time decisions in diverse settings to optimize patient care. TESTING WITH THE i-STAT SYSTEM CAN: • Standardize and consolidate testing across clinical settings • Enable rapid decision-making directly in the patient care pathway • Streamline workflow and optimize resource utilization • Expand access to testing and enhance the care-delivery experience

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

STREAMLINE PROCESSES, INCREASE EFFICIENCY, AND PROMOTE PATIENT-CENTRIC CARE.

TO LEARN MORE ABOUT THE i-STAT SYSTEM, CONTACT YOUR ABBOTT POINT OF CARE REPRESENTATIVE OR VISIT WWW.POINTOFCARE.ABBOTT

INTENDED USE ACT Kaolin - The i-STAT Kaolin Activated Clotting Time (KaolinACT) test is an in vitro diagnostic test that uses fresh, whole blood, and is used to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery. ACT Celite® - The i-STAT Celite Activated Clotting Time (CeliteACT) test is an in vitro diagnostic test that uses fresh, whole blood, and is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures, such as catheterization, cardiac surgery, surgery, organ transplant, and dialysis. PT/INR - The i-STAT PT, a prothrombin time test, is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin® or warfarin

Hematology Chemistry Immunoassay

Specialty

ß-hCG -The i-STAT Total Beta-Human Chorionic Gonadotropin (ß-hCG) test is an in vitro diagnostic test for the quantitative and qualitative determination of ß-hCG in venous whole blood or plasma samples using the i-STAT 1 Analyzer Systems. The test is intended to be used as an aid in the early detection of pregnancy and is for prescription use only.

ESR

cTnI- The i-STAT cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

Blood Gas

CK-MB -The i-STAT CK-MB test is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI). BNP -The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-type natriuretic peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.

Coagulation Cardiac

FOR IN VITRO DIAGNOSTIC USE ONLY. THIS BROCHURE IS INTENDED ONLY FOR A U.S. AUDIENCE.

LIS/Resources

© Abbott Point of Care Inc. • 400 College Road East, Princeton, NJ 08540 USA • www.pointofcare.abbott i-STAT is a trademark of the Abbott • US Cartridge Menu Brochure 1951.3 02/20

Forms


Lab Portfolio Lab Lead Form

Abbott POC i-STAT

HbA1c and Glucose

PERFORM A WIDE RANGE OF TESTS IN JUST A FEW MINUTES. CLIA-WAIVED PANELS CHEMISTRY

Lipid Profile

®

Medline POC

RESULTS TYPICALLY IN 2 MINUTES

Abbott Part No.

CHEM8+

Na, K, Cl, iCa, TCO2†, Glu, BUN/Urea, Crea, Agap†, Hct, Hgb†

CW*

09P31-25

Crea

Crea

CW

03P84-25

G

Glu

CW

03P83-25

ELECTROLYTES, HEMATOLOGY

Influenza A & B / RSV

Strep

RESULTS TYPICALLY IN 2 MINUTES

E3+

Na, K, Hct, Hgb†

CW

03P82-25

EC4+

Na, K, Glu, Hct, Hgb†

CW

03P81-25

6+

Na, K, Cl, BUN/Urea, Glu, Hct, Hgb†

CW

03P80-25

Additional POC Urinalysis

MODERATELY COMPLEX PANELS

Hematology

CARDIAC MARKERS

Abbott Part No.

cTnl

Troponin I

Results in 10 minutes

MC**

06P23-25

BNP

BNP

Results in 10 minutes

MC

03P93-25

CK-MB

CK-MB

Results in 5 minutes

MC

03P92-25

BLOOD GAS

Immunoassay

RESULTS TYPICALLY IN 2 MINUTES

G3+

pH, PCO2, PO2, TCO2†, HCO3†, BEecf†, sO2

MC

03P78-50

CG4+

pH, PCO2, PO2, TCO2†, HCO3†, BEecf†, sO2†, Lactate

MC

03P85-50

BLOOD GAS, ELECTROLYTES, HEMATOLOGY

Chemistry

RESULTS TYPICALLY IN 2 MINUTES

CG8+

Na, K, iCa, Glu, pH, PCO2, PO2, TCO2†, HCO3†, BEecf†, sO2†, Hct, Hgb†

MC

03P88-25

EG7+

Na, K, iCa, pH, PCO2, PO2, TCO2†, HCO3†, BEecf†, sO2†, Hct, Hgb†

MC

03P76-25

EC8+

Na, K, Cl, pH, PCO2, BUN/Urea, Glu, TCO2†, HCO3†, BEecf†, Agap†, Hct, Hgb†

MC

03P79-25

EG6+

Na, K, pH, PCO2, PO2, TCO2†, HCO3†, BEecf†, sO2†, Agap†, Hct, Hgb†

MC

03P77-25

Prothrombin Time Results in ≤5 minutes

MC

03P89-24

ACT

Celite ACT

Results in <17 minutes

MC

03P86-25

ACT

Kaolin ACT

Results in <17 minutes

MC

03P87-25

ß-hCG

Results in 10 minutes

MC

05P58-25

Specialty

ESR Blood Gas

COAGULATION PT/INR Celite

Kaolin

PREGNANCY Total ß-hCG

Coagulation Cardiac

LIS/Resources *CW = CLIA-WAIVED PANEL **MC = MODERATELY COMPLEX PANEL † Calculated See CTI sheets for full details at abbottpointofcare.com

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®

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SIMPLE AND COMPLETE The i-STAT System Distribution Kit comes complete with downloader/recharger, printer, and electronic simulator. (Waived Kit Part No. 04J60-20, Moderately Complex Kit Part No. 04J48-50)

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To learn how the i-STAT System can transform your patient care, contact your Abbott Point of Care Representative, or visit www.abbottpointofcare.com

Hematology Chemistry

INTENDED USE Lactate The test for lactate, as part of the i-STAT System, is intended for use in

the in vitro quantification of lactate in arterial, venous, or capillary whole blood. The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.

cTnl The i-STAT Cardiac Troponin l (cTnl) test is an in vitro diagnostic test for the

quantitative measurement of cardiac troponin l (cTnl) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

CK-MB The i-STAT CK-MB test is an in vitro diagnostic test for the quantita-

tive measurement of creatine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).

BNP The i-STAT BNP test is an in vitro diagnostic test for the quantitative mea-

surement of B-type natriuretic peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.

ACT Kaolin The i-STAT Kaolin Activated Clotting Time (KaolinACT) test is an in vitro diagnostic test that uses fresh, whole blood, and is used to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery. ACT Celite® The i-STAT Celite Activated Clotting Time (CeliteACT) test is an in vitro diagnostic test that uses fresh, whole blood, and is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery, organ transplant, and dialysis.

PT/INR The i-STAT PT, a prothrombin time test, is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin® or warfarin.

ß-hCG The i-STAT Total Beta-Human Chorionic Gonadotropin (ß-hCG) test is an in vitro diagnostic test for the quantitative and qualitative determination of ß-hCG in venous whole blood or plasma samples using the i-STAT 1 Analyzer Systems. The test is intended to be used as an aid in the early detection of pregnancy and is for prescription use only. For full details, see CTI sheets at abbottpointofcare.com

Immunoassay

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Coagulation

Abbott Point of Care Inc. 400 College Road East, Princeton, NJ 08540 (609) 454-9000 (609) 419-9370 (fax) For in vitro diagnostic use only. © Abbott Point of Care Inc. i-STAT and CHOOSE TRANSFORMATION are registered trademarks of the Abbott Group of companies in various jurisdictions. 047010 Rev. B 10/17

Cardiac

CHOOSE TRANSFORMATION See Inspiration in Action at abbottpointofcare.com

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Alfa Wassermann ACE Axcel

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Welcome to the

SMART LAB Reliable. Accurate. Results.

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ACE Axcel® Clinical Chemistry System

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Alfa Wassermann ACE Axcel

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Reliable. Accurate. Results.

Intelligence for the Physician Office Lab

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From the market leader in POL chemistry testing ACE Axcel from Alfa Wassermann is a next-generation

clinical chemistry system that sets the standard for excellence in today’s Physician Office Laboratory (POL). With touch screen functionality, an intuitive user interface, and Internet connectivity, the ACE Axcel offers the latest advances to make in-office laboratory testing fast, convenient, and cost-effective.

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The ACE Axcel’s comprehensive menu of routine and specialized assays provides an effective tool in the diagnosis and management of diabetes, heart disease, metabolic syndrome, and anemia, as well as other diseases.

Urinalysis

Hematology

Designed to meet the needs of the POL, it has been cleared by the US Food and Drug Administration specifically for use in Physician Office Labs. ACE Axcel. It’s one of the smartest additions to your lab.

Chemistry Monitor Reagent Volume

Immunoassay

Reliable in-office laboratory testing with the ACE Axcel allows the physician to diagnose, monitor, and treat patients faster.

Provide your Better for Patients patients with • Fast – Process up to 285 tests per accurate, timely hour with both photometric and potentiometric detection technologies. results. With the ACE Axcel, you • Reliable Results – Avoid sample loss or deterioration caused by transportation get quality results to an off-site lab. covering a range of the most widely • Convenient – Patients don’t have to travel to off-site labs for testing. On-site tested conditions, testing facilitates patient compliance, plus convenience reduces callbacks, and aids prescription for your patients. management.

Better for Business

Better for Lab Personnel

• Keep laboratory revenues in-house.

• Intuitive software and comprehensive

• Perform single or panel tests from extensive test menu. Open reagent system enables custom assays. • Increase regulatory compliance with easy-to-operate system. • Seamlessly connect with Electronic Health Records via Lab Information Systems (LIS).

Specialty

Th us th ta wh

ESR

Sa

user training.

• Maximum instrument uptime with Alfa AssistTM, offering web-enabled technical support 24/7. • Increased confidence in test results. Join one of the largest peer groups in POLs, making it easy to compare QC results with other Alfa Wassermann users. • Award-winning service – Alfa Wassermann, a proven provider of excellent customer satisfaction.

To

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Clo ST int fo sa co


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Check Reagent Status

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Smart Tool. Smart Lab. Run your Physician Office Lab more efficiently, more economically – and more intelligently – with the ACE Axcel. The third generation of the ACE chemistry system improves both patient care and your bottom line.

Smart Features • Touch screen technology for instinctive control

Strep

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• Easy-to-use graphical user interface • Internet connectivity allows for technical support, remote access, and laboratory integration • Optional barcode scanner automates sample identification and streamlines workflow

More Intelligence • Run panels, profiles, or single tests, in any combination at any time

Monitor Reagent Volume

Hematology Chemistry Chemistry

• Create custom panels to meet the needs of your practice • STAT interrupt allows users to load and prioritize STAT samples during operation for immediate diagnosis and treatment

Touch Screen Technology The touch screen monitor allows users to quickly and easily navigate the ACE Axcel. Instrument operation takes just the touch of a finger, even while wearing gloves.

Safety with STEP Closed-tube sampling with the STEP module minimizes operator interaction with the sample, making for a safer workplace. Patient samples remain sealed in blood collection tubes.

• Auto Rerun and Dilution ensures fast, accurate reporting of abnormal test results without operator intervention

Immunoassay

• System calibration automatically monitored; 30-day calibration interval for most assays • Seamless integration with Electronic Health Records via Laboratory Information Systems

Greater Productivity • On-board reagent refrigeration maintains specimen and reagent integrity; reduces specimen and reagent handling

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ESR

• Liquid, ready-to-use reagents eliminate prep time, improving operator productivity • Automatic reagent inventory management • Self-contained system in a small footprint; ACE Axcel needs no dedicated waste disposal or water system

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Alfa Wassermann ACE Axcel

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Over A Decade of Award-Winning Customer Service

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Additional POC For over a decade, Alfa Wassermann has received the NorthFace ScoreboardSM Award for Excellence in Customer Satisfaction. An objective benchmark for service and support, the NorthFace Award represents the true voice of the customer.

Urinalysis

Hematology Alfa Wassermann is the market leader in clinical chemistry systems for the Physician Office Laboratory. We take pride in providing the highest level of customer service. We listen. We care. And it shows. Your Alfa Wassermann team includes a nationwide network of company-trained engineers and support personnel who provide 24/7 technical support. We bring more than 35 years of manufacturing and service excellence to build and support market-leading clinical chemistry systems. Now, through Alfa Assist™, we enhance your user experience. Web-enabled, remote access facilitates proactive, consultative support and educational services.

Alfa Wassermann analyzers help you: • Screen for diseases • Diagnose and treat sooner • Monitor progress and adjust treatments as necessary

Chemistry

In today’s competitive environment, we recognize that operating a successful and cost-effective practice requires diagnostic testing that is smart, fast, reliable, and accurate. ACE Axcel is the intelligent choice for your smart lab.

Immunoassay

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For more information or to schedule a demo, please call 1-800-220-4488 or visit www.AlfaWassermannUS.com. Alfa Wassermann Diagnostic Technologies

4 Henderson Drive West Caldwell, NJ 07006 Tel: 1-800-220-4488 www.AlfaWassermannUS.com info@alfawassermannus.com

ESR Blood Gas

SM462 Rev 3 10/15

Coagulation Cardiac

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Magenta Rule does not print. JUst indicates the trim. Final Flat size should be 28" wide

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ACE Axcel® Clinical Chemistry System

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Cardiovascular Risk Assessment

Cholesterol High Density Lipoprotein Cholesterol

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Low Density Lipoprotein Cholesterol Triglycerides

Diabetes

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Glucose Hemoglobin A1c

Anemia Assessment Ferritin Iron

Enzyme Assays

Alanine Aminotransferase Alkaline Phosphatase Amylase Aspartate Aminotransferase

Routine Chemistry Assays Albumin Bilirubin, Direct Bilirubin, Total Blood Urea Nitrogen Calcium Carbon Dioxide

Electrolyte Assays Chloride Potassium

Strep

Urinalysis

TIBC, Direct Hematology

Creatine Kinase Gamma-Glutamyl Transferase Lactate Dehydrogenase Lipase Creatinine Inorganic Phosphorous Magnesium Total Protein Uric Acid

Chemistry Immunoassay

Specialty

ESR Blood Gas

Sodium

Coagulation

Thyroid Assays

Cardiac

Total Thyroxine (T4)

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Alfa Wassermann Diagnostic Technologies 4 Henderson Drive

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Reliable. Accurate. Results.

Reliable. Accurate. Alfa Wassermann.

ACE Axcel® Clinical Chemistry System Technical Specifications

Operative Method: Random access, Continuous Random Access Type: Discrete Assay Method: Photometry, Potentiometry, Turbidimetric/Homogeneous EIA Assay Types: Final Point, Delta (two-point), Slope (factor or calibrated), Quadratic ISE Module: Sodium, Potassium, Chloride Test Modes: Batch, STAT Number of Different Assays Measured Onboard Simultaneously: 40 Speed: Up to 165 Photometric Tests/Hour; 285/hour (with ISE) Sample Rerun and Dilution: Automatic Calibration and Controls: Automatic Reagent Compartment Capacity: 40 Bottles (20 with 30 mL capacity; 20 with 12 mL capacity) Barcode Type: Uniform Symbology Specification 39, Code 128 Set B and Set C, Codabar and Interleaved 2 of 5 Sample Volume: 3 μL (minimum) - 500 μL (maximum) Dimensions: 33'' x 28'' x 26'' (height x length x depth) Weight: 178 Pounds

Computer Processor: Panel PC with Intel J1900 CPU, 2 GB memory Solid State Disk Drive: 32 GB Monitor: 15" XGA with Resistive Touch Screen Operating System: Windows 7 Embedded Interface: RS232 Internet Connection: RJ-45 Gigabit Ethernet; 802-11 b/g Wireless Printer: Black and White Laser Printer Keyboard Type: 103 Key Error Messages: On Screen Type: Holographic Diffraction Grating with Diode Array Detector Linear Range: 0.0000–2.0000 O.D. at 0.67 cm Pathlength Lamp: Pulsed Xenon Wavelengths: 340, 378, 408, 447, 486, 505, 515, 525, 544, 554, 573, 592, 610, 629, 647, 692 nm Pathlength: 0.67 cm Noise (decibels): 55 Ambient Room Temperature: 15 °C (59 °F) to 26.7 °C (80 °F) Humidity: 20 to 80% RH (non-condensing) Analytical Temperature: 37 °C ± 0.3 °C Reagent Compartment Temperature: 8 °C ± 1 °C at the Reagent Sensor Voltage: 100-240 VAC 6 Amps Max – Analyzer; 120 VAC 8 Amps Max – Printer Current: 20 Amp Circuit Required Frequency: 47-63 Hz

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Lab Portfolio Siemens Dimension EXL Family + Test Menu

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Chemistry

Meet expanding needs with a proven, integrated system. The Dimension EXL family of systems offers you a choice of solutions with our patented LOCI technology inside.

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www.siemens.com/diagnostics

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Answers for life.

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Versatile, Fast, Accurate, and Easy-to-use—the Dimension EXL Family of Integrated Systems Dimension EXL Integrated Chemistry Systems can be found in laboratories running 50,000 tests per year and supporting highvolume Siemens automation solutions in laboratories running millions more.

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2

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Siemens Dimension EXL Family + Test Menu

Dimension EXL with LM Integrated Chemistry System

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Dimension EXL 200 Integrated Chemistry System

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The Multifaceted Dimension EXL Family of Integrated Systems

Hematology

Siemens Healthcare Diagnostics was the first to integrate chemistry and immunoassay testing on a single platform, and has increased immunoassay efficiency on the Dimension® EXL™ family of systems with our patented LOCI® advanced chemiluminescent technology. This technology processes immunoassay tests more quickly, while increasing the reliability and sensitivity of test results.

The Dimension EXL family of integrated systems reduces process pre-analytics associated with splitting sample tubes in order to run samples concurrently on dedicated stand-alone chemistry and immunoassay systems. Dimension EXL systems also feature a comprehensive menu that covers the majority of critical laboratory assays and simultaneous processing capabilities with:

“The Dimension EXL system with the LOCI module helps us contribute to better patient care because it’s faster and it’s more accurate,” says Donna Hartsell, Section Head of Chemistry at Caldwell Memorial Hospital in Lenoir, North Carolina. “I feel very confident about the results that we send out. I trust the instrument explicitly.”

• One sample area

The Dimension EXL family of systems can be found in thousands of low-volume, mid-volume and STAT laboratories worldwide. Dimension EXL systems are also used in satellite laboratories partnered with a Siemens automation solution in the core laboratory.

Chemistry Immunoassay

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• A common reagent area • Common reagent packaging “The Dimension EXL system performed great,” says Tim Schroeder, Laboratory Manager at Marengo Memorial Hospital in Marengo, Iowa. “This is a 21st century instrument that will allow us to expand our test menu and outreach services.”

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Implement LOCI Technology— Only from Siemens

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and rapid results required for timely diagnosis of acute myocardial infarction (AMI). It allows for early detection by meeting the guidelines criterion of ≤10% CV at the 99th percentile population, supports the rapid triage of chest-pain patients, and improves acute-care workflow between serial measurements (6h reduced to 3h protocols) with an 11-minute time to first result, utilizing either a plasma or a serum sample.

LOCI® advanced chemiluminescent technology, featured on the Dimension EXL family of systems, combines small sample sizes, high-performance assays, and just three processing steps to quickly deliver patient results. • Improved Assay Performance LOCI advanced chemiluminescent technology is the first and only homogeneous chemiluminescent immunoassay technology with direct measurement available on a commercial automated system. This patented technology provides rapid turnaround times (TATs) with excellent reliability and reproducibility.

TNI Functional Sensitivity

• Reliable Results with Low-sample Volumes LOCI methods use low sample volumes (all analyte tests can be performed with just 8 to 20 μL of sample) because of the sensitivity of the technology and elimination of washing/ separation steps. Low sample volumes reduce the risk of nonspecific binding (NSB). This, along with method-specific NSB-suppressing agents, increases the reliability of LOCI test results.

Strep

Urinalysis Hematology

Chemistry

Troponin ng/mL (µg/L) The Joint European Society of Cardiology/American College of Cardiology Committee recommends an imprecision level (coefficient of variation, CV) for troponin assays of ≤10% at the 99th percentile of normal.

• Rapid TAT with LOCI Cardiac Troponin I (TNI) Assay The TNI assay on the Dimension EXL family of integrated systems meets the standard of performance for accurate

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ESR

How LOCI chemiluminescent technology works:

Blood Gas

Analyte

Chemibead

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% Total CV

• Reduced Process Steps The unique oxygen channeling technology of LOCI streamlines the process of running an assay into three simple steps: mix, incubate, and read. This eliminates extra steps of separating, washing, and adding amplification reagents that are necessary with standard heterogeneous immunoassays.

Medline POC

Light Stimulation

Chemiluminescence Light Stimulation

Biotinylated Receptor

Coagulation

Robe Profe

Bead Immunocomplex Sensibead

o2 Production

1

LOCI technology uses two dye-containing latex beads (a streptavidin-coated Sensibead and a method-specific Chemibead) and a biotinylated analyte-specific receptor. The basic assay steps combine the three reactants with analyte to form an immunocomplex. Illumination of the complex (680 nm) releases singlet oxygen from the Sensibeads, which channels into the Chemibeads and triggers chemiluminescence that can be measured at 612 nm, a very low threshold.

“ Th br se sp wh re ha

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“ The advent of LOCI technology has enabled a breakthrough in the measurable levels of functional sensitivity and precision of various assays, specifically the cardiac tests such as troponin I, where sensitivity at the 99th percentile of the reference control population is crucial. Siemens has hit a home run with these assays.”

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Robert H. Christenson, PhD, DABCC, FACB Professor of Pathology, University of Maryland School of Medicine

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Siemens Dimension EXL Family + Test Menu

Deliver Fully Integrated Chemistry and Immunoassay Testing from Your Laboratory Which Dimension EXL system is right for your laboratory? Siemens has the right solution for your laboratory. With the Dimension EXL family of systems, you can increase your efficiency and productivity while taking advantage of the latest technology in an integrated system. Both the Dimension EXL with LM Integrated Chemistry System and the Dimension EXL 200 Integrated Chemistry System offer:

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• Continuous loading – No need to pause the systems to load samples, reagents or consumables

Di Im

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Siem expe a day

• Ready-to-use operation – No reagent preparation with Flex® cartridges – No manual pretreatment of whole-blood samples – No cuvette carryover with disposable reaction cuvettes • Workflow excellence – Validated calibration of up to 90 days – Automated onboard calibration for IMT – Low daily, weekly, and monthly maintenance

Completing the integration of technologies on the Dimension EXL Integrated Chemistry Systems are:

• Universal STAT positions Throughput Samples per hour (up to)

200*

Photometric tests per hour (up to)

440

IMT tests per hour (up to)

187

• QuikLYTE IMT for Na, K, and Cl results in 58 seconds

HM tests per hour (up to)

167

• Flexible photometry: routine and specialty chemistry tests, therapeutic drug monitoring, and drugs-of-abuse and toxicology testing with Syva® Emit® reagents

Hematology

Chemistry Immunoassay

• Heterogeneous immunoassay menu, including immunosuppressive, oncology, and reproductive endocrinology ®

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*On the VersaCell X3 Solution/Dimension Suite.

Specialty

ESR Blood Gas Coagulation

Choose the right system for your laboratory based on reagent capacity and footprint

Cardiac Dimension EXL with LM System

Dimension EXL 200 System

Reagent capacity

88 Flex + 3 IMT = 91

44 Flex + 3 IMT = 47

Footprint

2.2 sq m (23.3 sq ft)

1.5 sq m (16.2 sq ft)

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Wo Tru

Work adm inno enha patie diag offer staff will g or in You offer

“Serv has with does

Siem Siem servi acce thro and remo


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Discover How High-level Productivity Can Improve Your Laboratory Today

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Strep Siemens provides customers with the technical Dimension Suite provides one-touch sample management and STAT prioritization for an expertise and guidance they need 24 hours extensive mix of analytics. a day, 7 days a week.

CentraLink Data Management System delivers quality laboratory results faster for better patient care.

Work with Siemens as Your Trusted Partner

VersaCell X3 Solution/Dimension Suite and IT Solutions Available from Siemens

Working closely with laboratorians, clinicians, and hospital administrators, Siemens Healthcare Diagnostics creates innovative solutions that transform diagnostics by enhancing operational efficiencies and helping to improve patient care. Committed to being your single source for diagnostic instruments, service, and support, Siemens offers a Personalized Education Program (PEP) to help your staff maximize their productivity. Siemens representatives will give your laboratory dedicated technical support online or in person, wherever and whenever service is needed. You can be confident in the workflow resources Siemens offers to enhance the operations of your laboratory.

The VersaCell® X3 Solution/Dimension Suite delivers extensive menu coverage, excellent STAT priority management, and automation benefits that improve workflow to sustain a high level of productivity in the mid-volume laboratory.

“Service and support from Siemens is excellent. It always has been,” says Hartsell. “The call center gets back to us within 30 minutes and 9 out of 10 times, the service rep does too.” Siemens Remote Service for Diagnostics (SRS), part of the Siemens Customer Care program, is a real-time remote service that connects your instruments with continuous access to global technical support from Siemens. Delivered through a secure network, SRS increases system uptime and efficiency by identifying issues early, resolving them remotely, and expediting on-site repair if required.

CentraLink™ Data Management System, an integral part of Siemens’ proven laboratory solutions, empowers labs to efficiently deliver timely, accurate results by customizing and streamlining workflows across automation, analyzers, and IT.

Let's get started! Select from the Dimension EXL family of systems for the next level of proven chemistry and immunoassay integration on a single platform. Get rapid, accurate immunoassay results with the sensitivity and speed of LOCI technology.

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Visit www.siemens.com/diagnostics to learn more about the Dimension EXL systems and LOCI advanced chemiluminescent technology.

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Chemistry CentraLink, Dimension, Emit, EXL, FLEX, LOCI, QuikLYTE, Syva, VersaCell, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. or its affiliates. All other trademarks and brands are the property of their respective owners.

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Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

ESR

Order No. A91DX-CAI-140978-GC1-4A00 06-2015 | All rights reserved © 2015 Siemens Healthcare Diagnostics Inc.

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M p

Th wit

ww Global Siemens Headquarters Siemens AG Wittelsbacherplatz 2 80333 Muenchen Germany

Global Siemens Healthcare Headquarters Siemens AG, Healthcare Henkestrasse 127 91052 Erlangen Germany Telephone: +49 9131 84-0 www.siemens.com/healthcare

Global Division Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591-5005 USA www.siemens.com/diagnostics

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Atellica Solution + Test Menu

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Take control. Simplify lab operations.

Drive better outcomes.

The Atellica® Solution: flexible, scalable, automation-ready immunoassay and chemistry analyzers

siemens.com/atellicasolution

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Atellica Solution + Test Menu

Transform care delivery with the power of the Atellica Solution

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The Atellica Solution i

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and simplicity, so you

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Gain independent control ove every sample.

Strep

The multicamera vision system intelligent scheduling software characterizes, routes, and contro every sample, routine and STAT. Atellica® Sample Handler with t Additional POC Atellica Magline® Transport:

• Accommodates more than 30 s container types, including pedi and special containers.

•Urinalysis Automatically scans each sam and dynamically adjusts to op individual sample managemen

• Delivers bi-directional, variable

magnetic sample transport 10 Hematology than conventional sample con

Rapid growth in test volumes. Testing consolidation. STAT prioritization. In today’s healthcare environment, laboratories are seeking to transform care delivery through streamlined operations and increased workforce productivity. They require effective ways to maximize service quality, improve cost-efficiency, and drive better outcomes for clinicians and patients.

The Atellica® Solution is a breakthrough answer to your pressing lab challenges. Its revolutionary advances set a new standard in sample management, giving you independent control over every sample. With industry-leading productivity, unprecedented flexibility, and highly specific and sensitive assays, the Atellica Solution empowers your lab to deliver accurate, timely results.

• Minimizes operator interventio with automatic QC and calibra scheduling and delivery.

Chemistry

To learn more about th representative today. *Dependent upon test mix. Immunoassay

†Service availability varies by country.

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Atellica Solution + Test Menu

HbA1c and Glucose The Atellica Solution introduces a game-changing generation of flexible, scalable, automation-ready immunoassay and chemistry analyzers engineered to deliver control and simplicity, so you can drive better outcomes.

Gain independent control over every sample.

Streamline operations and future proof your lab.

The multicamera vision system with intelligent scheduling software characterizes, routes, and controls every sample, routine and STAT. Atellica® Sample Handler with the Atellica Magline® Transport:

Gain unprecedented flexibility so your lab can adapt easily to changing testing needs and space requirements.

• Accommodates more than 30 sample container types, including pediatric and special containers.

• Run the Atellica Solution as a standalone system or connected to Aptio® Automation for a multidisciplinary solution that increases workflow efficiency across your entire lab.

• Automatically scans each sample and dynamically adjusts to optimize individual sample management. • Delivers bi-directional, variable-speed magnetic sample transport 10 times faster than conventional sample conveyors. • Minimizes operator intervention with automatic QC and calibration scheduling and delivery.

• Combine up to 10 components in more than 300 customizable configurations including linear, L, and U shapes.

• Use the same reagents and consumables across configurations and locations for consistent patient results and streamlined inventory.

Achieve better outcomes. Deliver reliable results for your patients, your clinicians, and your lab. • Increase lab productivity. Run up to 440 tests per hour with the industry’s highest immunoassay testing productivity per square meter.* • Provide fast, predictable turnaround time and free your workforce for highvalue tasks. • Drive accurate diagnostics. A broad and expanding menu features proven detection technologies, and highly specific and sensitive assays. • Redefine serviceability. Maintain peak performance in real time with intelligent, predictive, and proactive remote services† focused on reliability.

To learn more about the Atellica Solution, please contact your local Siemens Healthineers representative today. *Dependent upon test mix. †Service availability varies by country.

Atellica Portfolio of Laboratory Products

Lipid Profile

Engineered by Siemens Healthineers to deliver control and simplicity so you can drive better outcomes.

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Tighter control of your lab, simplified workflow, and more time to focus on driving better business and clinical outcomes— that’s the promise of our Atellica® portfolio of laboratory products.

Control. Simplicity. Better Outcomes.

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Atellica Solution + Test Menu

HbA1c and Glucose At Siemens Healthineers, we enable healthcare providers to achieve better outcomes at lower costs by expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare.

Aptio, Atellica, Atellica Magline, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. or its affiliates. All other trademarks and brands are the property of their respective owners.

Healthcare providers around the world have long relied upon our engineering excellence: leading-edge, high-quality medical technologies across a broad portfolio. Our technologies help improve patient care around the world every day. At the same time, our solutions help medical institutions to continuously improve their clinical, operational, and financial outcomes.

Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

We now consolidate this unprecedented volume of data and insights and turn them into pioneering enterprise and digital health services. With those, we maximize opportunities for and share the risks of your entire health system. Partnerships are built on people. With Siemens Healthineers, there is no team more committed and connected to working with you to realize success.

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Take

Hematology Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Phone: +49 9131 84 0 siemens.com/healthineers

Local Contact Information Siemens Healthcare Diagnostics Inc. Laboratory Diagnostics 511 Benedict Avenue Tarrytown, NY 10591-5005 USA Phone: +1 914-631-8000

Published by Siemens Healthcare Diagnostics Inc. · Order No. 30-17-10699-01-76 · 02-2018 · © Siemens Healthcare Diagnostics Inc., 2018

Chemistry Immunoassay

siemens.com/atellicasolution

Specialty

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Lab Portfolio Lab Lead Form

Atellica Solution + Test Menu

HbA1c and Glucose

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Atellica Solution

For use in the U.S.

Test Menu

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Flexible, scalable, automation-ready immunoassay and clinical chemistry analyzers engineered to deliver control and simplicity so you can drive better outcomes

Urinalysis

Experience the power of the Atellica® Solution, featuring patented bidirectional magnetic sample transport technology, the flexibility to create over 300 customizable configurations, and a broad assay menu with proven detection technologies.

Hematology

General Chemistry

Chemistry Diabetes Fructosamine Hemoglobin A1c Drugs of Abuse/Toxicology 6-Acetylmorphine (6-AM)* Acetaminophen Amphetamines Barbiturates, Urine Barbiturates, Serum* Benzodiazepines, Urine Benzodiazepines, Serum* Buprenorphine* Cannabinoids (THC) Cocaine Metabolite Ecstasy Ethyl Alcohol LSD*† Methadone Methadone Metabolite (EDDP) Methaqualone*† Opiates Oxycodone† Phencyclidine Propoxyphene Salicylate Tricyclic Antidepressants*

Alanine Aminotransferase (ALT) Alanine Aminotransferase (Liquid P5P) Albumin (BCG) Albumin (BCP) Alkaline Phosphatase Ammonia Amylase Aspartate Aminotransferase (AST) Aspartate Aminotransferase (Liquid P5P) Bilirubin, Direct Bilirubin, Total Calcium (CPC) Calcium (Arsenazo)† Carbon Dioxide Chloride Cholesterol Cholinesterase Creatine Kinase Creatinine Creatinine, Enzymatic Gamma-Glutamyl Transferase (GGT) Glucose, Hexokinase Glucose, Oxidase HDL Cholesterol Iron Lactate Lactate Dehydrogenase (L-P)

*Alliance application. †Under development. Not commercially available. Future availability cannot be guaranteed.

siemens-healthineers.us/atellicasolution

LDL Cholesterol Lipase Magnesium Microalbumin Pancreatic Amylase Phosphorus Potassium Sodium Total Iron Binding Capacity (TIBC) Total Protein Total Protein, Urine Triglycerides Urea Nitrogen (BUN) Uric Acid

Immunoglobulin M (IgM) Lipoprotein(a) Prealbumin Rheumatoid Factor (RF) Soluble Transferrin Receptor (sTfR)*† Transferrin

Specific Proteins

Amikacin*† Caffeine* Carbamazepine Digoxin Gentamicin Lidocaine (LIDO)† Lithium Methotrexate* N-acetylprocainamide (NAPA)† Phenobarbital Phenytoin Procainamide (PROC)† Tacrolimus† Theophylline Tobramycin Valproic Acid Vancomycin

α1-Acid Glycoprotein (AAG) α1-Antitrypsin (AAT) Antistreptolysin O (ASO) Apolipoprotein A-1 Apolipoprotein B β-2 Microglobulin Complement C3 Complement C4 CRP CRP, High Sensitivity CRP, Wide Range† Cystatin C† FLC kappa*† FLC lambda*† Haptoglobin Immunoglobulin A (IgA) Immunoglobulin G (IgG)

Chemistry Immunoassay

Specimen Validity Testing Creatinine*† Nitrite*† Oxidant*† pH*† Specific Gravity*† Therapeutic Drug Monitoring

Specialty

ESR Blood Gas Coagulation

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Lab Portfolio Lab Lead Form

Atellica Solution + Test Menu

Atellica Portfolio of Laboratory Products Engineered by Siemens Healthineers to deliver control and simplicity so you can drive better outcomes. Tighter control of your lab, simplified workflow, and more time to focus on driving better business and clinical outcomes—that’s the promise of our Atellica® portfolio of laboratory products.

Control. Simplicity. Better Outcomes.

Atellica Solution Test Menu Immunoassay Anemia Active-B12† EPO† Ferritin Folate RBC Folate Vitamin B12 Autoimmune Anti-CCP† Bone Metabolism Intact PTH Vitamin D Total BNP CKMB High-Sensitivity Troponin I (TNIH) Myoglobin NT-proBNP§ TnI-Ultra™

Metabolic

Special ID

Growth Hormone (hGH)† IGFBP-3† IGF-I†

ACTH† Cortisol Homocysteine

Hepatitis

Oncology

EBV-EBNA IgG† EBV-VCA IgG† EBV-VCA IgM† Syphilis

Anti-HBe† Anti-HBs 2‡ HAV IgM HAV Total HBc IgM‡ HBc Total‡ HBeAg‡ HBsAg II‡ HBsAg Confirmatory‡ HCV‡**

AFP‡ BR 27.29 CA 125II CA 15-3 CA 19-9 Calcitonin† CEA Complexed PSA‡ Free PSA† PSA‡ Serum HER-2/neu

HIV HIV 1/O/2 Enhanced (EHIV) ** HIV Ag/Ab Combo (CHIV)‡**

Diabetes C-Peptide Insulin

Immunosupressant Drugs Cyclosporine Everolimus† Sirolimus† Inflammation IgE, Total IL-6† LBP†

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Growth

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Therapeutic Drug Monitoring Digitoxin Digoxin

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Thyroid

Reproductive Endocrinology Androstenedione† Anti-Mullerian Hormone (AMH)† DHEAS Enhanced Estradiol FSH hCG LH PlGF† Progesterone Prolactin sFLT-1† SHBG Testosterone II

Anti-TG Anti-TPO Free T3 Free T4 Thyroglobulin (Tg)† Total T3 Total T4 TSH3-Ultra T Uptake ToRCH CMV IgG† CMV IgM† Herpes 1† Herpes 2† Rubella IgG Rubella IgM Toxoplasma IgG Toxoplasma IgM

Urinalysis Hematology

Chemistry Immunoassay

Specialty

Sepsis †Under development. Not commercially available. Procalcitonin (PCT) Future availability cannot be guaranteed. ‡Under FDA review. §Not available for sale in the U.S. Future availability cannot be guaranteed. **Assay developed, manufactured, and sold by Siemens Healthcare Diagnostics Inc. for Ortho Clinical Diagnostics, Inc. and Grifols Diagnostic Solutions Inc.

Atellica, TnI-Ultra, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84-0 siemens-healthineers.com

For use in the U.S.

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Published by Siemens Healthcare Diagnostics Inc. Laboratory Diagnostics 511 Benedict Avenue Tarrytown, NY 10591-5005 USA Phone: +1 914-631-8000

Published by Siemens Healthcare Diagnostics Inc. · Order No. 30-18-12420-01-76 · 07-2018 · © Siemens Healthcare Diagnostics Inc., 2018

Coagulation

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Lab Portfolio Beckman Coulter AU Chemistry Analyzers

Lab Lead Form HbA1c and Glucose

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Hematology Chemistry Chemistry Immunoassay

TIMELY RESULTS, TIME-PROVEN TECHNOLOGIES ONE SYSTEM BRINGS IT ALL TOGETHER DxC 700 AU Chemistry Analyzer

Specialty

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Lab Portfolio Lab Lead Form

Beckman Coulter AU Chemistry Analyzers

The introduction of the DxC 700 AU analyzer exemplifies the Beckman Coulter Difference—our commitment to partnering with laboratory professionals to achieve excellence by providing an integrated solution consisting of tools, insights, information management systems and continuous process improvements.

DxC 700 AU CHEMISTRY ANALYZER

Elevating operational efficiency and uptime

› ›

Reducing total cost of ownership

Medline POC

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The DxC 700 AU analyzer supports laboratory excellence by: Enhancing clinical effectiveness through reliable results

Lipid Profile

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The DxC 700 AU chemistry analyzer was designed using input from clinical laboratory professionals. It delivers high uptime, solid reliability and precise performance. With Beckman Coulter’s portfolio of chemistry analyzers, laboratories can rely on standardized results, reagents and workflow—now and in the future—for greater confidence in results.

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Integrating customizable solutions for specific laboratory needs

Chemistry Immunoassay DxC 700 AU: timely results, time-proven technologies

Specialty

Enhancing clinical effectiveness through reliable results When answers are needed quickly and accurate results are critical, laboratories must respond with timeliness and precision. The DxC 700 AU analyzer provides fast, precise answers—in both critical and non-critical situations.

ESR Blood Gas

Securing critical results quickly and accurately

Urgent tests are prioritized with the STAT interrupt feature— a standard on Beckman Coulter chemistry analyzers—offering optimal turnaround time (TAT)

Coagulation

• The operator loads critical samples into the 22-position STAT wheel and presses Start; the STAT sample is then aspirated ahead of routine samples

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Auto repeat of samples that exceed critical values helps ensure accuracy without disrupting workflow

STAT samples are easy to load with minimal impact to workflow.

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Lab Portfolio Beckman Coulter AU Chemistry Analyzers

Lab Lead Form HbA1c and Glucose

Lipid Profile Elevating operational efficiency and uptime Laboratories are under pressure to perform routine and non-routine tasks efficiently to save costs and produce

Medline POC

faster results. The DxC 700 AU analyzer is designed to streamline workflow and provide superior uptime. Routine operations are completed in less time via:

An intuitive design and larger touchscreen monitor, developed

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with input from clinical laboratorians

Real-time status alerts, notifying operators of conditions that could affect sample processing

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Fast startup times and a simplification of daily tasks

Superior uptime

Spend less time on system maintenance and more on

Additional POC

what’s important • Quick and easy parts replacement as a result of Beckman Coulter’s unique “3 & 60” concept for changing out sample and

Urinalysis

reagent probes, mixer bars, syringes, optical lamp and ISEs • Easier reagent management, through the system’s calculation of replenishment needs and its flexibility to load large-capacity containers without disrupting the workflow • Efficient calibrations based on software identification of those assays in need of calibration and simple loading of barcodelabeled calibrators onto the system for easy processing

3 & 60: consumables are replaced in 3 steps within 60 seconds

Hematology Chemistry Immunoassay

Reducing total cost of ownership

Specialty

In today’s changing healthcare climate, laboratories are asked to elevate care and reduce costs at the same time. The low cost of ownership of the DxC 700 AU analyzer helps laboratories achieve their goals while managing resources.

ESR

Reducing laboratory costs

The DxC 700 AU analyzer minimizes economic pressure through the use of:

Blood Gas

• Fewer consumables than other industry same-class systems • Concentrated reagents that take up significantly less storage space than other reagents • Long-lasting ISEs that last a minimum of six months (or 40,000 samples) • Non-disposable cuvettes

Coagulation

Lower your total cost of ownership through fewer consumables, concentrated reagents, long-lasting ISEs and non-disposable cuvettes.

Cardiac 3

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Lab Portfolio Lab Lead Form

Beckman Coulter AU Chemistry Analyzers

HbA1c and Glucose Integrating customizable solutions for specific laboratory needs The DxC 700 AU analyzer is part of the Beckman Coulter total laboratory solution, providing the flexibility to tailor systems based on a laboratory’s volume and space. All Beckman Coulter analyzers offer not only scalability, but also standardization—sharing reagents, operating processes and validation rules—for seamless performance across your network. Transforming laboratory performance through scalability and standardization

Beckman Coulter clinical information management solutions consolidate patient test information and improve sample tracking, providing operators with real-time data and actionable insights to help physicians as they care for patients

The Beckman Coulter Power Link system connects small-footprint automation with chemistry and immunoassay analyzers, providing workcell solutions that can dramatically streamline laboratory processes

Selecting the Beckman Coulter analyzer that meets specific laboratory requirements AU system comparison

AU480

DxC 700 AU

AU5810

Photometric throughput with ISE (tests/hour)

400; 800 with ISE

800; 1,200 with ISE

2,000; 2,900 with single ISE; 3,800 with dual ISE

Number of onboard assays with ISE

63

63

57

Reaction vessel

Non-disposable Non-disposable Non-disposable cuvette cuvette cuvette

Sample volume (µL)

1.0-25.0

1.0-25.0

1.0-17.0

80 (8 racks x Sample load capacity 10 samples)/ (routine/STAT) 22 samples by carousel

150 (15 racks x 10 samples)/ 22 samples by carousel

400 (40 racks x 10 samples)/20 (2 racks x 10 samples) via priority racks

Clot detection and auto-clearing (mechanism)

Yes

Yes

Yes

Open channel capability

Yes

Yes

Lipid Profile Medline POC Influenza A & B / RSV

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Hematology Chemistry Immunoassay The DxC 700 AU can connect to automation, immunoassay and clinical IT solutions.

Specialty

Yes

The DxC 700 AU analyzer is designed for mid-volume hospital laboratories—whether an independent hospital focused on quality and simplicity or as part of an integrated delivery network in need of a standardized chemistry solution for its entire group

Discover how the DxC 700 AU chemistry analyzer can enhance laboratories’ clinical excellence, efficiency and effectiveness. Learn more by contacting a Beckman Coulter

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representative or visiting www.beckmancoulter.com.

Cardiac ©2016 Beckman Coulter, Inc. All rights reserved. Beckman Coulter, the stylized logo and the Beckman Coulter product and service names mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. For Beckman Coulter’s worldwide office locations and phone numbers, please visit www.beckmancoulter.com/contact

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Forms


Lab Portfolio Horiba Pentra 400 Chemistry Analyzer

Lab Lead Form HbA1c and Glucose

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Lab Portfolio Horiba Pentra 400 Chemistry Analyzer

Lab Lead Form HbA1c and Glucose

Lipid Profile

Horiba Pentra 400 Chemistry Analyzer

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Lab Portfolio Horiba Pentra 400 Chemistry Analyzer

Lab Lead Form HbA1c and Glucose

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Lab Portfolio Horiba Pentra 400 Chemistry Analyzer

Lab Lead Form HbA1c and Glucose

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Lab Portfolio Horiba Pentra 400 Chemistry Analyzer

Lab Lead Form

Horiba Pentra 400 Chemistry Analyzer

HbA1c and Glucose

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Lab Portfolio Medtest BS-200 Chemistry Analyzer

Lab Lead Form HbA1c and Glucose

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Hematology Chemistry Immunoassay

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Lab Portfolio Medtest BS-200 Chemistry Analyzer

Lab Lead Form HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

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Lab Portfolio Medtest BS-200 Chemistry Analyzer

Lab Lead Form HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

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Lab Portfolio Medtest BS-200 Chemistry Analyzer

Lab Lead Form HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

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Lab Portfolio Diatron Pictus 500

Lab Lead Form HbA1c and Glucose

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P500 INTELLIGENT WALK AWAY CHEMISTRY

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Lab Portfolio Lab Lead Form

Diatron Pictus 500

HbA1c and Glucose

INTELLIGENT WALK AWAY CHEMISTRY

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC The Diatron P500 is an ergonomically designed, fully automated, random access bench top clinical chemistry system. As a result of its innovative design and advanced Windows-based software, the P500 can achieve a total throughput of up

to 420 tests per hour. The P500 offers features usually only higher cost systems have such as uninterrupted workflow, enhanced walk-away operation and remote access diagnostics, which positioning it as a market leading system.

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Lab Portfolio Diatron Pictus 500

Lab Lead Form HbA1c and Glucose

P500

Lipid Profile Medline POC

FLEXIBILITY State of the art benchtop system with removable reagent tray, host-query LIMS, remote access capability & diagnostics and intuitive, windows based software

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Additional POC

PRODUCTIVITY Continuous sample and reagent loading with on board capacity of 95 samples (5 racks x 19 position) and up to 72 reagent vials + ISE

Urinalysis

Hematology Chemistry Immunoassay

Specialty

ESR Blood Gas

Coagulation RELIABILITY & TRUST Diatron manufactures high performance analysers with best available quality components

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Lab Portfolio Lab Lead Form

Diatron Pictus 500

SPECIFICATIONS

HbA1c and Glucose

Lipid Profile TECHNICAL SPECIFICATIONS • Electrical requirements: 600 VA • Weight: 115 kg, 253 lbs • Dimensions (Width x Depth x Height): 90 cm x 66 cm x 62 cm 35˝ x 26˝ x 24˝ • Water Consumption (l/h): up to 2l • Computer/SW environment: up to Win 10 • Interferential optical filters (340-750 nm): 12 • Photometric range (linearity): -0.1/3.6 • Optical resolution: 0.0001 ABS • Optional direct 3-ISE module (installable by service) • Internal Barcode Reader for samples, sectors and reagents • Halogen Tungsten lamp life with sleep mode 2000 h • Sample and reagent precision of syringe at full stroke: 0.05 % CV GENERAL CHARACTERISTICS • Small to mid-size labs random access analyser (fully automated) • Maximum throughput with ISE: 420 • Temp. controlled cuvette tray via air bath (min maintenance): 37 ± 0.1 °C • Reaction volume: 180-650 μl • Sample volume: 2-200 μl • Cuvette Path/no. of cuvettes on board: 6 mm/80 units • Probes/Pipettes: 1 • Time to first result (seconds): 45

GENERAL CHARACTERISTICS • Removable and interchangeable reagent tray • Refrigerated reagents: 8±2 °C • Refrigerated on-board single reagent vials: 72 • Up to three different reagents per test • Continuously monitored loading/access of reagents • Multiple reagent bottles of the same assay/ test can be on-board (different lots) • On-screen inventory management with real time tracking of on-board reagent availability • Software available in 9 languages SAMPLE HANDLING • Primary, secondary tubes and micro-cups for pediatric samples • Sample Racks/Positions per rack: 5/19 • Samples on-board capacity: 95 • Continuous loading of sample racks • Real STAT function • Automatic sample dilution • Post-analytical tasks such as re-running and post-dilution • Editable complete A4 patient report • Unlimited/searchable patient records

Medline POC Influenza A & B / RSV

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Additional POC Urinalysis

Hematology Chemistry Immunoassay

Specialty

ESR

Analyzer and ISE module SAP No

Description

Catalogue No

10025007

P500 Analyzer without ISE

P500-1

10025008

P500 Analyzer with direct 4-ISE module

P500-2

10021291

Pictus ISE module (module for upgrading Pictus and P models)

5008

10030037

P500 Analyzer without ISE (open)

P500-1-O

10025009

P500 Analyzer with direct ISE module (open)

P500-2-O

Blood Gas

Coagulation Cardiac

We are a member of the STRATEC Group www.diatron.com I sales@diatron.com Diatron reserves the right to change any of the specifications without prior notice. Version Nr. - P500180605USV5

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Lab Portfolio Diatron Pictus 700

Lab Lead Form HbA1c and Glucose

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Pictus 700 THE SMART CHOICE FOR TODAY’S LABORATORY

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Specialty

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Lab Portfolio Lab Lead Form

Diatron Pictus 700

HbA1c and Glucose

ANALYZER OVERVIEW

Lipid Profile Medline POC Influenza A & B / RSV

Strep Diatron’s P700 is a fully automated, random access, small footprint, floor standing chemistry analyzer. Innovatively designed with 2 reaction trays and robotic arms, the system can achieve

a total throughput of up to 720 tests/hour. The P700 incorporates features usually only found in higher cost systems but without the operating expense.

Additional POC Urinalysis

BENEFITS AND KEY FEATURES EFFICIENCY • 95 sample positions • 72 single reagent positions • First results within 45 seconds • Internal optional 4 channel ISE • Optimized walk away operation COST EFFECTIVE AND OPTIMIZED WORKFLOW • Low water consumption (less than 5 l/h) • Minimal consumable usage • Real time reagent inventory control • Real stat sample capacity

EASY TO OPERATE AND LEARN • Windows based operation system • Flexibility for reagents application • Sophisticated features for use and training • Intuitive post dilution and result checking • Graphically represented menus – easy to use icons • Autocal and auto QC features RELIABLE HIGH QUALITY OPERATION • ISE, dilutor, pumps from suppliers of proven technology • Capacitative level sensor • Clot detector • Internal BCR for racks, samples and reagents

Hematology Chemistry Immunoassay

Specialty

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Coagulation Cardiac

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Lab Portfolio Lab Lead Form

Diatron Pictus 700

HbA1c and Glucose

Pictus 700

Lipid Profile Medline POC Influenza A & B / RSV

REAGENT TRAY • 72 position removable reagent tray • Onboard refrigerator • Barcoded reagents

Strep

Additional POC Urinalysis

WASH SYSTEM • Optimized washing system • Automatic cuvette check prior to use • Reusable cuvettes for low operating cost

Hematology Chemistry

Immunoassay

Specialty SAMPLE TRAY • 95 (5 x 19) position barcoded sample racks • Compatible with many sizes of primary tubes and micro tubes • Uninterrupted workflow

ESR Blood Gas

Coagulation MULTIFUNCTIONAL PROBES • Clot, crash and liquid detection on both probes • Pre-heated probe for faster test times • Variable intensity mixer

Cardiac

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Lab Portfolio Diatron Pictus 700

SPECIFICATIONS THROUGHPUT

• Up to 600 photometric tests/hour, max. 720 tests/hour with optional ISE unit SAMPLES AND REAGENT Samples • Sample volume: 2 to 100 μl/test • On-board: 95 (5 racks x 19 positions) ID barcode equipped positions for routine, stat and control samples and standard solutions • Primary, secondary tubes Reagents • Maximum number of reagent vials: 72

• 1 to 3 reagents, 2 to 480 μl/reagent volume each, total volume 180 to 650 μL/test

Lipid Profile

DATA MANAGEMENT

Medline POC

• Bidirectional LIS interface, RS-232C, ASTM E-1381 POWER REQUIREMENTS • 100-240 V, 50/60 Hz, 1,4 kVA

PC REQUIREMENTS

SYSTEM CHARACTERISTICS • Factor or wide selection of calibration modes • Priority selection by sample (profile) or by reagent (batch)

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MEDICA ISE MODULE

Reaction

• Reaction temperature: 37 °C +/- 0.1 °C

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DIMENSIONS • Size: (Width x Depth x Height) 97 cm x 67 cm x 100 cm 38˝ x 26˝ x 39˝ • Weight : 190 kg; 419 lbs

• Barcode Reader for reagents

cuvettes

HbA1c and Glucose

QUALITY CONTROL • Full quality control: Levey-Jennings plots, Westgard multi-rules and twin Youden plots

• Na+, K+, CI-

• Water consumption: Less than 5 l/hour • Reaction cuvette: 160 reusable PMMA 6 mm light path

Lab Lead Form

Additional POC

• WindowsTM 7, 8.1 or 10 computer, 4 GB RAM, 500 GB HDD, DVD-ROM drive, min. 17˝,

Urinalysis

1024 x 768 resolution monitor, keyboard, mouse, 2 RS-232 ports or 2 USB/RS-232 converters, USB ports

Hematology

PRINTERS

• Most printers supported by Windows can be connected

Chemistry

• Automatic curve fit • Routine, batch, STAT, profiles • Automatic sample dilution of abnormal levels, excessive

Immunoassay

substrate consumption and/or lack of linearity

• Automatic backup procedure • Auto re-run • Automatic pre-dilution and post dilution

Specialty

(ratio 1:2 to 1:100)

• Continuous sample loading

ESR

Analyzer and ISE module Description

Catalogue No

SAP No

Pictus 700 Fully automated chemistry analyzer

P700-1

10025301

Pictus 700 with ISE - Fully automated chemistry analyzer with direct ISE module

P700-3

10025302

Pictus ISE module (module for upgrading Pictus and P models)

5008

10021291

Blood Gas

Coagulation Cardiac

We are a member of the STRATEC Group www.diatron.com I sales@diatron.com Diatron US Address: 12601 NW 115th Avenue, Medley, FL 33178, A-113, USA Phone: 833-228-7931 Diatron reserves the right to change any of the specifications without prior notice. Version Nr. P700180620USV7

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Lab Portfolio Lab Lead Form HbA1c and Glucose

Immunoassay Qualigen FastPack® Immunoassay Analyzer

NanoEnTek FREND™ Immunoassay Analyzer

Lipid Profile Medline POC

Beckman Coulter Access 2

Beckman Coulter UniCel DxI

EXCEPTIONAL PRODUCTIVITY IN A COMPACT DESIGN

FastPack® IP System

UniCel DxI ACCESS IMMUNOASSAY SYSTEMS

Access 2 Immunoassay System

Additional POC

Each assay is performed in self-contained FastPacks to provide results in a rapid and convenient format.

VITAMIN D TESTOSTERONE PSA TSH FREE T4 HCG FREE PSA ALPHA-GST

• Easy sample introduction and safe sample handling due to unique self-sealing design • No preparation or reagent additions required • Direct from refrigerator to testing on system — no temperature equilibration required • Improved efficiency — uniform reagent pack design minimizes errors and standardizes training • Simple safe disposable REACTION CHAMBER

SUBSTRATE

WHY WAIT for test results? “Directly diagnose and prescribe at clinics”

Liquid

WASH CHAMBER

Calibration

3 min.

Simple and Fast testing

ANTIBODY SOLUTION

User-friendly Icon

Once a month Liquid Quality Control

6 seconds code chip calibration

Testosterone

Urinalysis

Vitamin D TSH

Please note that some products listed may not be available in all markets.

SAMPLE CHAMBER INJECTION PORT

Strep

A powerful benchtop system that maximizes valuable laboratory space

The FastPack® IP System offers fully automated quantitative immunoassay testing designed for use in any size physician’s office laboratory.

MENU

Influenza A & B / RSV

WASTE CHAMBER

PSA FT4

Hematology Siemens ADVIA Centaur CP

Siemens ADVIA Centaur XPT

Siemens ADVIA Centaur Test Menu

Siemens Immulite 2000 Xpi + Test Menu

Chemistry

ADVIA Centaur, Dimension, EXL, IMMULITE, VersaCell,and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Immunoassay

ADVIA Centaur XPT

Immunoassay System Engineered to Meet the Workload Demands of the Future—Today

System Overview

siemens.com/healthcare Acridinium ester provides cuttingedge assay precision

Simplified operation, training, and reagent management

>70 disease-state assays available

Uninterrupted processing when loading and unloading reagents and consumables

30 primary reagent slots 25 ancillary reagent slots

Allows sample loading on the fly, including a dedicated STAT port

Automated daily maintenance

Processes up to 240 tests per hour

ADVIA Centaur XPT/XP/CP Immunoassay Systems Global Test Menu

Siemens Healthcare Diagnostics unites innovative workflow solutions with clinical excellence in the ADVIA Centaur® family of systems, leading to greater laboratory productivity to stay ahead of increasing workload demands. • Provides sensitivity and specificity you expect of chemiluminescence with Advanced Acridinium Ester Technology • Increases productivity by connecting to Siemens Healthcare Diagnostics Aptio® Automation and VersaCell® Solutions Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84-0

• Utilizes the same ready-to-use reagents are used across all ADVIA Centaur Systems ADVIA Centaur XPT System Siemens Medical Solutions Diagnostics 511 Benedict Avenue Tarrytown, NY 10591-5097 USA

usa.siemens.com/diagnostics

Minimize Your Challenges Today, Before They Magnify Tomorrow

ADVIA Centaur XPT System

Designed with one of the most advanced software packages on the market, the siemens-healthineers.com ADVIA Centaur® XPT System is among the highest-throughput systems available. The ADVIA Centaur XPT System delivers the results that clinicians depend upon for accurate diagnoses and better patient care—and does so predictably and consistently.

siemens-healthineers.com

The high-performance ADVIA Centaur® XP System has extensive onboard reagent capacity Published by and dedicated STAT capabilities to maximize productivity, regardless of volume or types Siemens Healthcare Diagnostics Inc. of tests. Always ready, continuous operation to Diagnostics keep pace with peak workload time. Laboratory ADVIA Centaur CP System

ADVIA Centaur XP System

511 Benedict Avenue Tarrytown, NY 10591-5005

USA The ADVIA Centaur® CP System is a mid-volume, high-throughput benchtop system Phone: +1With 914-631-8000 that enhances your in-house test capabilities. its broad menu and short turnaround times, you can do more—without compromising efficiency, productivity, or quality.

Siemens Medical Solutions Diagnostics

ADVIA Centaur CP Immunoassay System

Order No. 30-18-11502-01-76 | 06-2018 | © Siemens Healthcare Diagnostics Inc., 2018

Tosoh AIA®-900 Immunoassay Analyzer

Specialty

IMMULITE 2000 XPi Immunoassay System

ADVIA Centaur XP System

ADVIA Centaur® CP Immunoassay System

Maximize Your Laboratory’s Potential

Diatron GEMINI (ELISA)

ESR Blood Gas

®

AUTOMATED ENZYME IMMUNOASSAY ANALYZER

Coagulation GEMINI COMPACT MICROPLATE PROCESSOR

Cardiac Tosoh Result Integrity • Multi-Tasking Efficiency TOSOH BIOSCIENCE www.tosohbioscience.us

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Qualigen FastPack Immunoassay Analyzer

HbA1c and Glucose

Lipid Profile Medline POC

FastPack IP System

®

Influenza A & B / RSV

Strep

The FastPack® IP System offers fully automated quantitative immunoassay testing designed for use in any size physician’s office laboratory. Each assay is performed in self-contained FastPacks to provide results in a rapid and convenient format. • Easy sample introduction and safe sample handling due to unique self-sealing design • No preparation or reagent additions required • Direct from refrigerator to testing on system — no temperature equilibration required • Improved efficiency — uniform reagent pack design minimizes errors and standardizes training • Simple safe disposable

MENU

VITAMIN D TESTOSTERONE PSA TSH FREE T4 HCG FREE PSA ALPHA-GST

REACTION CHAMBER

SUBSTRATE

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

ANTIBODY SOLUTION

WASH CHAMBER

Please note that some products listed may not be available in all markets.

Coagulation Cardiac

SAMPLE CHAMBER INJECTION PORT

WASTE CHAMBER

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Qualigen FastPack Immunoassay Analyzer

HbA1c and Glucose

Lipid Profile

FastPack® IP System: The 12 Minute Difference

Medline POC

With its ease of operation and hands-off processing, the FastPack® IP Immunoassay System can help increase the efficiency of your practice and the satisfaction of your patients, without using up your most critical resource — TIME!

Influenza A & B / RSV

Strep

What will 12 minute test results do for you? • Provide laboratory-quality diagnostic results in minutes versus hours/days • Allow you to start or adjust patient therapy in a single visit • Minimize the need for patient call backs • Minimize the need for return visits allowing the opportunity to see more patients • Support a healthier bottom line

Additional POC Urinalysis

Hematology

Whether you are a physician or a member of the office staff, 12 minutes to FastPack® results will help make a difference to your practice and your patients.

Chemistry

Immunoassay

Contact your Sekisui Diagnostics rep today and see how much difference 12 minutes can make!

Specialty

COMPACT & CONVENIENT ESR

9” (23 cm)

13” (33 cm)

Blood Gas 12

”(

30

cm

)

THE AMERICAS

INTERNATIONAL

Sekisui Diagnostics, LLC 4 Hartwell Place Lexington, MA 02421 Phone: 800 332 1042 Fax: 800 762 6311 Email: questions@sekisui-dx.com

Sekisui Diagnostics (UK) Limited Liphook Way, Allington Maidstone, Kent, ME16 0LQ, UK Phone: +44 1622 607800 Fax: +44 1622 607801 Email: info@sekisui-dx.com

Coagulation Cardiac

LIS/Resources

WWW.SEKISUIDIAGNOSTICS.COM MADE IN THE USA

© 2017 Sekisui Diagnostics, LLC. All rights reserved. Because every result matters™ is a trademark of Sekisui Diagnostics, LLC FastPack is a registered trademark of Qualigen Inc.

80-8399-00-00 01/18

Forms


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NanoEnTek FREND Immunoassay Analyzer

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology

WHY WAIT for test results? “Directly diagnose and prescribe at clinics”

Liquid

User-friendly Icon

Testosterone Vitamin D TSH PSA FT4

Immunoassay Specialty

Calibration

3 min.

Simple and Fast testing

Chemistry

Once a month Liquid Quality Control

6 seconds code chip calibration

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


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NanoEnTek FREND Immunoassay Analyzer

HbA1c and Glucose

Lipid Profile

Procedure Testosterone Vitamin D

Medline POC

Insert cartridge

Load sample

Insert AP tube

Influenza A & B / RSV

Get Result

TSH PSA

Strep Add Sample

Insert Cartridge

Get Result

Additional POC FT4

Incubate cartridge and Tube

Add Sample

Insert Cartridge

Urinalysis

Get Result

Hematology

Specification FREND Testosterone

FREND Vitamin D

FREND TSH

FREND PSA

FREND Free T4

Analytical measurement range

20 ~ 1500 ng/dL

13 ~ 96 ng/mL

0.06 ~ 25 mlU/L

0.08 ~ 25 ng/mL

0.4 ~ 6.0 ng/dL

Sample type

Plasma or Serum

Plasma or Serum

Plasma or Serum

Plasma or Serum

Plasma or Serum

Sample volume

35 µL

35 µL

35 µL

35 µL

35 µL

Limit of detection

20 ng/dL

13 ng/mL

0.06 mlU/L

0.08 ng/mL

0.4 ng/dL

Reaction time

< 3 min.

< 3 min.

< 3 min.

< 3 min.

< 3 min.

Pretreatment method

AP / Heat block (5 min.)

AP (15 min.)

N/A

N/A

Heat block (5 min.)

1 box

20 tests

20 tests

25 tests

25 tests

20 tests

Storage condition

2˚C ~ 8˚C

2 ˚C ~ 8 ˚C

2˚C ~ 8˚C

2 ˚C ~ 8 ˚C

* Total assay time depends on pretreatment procedure.

* Total assay time depends on pretreatment procedure.

TM

TM

TM

TM

TM

Chemistry

Immunoassay

2˚C ~ 8˚C

Specialty

* Total assay time depends on pretreatment procedure.

Correlation graph Vitamin D

Testosterone

TSH

PSA

120

16.00

6

y = 0.9578x + 0.3018

14.00

R2 = 0.9539

ESR

Free T4

100

y = 1.0421x + 0.5738

y = 0.9509x + 0.0267

y = 0.9364x + 0.263

R2 = 0.947

R2 = 0.9849

R2 = 0.9663

y = 1.010x + 0.057 R2 = 0.9721

5

12.00 10.00 8.00 6.00

80

4

60

3

40

2

20

1

Blood Gas

4.00 2.00

0

0.00

0.00

2.00

4.00

6.00

8.00

10.00

12.00

0 0

14.00 16.00

20

40

60

80

100

Predicate devices B (ng/mL)

0

Laboratory equipment ( µIU/mL)

Laboratory equipment ( ng/dL)

1

2

3

4

5

6

Laboratory equipment ( ng/dL)

Products Code Cat. No

Item

FRTE 020

84403

FREND Vitamin D

FRVD 020

82306

FREND TSH

FRTS 025

84443

FREND PSA

FRPS 025

84153

FREND Free T4

FRT4 020

84439

TM

TM

TM

TM

e-mail website

sales@nanoentek.com www.nanoentek.com

NanoEnTek Inc. (USA) 240 Bear Hill Road, Suite 101, Waltham, MA 02451, USA Tel: +1-781-472-2558, +1-888-988-0108(Toll free) / Fax: +1-781-790-5649

CPT Code

FREND Testosterone TM

NESCT-FRD-002E ( V.0.3)

Coagulation Cardiac

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Beckman Coulter Access 2 Immunoassay Analyzer

HbA1c and Glucose

Lipid Profile

EXCEPTIONAL PRODUCTIVITY IN A COMPACT DESIGN A powerful benchtop system that maximizes valuable laboratory space Access 2 Immunoassay System

Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Beckman Coulter Access 2 Immunoassay Analyzer

Lab Lead Form HbA1c and Glucose

Lipid Profile

PROVEN ANALYTICAL PERFORMANCE. SPACE-SAVING VALUE.

Medline POC Influenza A & B / RSV

The Access 2 contains the robustness of a reference laboratory immunoassay analyzer in the convenient size of a benchtop system, providing greater control over performance, reliability and speed without sacrificing valuable laboratory space.

Strep

Additional POC Urinalysis

Benefits of the Access 2 immunoassay system Maximized productivity in a minimal footprint › Throughput of up to 100 tests per hour › One of the smallest footprints in its class › Loading capacity of 60 samples at one time › Random access for running any combination of samples at any time › Rapid kinetics for improved turnaround time › STAT and automatic reflex testing Reliable uptime with fewer emergency service calls › Sample probe obstruction detection › Remote monitoring and instrument diagnostics capability through PROService Established performance for confidence in patient results › Utilizes Proven chemiluminescent and magnetic particle separation technology › Unique, assay-specific protocols for optimal assay performance Lower operating costs › Onboard refrigerated storage of up to 24 assays › 50 tests per pack+ › No dedicated water system required Intuitive interface and improved ergonomics simplify operation › Customer-friendly user interface with color-coded, icon-driven touch screen › Internal barcode reader for automatic identification of reagent packs upon loading, minimizing operator loading errors › Ergonomic workstation with flexible movement for comfort for system operators › Status bar indicator light for easy visibility of system status from across the laboratory

Hematology Chemistry

Immunoassay Specialty

ESR Blood Gas

Coagulation Cardiac

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Beckman Coulter Access 2 Immunoassay Analyzer

Standardization simplifies and improves operational efficiencies

HbA1c and Glucose

All Access immunoassay systems feature standardized test menus, assay protocols, instrument processes and reference ranges. Together, these features minimize training requirements and streamline inventory management tasks for labor-cost savings, while

Lipid Profile

providing consistent results across the healthcare delivery network.

Medline POC

Comprehensive training and top-tier support increases productivity Beckman Coulter is committed to ensuring its diagnostic testing solutions meet the highest standards and integrate seamlessly into different laboratory environments. The Access 2 comes complete with the training and support needed to get it up and running as quickly as possible.

› Training provided (advanced operator training also available) › Online maintenance help › Dedicated customer service and support to meet current and future needs

Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

The Beckman Coulter Diagnostics Difference Beckman Coulter has invested in a synergistic portfolio of products and services for modern healthcare enterprises that are scalable to fit laboratories of any size. This portfolio includes more than clinical diagnostic products and services; it also includes clinical IT solutions, the Danaher Business System, and our top-tier service and uptime solutions. These four elements work together in synergy to help our customers achieve laboratory excellence. We call it “the Beckman Coulter Diagnostics Difference.”

Immunoassay

Specialty

ESR Blood Gas

DANAHER BUSINESS SYSTEM

COMPREHENSIVE, HIGH-QUALITY CLINICAL DIAGNOSTIC SOLUTIONS CLINICAL INFORMATION MANAGEMENT TOOLS

Coagulation Cardiac

TOP-TIER SERVICE AND UPTIME

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Beckman Coulter Access 2 Immunoassay Analyzer

ACCESS IMMUNOASSAY MENU Adrenal/Pituitary › Cortisol (Serum, Plasma, Urine) Anemia › Active B12* › EPO › Ferritin › Folate › Folate (RBC) › Intrinsic Factor Ab › sTfR › Vitamin B12 Bone metabolism › 25(OH) Vitamin D Total › Intact PTH (Routine or Intraoperative) › Ostase › Ultrasensitive hGH Cardiac › AccuTnI+3 (Troponin I) › CK-MB › Digoxin › hsTnI* › Myoglobin › Triage BNP** Diabetes › Ultrasensitive Insulin Infectious disease › Rubella IgG › Toxo IgG › Toxo IgM II

Reproductive › AFP (ONTD) › AMH › DHEA-S › hFSH › hLH › Inhibin A › Progesterone › Prolactin › Sensitive Estradiol › SHBG › Testosterone › Total βhCG (5th IS) › Unconjugated Estriol Thyroid › T3 (Free and Total) › T4 (Free and Total) › Thyroglobulin › Thyroglobulin Ab II › Thyroid Uptake › TPO Ab › TSH (3rd IS) Tumor markers › AFP › CEA › BR Monitor (CA 15-3 Antigen) › GI Monitor (CA 19-9 Antigen) › OV Monitor (CA 125 Antigen) › Prostate Health Hybritech PSA Hybritech free PSA Hybritech p2PSA Prostate Health Index (phi)*** Research use only › PAPP-A (RUO) › IL-6 (RUO)

Access immunoassay menu Beckman Coulter offers an extensive immunoassay diagnostic testing menu to fulfill patient-care needs. › More than 50 diagnostic immunoassays available › Multiple assays available for different diagnostic specialties Easy-to-use, easy-to-store reagent kits The Access 2 uses liquid, ready-to-use reagent packs that contain everything needed to run an assay in one convenient container. › Slim-line design, facilitating facilitates easy pack loading › Self-sealing elastomer closure › No caps, preventing potential probe crashes › Easy-to-store kit boxes maximize refrigerator space › Typical shelf life of 12 months

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay Specialty

ESR Blood Gas

Coagulation + TSH (3rd IS) is available in 100-test pack. * In development. ** Available exclusively from Quidel or its authorized distributors for use on Beckman Coulter immunoassay systems.

Cardiac

*** phi is a combination of Hybritech PSA, free PSA and p2PSA.

Brochure is intended for the United States. Contact your local Beckman Coulter sales representative for availability. © 2018 Beckman Coulter, Inc. All rights reserved. Beckman Coulter, the stylized logo and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. For Beckman Coulter’s worldwide office locations and phone numbers, please visit www.beckmancoulter.com/contact

BR-27150 WF#BR-64659

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Lab Portfolio Beckman Coulter UniCel DxI

Lab Lead Form HbA1c and Glucose

Lipid Profile

UniCel DxI ACCESS IMMUNOASSAY SYSTEMS

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


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Beckman Coulter UniCel DxI

HbA1c and Glucose

WHEN IT COMES TO IMMUNOASSAY TESTING, MID- TO HIGH-VOLUME LABORATORIES HAVE SPECIFIC NEEDS › Exceptional productivity › Ease-of-use › Broad menu availability › Expandability

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

The UniCel DxI family of immunoassay systems is the solution.

Urinalysis Hematology

Chemistry

Immunoassay Specialty

UniCel DxI 800

UniCel DxI 600

Throughput and consistency The UniCel DxI family of analyzers is designed to meet the throughput needs of any mid- or high-volume laboratory. Whether it is the DxI 600, that can run up to 200 tests per hour, or the high-speed DxI 800, with a maximum throughput of up to 400 tests per hour, each DxI analyzer uses the same proven chemiluminescent technology, the same reagent packs and the same assay protocols. So, your laboratory can deliver consistent patient results, no matter which UniCel immunoassay system performs the test. Equivalent patient results simplify interpretation by physicians, which helps improve patient care.

For the laboratory, consistency between analyzers adds more benefits: › Operator training is simplified and reduced › Inventory management is less time-consuming › Reliable system operation is achieved through proven technology

ESR Blood Gas Coagulation

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Beckman Coulter UniCel DxI

HbA1c and Glucose

Lipid Profile

AUTOMATION FOR PEAK PRODUCTIVITY Proven analytical performance The core of the UniCel DxI is Beckman Coulter’s proven chemiluminescent detection and magnetic particleseparation technology. Unlike other immunoassay systems, the DxI analyzer uses multiple assay protocols so that assay performance is not compromised. › Excellent precision and sensitivity through chemiluminescence technology › Chemiluminescent detection helps eliminate reaction noise and delivers a more accurate result › Rapid assay kinetics improve the turnaround time for many assays

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Ingenious system design Under the sleek covers of the UniCel DxI instruments are a system of multiple, auto-matched pipettors working in parallel to deliver sample and reagent into the reaction vessels— achieving a peak throughput of up to 400 immunoassay tests per hour. Each independent pipettor utilizes the same assay protocols as other systems in the family. › Multiple pipettors offer built-in redundancy for maximum system uptime › Process monitoring provides confidence in the integrity of results › Probe wash tower efficiently cleans sample probes, eliminating the need for disposable tips › Pick-and-place vessel transport technology works with the process scheduler to make sure throughput and assay performance are optimized

Specialty

ESR Blood Gas Coagulation

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Lab UniCel DxI The Portfolio DESIGNED WITH YOUR NEEDS IN MIND Beckman Coulter UniCel DxI

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Onboard aliquot capability The UniCel DxI system creates aliquots based on the volume of requested tests plus any additional volume required for user-defined reflex or repeat test scenarios. To maintain sample stability and facilitate any additional testing required, the system stores the aliquots for up to three hours in a refrigerated storage area. This unique aliquot capability of the UniCel DxI helps improve your laboratory workflow. › The automatic reflex capability eliminates the task of tracking down sample tubes and reloading them › The same vessel type is used for aliquots and reactions

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

› Automated onboard dilution › Allows on-system user-defined reflex conditions and repeat testing for automatic dilutions

Streamlined sample handling With a UniCel DxI system, operators will experience high throughput with consistent rack loading that won’t interrupt system operation. Our instruments are designed to meet various throughput needs with streamlined sample handling. The UniCel DxI 600 has a 60-specimen capacity with 200 tests per hour, and the UniCel DxI 800 has a 120-specimen capacity with 400 tests per hour. › The system automatically creates aliquots of the sample, so each rack is released in less than five minutes for testing in other areas of the laboratory › Routine sample loading can be interrupted to load STAT samples quickly—your laboratory can take advantage of the system’s full menu without impacting the throughput of STAT assays › Radio frequency sensors on the sample probe alert operators to short samples › Obstruction detection on the sample and reagent probes helps ensure sample integrity and accurate results › Sample probes are washed after each aliquot, eliminating the need for disposable tips and preventing possible carry-over › By releasing the primary tube quickly, the system allows for continuous loading of routine samples, virtually eliminating bottlenecks

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


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Beckman Coulter UniCel DxI

HbA1c and Glucose

Simplicity in motion The UniCel DxI systems deliver high throughput with minimal operator intervention. Although extremely powerful, the UniCel DxI systems are amazingly simple to use. › Operators can load all reagents and consumables “onthe-fly” without using the console computer › Operators can still access the system from the front for STATs, calibrators and other sample exceptions › Indicator lights alert operators to system status and a pictogram shows which supplies need replenishment

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

› The system delivers up to three hours of walkaway operation

Additional POC

Efficient reagent system Barcoded, liquid, ready-to-use reagents can be loaded on the system quickly and easily. The system holds 50 selfresealing reagent packs, which gives you the flexibility to configure the system menu to match your testing requirements. › Load up to four reagent packs at a time without touching the system console

Urinalysis Hematology

Chemistry

› Each reagent pack contains everything needed to run an assay in one single convenient container › System maintains stored reagents in an on-board refrigerator, maintaining reagent stability up to labeled expirations dates › Reagent packs are compatible with other UniCel systems

Immunoassay Specialty

› Easy-to-use liquid calibrators for almost all assays

ESR

Intuitive user interface

Operators find the graphical user interface with touch screen capability very easy to use. Manual test requests, calibration and QC can be accomplished in just a few steps, reducing operator time. › The software includes context-sensitive help to facilitate troubleshooting and operator training › Laboratories equipped with other UniCel systems will find many similarities in the user interface screens and system operation, which expedites operator training

Blood Gas Coagulation

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Lab Portfolio Beckman Coulter UniCel DxI

Lab Lead Form HbA1c and Glucose

INNOVATION DELIVERS POWERFUL EFFICIENCY Remote monitoring PROService is an optional, remote management system that continuously monitors Beckman Coulter instruments to identify problems before they become evident in the laboratory. If a parameter goes out of normal range (e.g., temperature, power or vacuum pressure) PROService automatically alerts the Beckman Coulter support center. A call center agent may then contact your laboratory and, with permission, perform further diagnosis or actual system correction. If a service visit is necessary, your Field Service Engineer (FSE) is able to bring exactly the right parts and supplies needed to correct the problem. Additional benefits: › Decrease in workflow disruptions that may be caused by an onsite FSE presence › Beckman Coulter’s PROService Alert Triggers communicate predictive failures to support teams for review before an unexpected downtime scenario › The time-to-resolution is decreased with remote monitoring, triage and repair, so customers can return to normal operation as quickly as possible. Remote monitoring can eliminate travel of service engineers to a customer’s site which can decrease the time it takes to resolve the problem helping to ensure a higher level of business continuity— sustained testing, less downtime › Benefit from immediate and accurate diagnosis. Help is only a mouse click away for instant remote support from trained Beckman Coulter personnel. Their toolsets ensure timeliness and accuracy. If parts are required, they can be shipped and an FSE can be onsite (if needed)

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay Specialty

ESR Blood Gas Coagulation

Minimal maintenance means more uptime › Minimal “hands-on” daily maintenance and no weekly maintenance increases instrument uptime, enhancing productivity › A wide array of advanced sensors monitor system status and test processing to ensure result integrity › Automated “behind-the-scenes” cleaning procedures ensure optimal instrument performance

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Beckman Coulter UniCel DxI

ACCESS IMMUNOASSAY MENU Adrenal/Pituitary Cortisol (Serum, Plasma, Urine) Allergy Total IgE Anemia Active B12* EPO Ferritin Folate Folate (RBC) Intrinsic Factor Ab sTfR Vitamin B12 Bone metabolism 25 (OH) Vitamin D Total Intact PTH (Routine or Intraoperative) Ostase Ultrasensitive hGH Cardiovascular AccuTnl+3 (Troponin I) CK-MB Digoxin hsTnI* Myoglobin Triage BNP† Diabetes Ultrasensitive Insulin Inflammation IL-6 (RUO)** Infectious disease Rubella IgG Toxo IgG Toxo IgM II

Reproductive AFP (ONTD) AMH (RUO)*** DHEA-S Estradiol hFSH hLH Inhibin A PAPP-A (RUO)**** Progesterone Prolactin Sensitive Estradiol* SHBG Testosterone Total βhCG (5th IS) Unconjugated Estriol Thyroid T3 (Free and Total) T4 (Free and Total) Thyroglobulin Thyroglobulin Ab II Thyroid Uptake TPO Ab TSH (3rd IS)§ Tumor markers AFP CEA BR Monitor (CA 15-3 Antigen) GI Monitor (CA 19-9 Antigen) OV Monitor (CA 125 Antigen)

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

With a broad menu across a wide variety of disease states, the UniCel DxI immunoassay system enables your laboratory to consolidate workstations. An aggressive menu development program means that the system menu will grow as your lab and testing requirements grow.

Prostate health Hybritech PSA Hybritech Free PSA Hybritech p2PSA Prostate Health Index (phi)‡

ENTRY AUTOMATION Clinical laboratories of all sizes are facing ever-increasing demands for broader test menu, rapid test turnaround times and optimal workflow with reduced human intervention. The Power Link system, which links an AU680 chemistry system and DxI immunoassay AU680 Power Link UniCel DxI 600 or 800 analyzer into an entry-level automated system, is designed to meet the needs of medium-to-high test volume laboratories. The Power Link system offers a flexible, single-specimen workflow, eliminating the complexity and bottlenecks of aliquotting or rack-based systems. The Power Link system offers complex, rules-based sample and data management capabilities with labor savings and ease of service.

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Beckman Coulter UniCel DxI

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC Contact your local Beckman Coulter sales representative for availability. * In development ** Research use only (RUO) *** AMH is an RUO in US and IVD in Canada. **** PAPP-A is an RUO in the U.S. It is an IVD in Canada. † Available exclusively from Alere or its authorized distributors for use on Beckman Coulter immunoassay systems. Alere and Triage are trademarks of the Alere group of companies. ‡ phi is a combination of Hybritech PSA, free PSA and p2PSA. § Pending clearance by the U.S. FDA; not available for in vitro diagnostic use in the U.S.

Urinalysis Hematology

Chemistry For distribution in the U.S. and Canada only. ©2016 Beckman Coulter, Inc. All rights reserved. Beckman Coulter, the stylized logo and the Beckman Coulter product and service names mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. For Beckman Coulter’s worldwide office locations and phone numbers, please visit www.beckmancoulter.com/contact BR-51666

Immunoassay

Specialty

ESR Blood Gas Coagulation

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Lab Portfolio Siemens ADVIA Centaur CP

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas

Minimize Your Challenges Today, Before They Magnify Tomorrow ADVIA Centaur® CP Immunoassay System

Coagulation

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Siemens Medical Solutions Diagnostics

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Lab Portfolio Lab Lead Form

Siemens ADVIA Centaur CP

HbA1c and Glucose

Tomorrow, You’ll Have Less Time, Space, and Staff. Are You Prepared to Face the Challenge?

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Be Ready with ADVIA Centaur CP Immunoassay System

Additional POC

Urinalysis Does your system have a limited menu? Are too many send-out tests driving up costs?

Does your system bottleneck at peak times and have slower than needed TATs?

You need an immunoassay system with the capacity to handle your growing test volume. ADVIA Centaur CP is a compact, high-performance benchtop immunoassay system that enhances your in-house testing capability with a broad menu of assays. So now you have the power to maximize productivity, expand capacity, and bring more tests in-house— no matter how large your workload.

You need a solution that consistently performs faster, delivers more predictable TATs, and maintains speed and accuracy even during peak workload times. With ADVIA Centaur CP, you can stay ahead of your growing test volume, maximize productivity, and meet the growing needs of your lab in less time.

Does it take multiple systems to complete your menu? Are they taking over your lab? You need a compact, powerful immunoassay analyzer that minimizes space requirements. ADVIA Centaur CP makes it possible to expand and consolidate at the same time. It eliminates the need for multiple systems by giving you a broad assay menu. So now you can increase your lab’s efficiency by bringing a wide range of assays onto a single workstation—and take back your lab.

Do you expect your test volume to increase? Will you have the staff to handle it? You’re under pressure to deal with sharply rising workloads at the same time your staff is shrinking and it’s only going to get worse over time. ADVIA Centaur CP lets you do more with fewer resources. It’s easy to operate, increases efficiency, and streamlines workflow, with the added benefit of eliminating redundant or antiquated systems.

Meet the Increasing D

The ADVIA Centaur CP is the hig Hematology empowers you to overcome th delivering a broader menu, sh do more with fewer resources—

Chemistry

More Predictable TATs

• STAT port guarantees priority s at any time Immunoassay • Delivers shorter TATs on both r and STAT tests • Routine test results available in 15 minutes, on average; for ex Specialty B12/folate • High throughput, up to 180 te hour, and two to three hours w capacity enable you to keep pa ESR times peak workload

Enhanced Menu Capacity

Blood Gas

• ADVIA Centaur CP offers a comprehensive disease-state m and will continue to expand w Coagulation addition of infectious disease a • Disposable tips eliminate carry critical for infectious disease te • 15 onboard reagents maximize Cardiac test capacity

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Siemens ADVIA Centaur CP

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

Meet the Increasing Demands of Your Lab Hematology

The ADVIA Centaur CP is the high-throughput benchtop immunoassay system that empowers you to overcome the challenges you face today and tomorrow. By delivering a broader menu, shorter TATs, and enhanced consolidation, you can do more with fewer resources—without compromising efficiency or productivity. More Predictable TATs

Practical Productivity

• STAT port guarantees priority sampling at any time • Delivers shorter TATs on both routine and STAT tests • Routine test results available in 15 minutes, on average; for example, B12/folate • High throughput, up to 180 tests per hour, and two to three hours walkaway capacity enable you to keep pace with peak workload times

• Combining the ADVIA Centaur CP with the ADVIA® 1200 Chemistry System and the ADVIA CentraLink® data management system offers superb speed and turnaround time for chemistry and immunoassay testing needs • “Always ready” feature allows true continuous operation. This enables the operator to attend to most functions, including loading samples, reagents, and most consumables or emptying the waste without pausing or interrupting the test processing • The ADVIA Centaur CP uses the same reagent packs, ancillary, consumables, and wash as the ADVIA Centaur and the ADVIA Centaur XP. This commonality of reagents and consumables allows an easier and more efficient management of inventory • ADVIA Centaur CP, in conjunction with the Centaur, provides standardization of results between satellite labs and the core or reference laboratory • Easy maintenance procedures require minimal operator time • Remote connectivity capability allows for remote software upgrades and remote diagnostics, which will help minimize system downtime and provide quicker resolution of issues*

Enhanced Menu Capacity • ADVIA Centaur CP offers a comprehensive disease-state menu and will continue to expand with the addition of infectious disease assays • Disposable tips eliminate carryover, critical for infectious disease testing • 15 onboard reagents maximize test capacity

Chemistry

Immunoassay Specialty

ESR Blood Gas Coagulation ADVIA Centaur CP Disease-State Assay Group Anemia Bone Metabolism Cardiovascular Infectious Disease Reproductive Endocrinology TDM Thyroid Function Tumor Markers ®

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Siemens ADVIA Centaur CP

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC Siemens Medical Solutions Diagnostics offers a broad portfolio of performance-driven diagnostic solutions that provide more effective ways to assist in the diagnosis, monitoring, and management of disease. Our products and services bring together the right balance of science, technology, and practicality across the healthcare continuum to empower medical professionals with the vital information they need to deliver better, more personalized care to patients around the globe.

Urinalysis Hematology

Chemistry

© 2007, Siemens Medical Solutions Diagnostics Order No. A91DX-0700716-C2-4A00 Printed in USA ADVIA, ADVIA Centaur, ADVIA CentraLink, and all associated marks are trademarks of Siemens Medical Solutions Diagnostics. All other trademarks and brands are the property of their respective owners.

Immunoassay Specialty

Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

ESR

*In development.

Blood Gas Siemens Medical Solutions Diagnostics 511 Benedict Avenue Tarrytown, NY 10591-5097 USA

Coagulation Minimize

Before Th

Cardiac ADVIA Centa LIS/Resources www.siemens.com/diagnostics

Siemens Medical S

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Lab Portfolio Siemens ADVIA Centaur XPT

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

ADVIA Centaur XPT

Strep

Immunoassay System Engineered to Meet the Workload Demands of the Future—Today

Additional POC System Overview

Acridinium ester provides cuttingedge assay precision

Simplified operation, training, and reagent management

>70 disease-state assays available

Uninterrupted processing when loading and unloading reagents and consumables

30 primary reagent slots 25 ancillary reagent slots

Allows sample loading on the fly, including a dedicated STAT port

Automated daily maintenance

Processes up to 240 tests per hour

Urinalysis Hematology

Chemistry

Immunoassay Specialty

ESR Blood Gas usa.siemens.com/diagnostics

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Siemens ADVIA Centaur XPT

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

ADVIA Centaur XPT System

New Software Capabilities Software Provides Simplified Operation and Training

The information in this document contains general technical descriptions of specifications and options as well as standard and optional features, which do not always have to be present in individual cases.

Simplified, stress-free reagent management

Ability to automatically track and graph temperature and humidity

Easy interpretation of results using visual icons

Automatic QC/cal order scheduling

System tracks ALL operator actions

Connect to all Siemens Healthineers automation, CentraLink® system, and Siemens Remote Service

Calibration curves can be stored for multiple lots; calibration alerts can be programmed

On account of certain regional limitations of sales rights and service availability, we cannot guarantee that all products included in this brochure are available through the Siemens sales organization worldwide. Availability and packaging may vary by country and is subject to change without prior notice. Some/All of the features and products described herein may not be available in the United States.

Stores up to 1 million records, with ability to export to USB, DVD, or LIS

Siemens reserves the right to modify the design, packaging, specifications, and options described herein without prior notice. For the most current information, please contact your local sales representative from Siemens. Note: Any technical data contained in this document may vary within defined tolerances. Original images always lose a certain amount of detail when reproduced. Siemens Healthcare Diagnostics, a global leader in clinical diagnostics, provides healthcare professionals in hospital, reference, and physician office laboratories and point-of-care settings with the vital information required to accurately diagnose, treat, and monitor patients. Our innovative portfolio of performance-driven solutions and personalized customer care combine to streamline workflow, enhance operational efficiency, and support improved patient outcomes. ADVIA Centaur, IMMULITE, Dimension Vista, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Phone: +49 9131 84-0 siemens.com/healthineers

Order No. A91LD-CAI-17441-P1-4A00 | Printed in USA 02-2017 | © Siemens Healthcare Diagnostics Inc., 2017

Local Contact Information Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591-5005 USA Phone: +1-888-826-9702 usa.siemens.com/diagnostics

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens ADVIA Centaur Test Menu

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis

siemens.com/healthcare

ADVIA Centaur XPT/XP/CP Immunoassay Systems Global Test Menu

Chemistry

Immunoassay

Siemens Healthcare Diagnostics unites innovative workflow solutions with clinical excellence in the ADVIA Centaur® family of systems, leading to greater laboratory productivity to stay ahead of increasing workload demands.

Specialty

• Provides sensitivity and specificity you expect of chemiluminescence with Advanced Acridinium Ester Technology • Increases productivity by connecting to Siemens Healthcare Diagnostics Aptio® Automation and VersaCell® Solutions • Utilizes the same ready-to-use reagents are used across all ADVIA Centaur Systems

Hematology

ESR ADVIA Centaur XPT System

ADVIA Centaur XPT System

Blood Gas

Designed with one of the most advanced software packages on the market, the ADVIA Centaur® XPT System is among the highest-throughput systems available. The ADVIA Centaur XPT System delivers the results that clinicians depend upon for accurate diagnoses and better patient care—and does so predictably and consistently.

Coagulation

ADVIA Centaur XP System The high-performance ADVIA Centaur® XP System has extensive onboard reagent capacity and dedicated STAT capabilities to maximize productivity, regardless of volume or types of tests. Always ready, continuous operation to keep pace with peak workload time.

ADVIA Centaur XP System

Cardiac

ADVIA Centaur CP System The ADVIA Centaur® CP System is a mid-volume, high-throughput benchtop system that enhances your in-house test capabilities. With its broad menu and short turnaround times, you can do more—without compromising efficiency, productivity, or quality.

LIS/Resources

ADVIA Centaur CP Immunoassay System

Forms


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HbA1c and Glucose

ADVIA Centaur XPT/XP/CP Immunoassay Systems Global Test Menu

Lipid Profile

♦ ADVIA Centaur® XPT System

▲ ADVIA Centaur® XP System ● ADVIA Centaur® CP System

Hepatitis

Allergy ● IgE, Total

♦ ▲

Anemia ♦ ▲ ●* Active-B12 ♦* ▲* ●* EPO †

♦ ♦ ♦ ♦

▲ ▲ ▲ ▲

♦ ▲

● ● ● ●

Ferritin Folate RBC Folate Vitamin B12

Autoimmune ● Anti-CCP Bone Metabolism

● Intact PTH ♦ ▲ ●* Vitamin D Total ♦ ▲

Cardiac ♦ ♦ ♦* ♦†

▲ ▲ ▲* ▲†

● ● ●* ●*

BNP CKMB Galectin-3 High-Sensitivity Troponin I (TNIH) ♦ ▲ ● Myoglobin ♦† ▲† ●† NT-proBNP ♦ ▲ ● Tnl-Ultra™ Diabetes ♦ ▲ ♦ ▲

● C-Peptide ● Insulin

♦† ▲ † ● † ♦ ▲ ● ♦ ▲ ● ♦ ▲ ● ♦ ▲ ● ♦ ▲ ● ♦ ▲ ♦ ▲ ●† ♦† ▲ †

HBeAb HBsAb 2 HAV IgM HAV Total HBc IgM HBc Total HBeAg HBsAgII HBsAgII Quant ♦ ▲ ● HBsAg ♦ ▲ ● HBsAg Confirmatory ♦‡ ▲‡ ●‡ HCV §

§

§

HIV

● HIV 1/O/2 Enhanced (EHIV) ♦‡ ▲‡ ●†‡ HIV Combo ♦ ▲ ‡

Immunosuppressant Drugs ♦ ▲

● Cyclosporine

♦* ▲* ●* Everolimus ♦* ▲* ●* Sirolimus

♦* ▲* ●* Tacrolimus

Inflammation ♦* ▲* ●* IL-6 ♦* ▲* ●* LBP

Liver Fibrosis

♦† ▲† ●† Enhanced Liver Fibrosis

(ELF™) Test

♦† ▲† ●† HA (ELF™ Marker) ♦† ▲† ●† PIIINP (ELF™ Marker) ♦† ▲† ●† TIMP (ELF™ Marker)

Metabolic ♦* ▲* ●* ACTH ♦ ▲ ● Cortisol ♦ ▲ ● Homocysteine

Oncology ♦† ♦ ♦ ♦ ♦ ♦* ♦ ♦ ♦† ♦ ♦

▲ ▲ ▲ ▲ ▲ ▲* ▲ ▲ ▲† ▲ ▲

● ● ● ● ● ●* ● ●

AFP BR 27.29 CA 125II CA 15-3 CA 19-9 Calcitonin CEA Complexed PSA Free PSA ● PSA ● Serum HER-2/neu

Reproductive Endocrinology ♦† ♦* ♦ ♦ ♦* ♦ ♦ ♦ ♦* ♦* ♦ ♦ ♦* ♦ ♦

▲ ▲* ▲ ▲ ▲* ▲ ▲ ▲ ▲* ▲* ▲ ▲ ▲* ▲ ▲

● ●* ● ● ●* ● ● ● ●* ●* ● ● ●* ● ●

AFP Anti-Müllerian Hormone DHEAS Enhanced Estradiol Free βhCG FSH hCG LH

PAPP-A

PIGF Progesterone Prolactin sFLT-1 SHBG Testosterone II

Sepsis

Medline POC

♦† ▲† ●† Procalcitonin

♦ ▲

Special ID ● Syphilis

Influenza A & B / RSV

Therapeutic Drug Monitoring (TDM) ♦ ♦ ♦ ♦ ♦ ♦ ♦ ♦ ♦

▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲

● ● ● ● ● ● ● ● ●

Carbamazepine Digitoxin Digoxin Gentamicin Phenobarbital Phenytoin Theophylline Valproic Acid Vancomycin Thyroid

♦ ♦ ♦ ♦ ♦ ♦ ♦ ♦ ♦

▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲ ▲

● ● ● ● ● ● ● ● ●

Anti-Tg Anti-TPO Free T3 Free T4 T Uptake Total T3 Total T4 TSH3-Ultra TSH ToRCH

♦* ♦* ♦† ♦† ♦ ♦ ♦ ♦

▲* ▲* ▲† ▲† ▲ ▲ ▲ ▲

●* ●* ●† ●† ● ● ● ●*

CMV IgG CMV IgM Herpes-1 IgG Herpes-2 IgG Rubella IgG Rubella IgM Toxoplasma IgG Toxoplasma IgM

* Under development. Not available for sale. † Not available for sale in the U.S. ‡ The ADVIA Centaur HCV and HIV assays are developed, manufactured and sold by Siemens for Ortho-Clinical Diagnostics, Inc. and Grifols Diagnostic Solutions Inc. § Not CE marked

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay Specialty

ESR Blood Gas

ADVIA, ADVIA Centaur, Aptio, ELF, Tnl-Ultra, VersaCell, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Local Contact Information Siemens Healthcare Diagnostics Inc. Laboratory Diagnostics 511 Benedict Avenue Tarrytown, NY 10591-5005 USA Phone: +1 914-631-8000 siemens.com/healthcare

Siemens Healthcare Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Phone: +49 9131 84-0 siemens.com/healthcare

Order No. A91DX-CAI-170132-GC1-4A00 | 09-2017 | © Siemens Healthcare Diagnostics Inc., 2017

Coagulation

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Lab Portfolio Siemens Immulite 2000 Xpi + Test Menu

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Maximize Your Laboratory’s Potential

Specialty

ESR

IMMULITE 2000 XPi Immunoassay System Blood Gas

siemens-healthineers.com Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Siemens Immulite 2000 Xpi + Test Menu

HbA1c and Glucose

How will a broad menu, proven reliability, and simplification maximize your potential?

Innov

Lipid Profile

Medline POC Advanced Performance Features • Auto Rack Loading allows sample racks to be placed on the system without pausing the instrument. The system can also be configured to automatically eject a rack once all samples have been pipetted or resulted • Tube-top Sample Cup capability enables the testing of small samples with minimal handling and no need to relabel • 90 day on-board stability of reagents • Direct water feed and automated waste disposal capabilities

The IMMULITE® 2000 XPi Immunoassay System combines allergy and specialty testing with routine immunoassay testing. It features a wide-ranging menu, along with advanced software and hardware to handle nearly all the immunoassay testing challenges that laboratorians face. The IMMULITE 2000 XPi system is a continuous, random access analyzer with a throughput of up to 200 tests per hour. Its proven reliability and software simplification allows laboratories to maximize their testing capacity.

Simplified Software Enhanced software improves operator efficiency and increases walk-away time. • Intuitive user interface with touch-screen access to streamline everything from remote test ordering to sophisticated analyses of results • AutoStart capability allows you to: – Schedule daily maintenance to run automatically – Keep the instrument in a “ready-to-run state” – Run controls on demand, or at preselected times • User-configurable, auto-dilution and reflex testing function meets individual testing needs • Consumable Checklist enables preloading of the system based on the average tests run for a given day/time

Wide Menu of Esoteric and Routine Immunoassays The IMMULITE 2000 XPi menu sets the standard with a complete menu of routine and esoterics and over 300 allergens.

Disease State Assays Allergy Anemia Autoimmune Bone Metabolism Cardiovascular Diabetes Growth Hepatitis Inflammation Oncology Metabolic Function Special ID Reproductive Endocrinology Therapeutic Drug Monitoring (TDM) Thyroid Function ToRCH Veterinary Other Analytes

Influenza A & B / RSV

Strep

Additional POC

19-inch Tou

• Large displa Urinalysisat a distanc

• Fewer keyst operations

Hematology

Maxim Chemistry your IM Immunoassay Specialty

ESR

Blood Gas Expand IM capabilitie System or Coagulation

The VersaCel 2000 XPi syst capabilities a

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from the sy

• Requires on

LIS/Resources • Reduces ha walk-away

Forms

• Allows each without int


Lab Portfolio Lab Lead Form

Siemens Immulite 2000 Xpi + Test Menu

HbA1c and Glucose

Innovations to enhance your potential. Lipid Profile

Medline POC Influenza A & B / RSV

Strep

19-inch Touch-Screen Monitor

AutoStart Maintenance

Scheduled QC

• Large display for better viewing at a distance

• Automates routine maintenance on demand or at convenient times

• Run QC on demand at pre-scheduled times to minimize disruption

• Fewer keystrokes to simplify operations

Maximize productivity and improve workflow with your IMMULITE 2000 XPi Immunoassay System.

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay Specialty

ESR Expand IMMULITE 2000 XPi system capabilities and connect to VersaCell System or VersaCell X3 Solution The VersaCell® solutions connected to the IMMULITE 2000 XPi system are the perfect way to grow your testing capabilities as your needs expand: • Provides robotic front-end sample transfer to and from the system • Requires only one user interface and one LIS interface • Reduces hands-on operations for increased walk-away capacity • Allows each drawer to be accessed independently without interrupting sample processing

Maximize your workflow and productivity by adding: • An ADVIA Centaur ® XPT Immunoassay System for the most comprehensive infectious disease menu available • A Dimension® EXL™ Integrated Chemistry System for simultaneous chemistry and immunoassay processing to increase workflow efficiency • Siemens Healthineers automation and IT solutions to simplify your laboratory operations

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens Immulite 2000 Xpi + Test Menu

Lab Lead Form HbA1c and Glucose

ADVIA Centaur, Dimension, EXL, IMMULITE, VersaCell,and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84-0 siemens-healthineers.com

Maxim Labor

Specialty

ESR

IMMULITE 2000

Blood Gas siemens-health Published by Siemens Healthcare Diagnostics Inc. Laboratory Diagnostics 511 Benedict Avenue Tarrytown, NY 10591-5005 USA Phone: +1 914-631-8000

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Order No. 30-18-11502-01-76 | 06-2018 | © Siemens Healthcare Diagnostics Inc., 2018

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Lab Portfolio Tosoh AIA-900 Immunoassay Analyzer

Lab Lead Form

®

AUTOMATED ENZYME IMMUNOASSAY ANALYZER

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR

Tosoh Result Integrity • Multi-Tasking Efficiency

Blood Gas

Coagulation

TOSOH BIOSCIENCE www.tosohbioscience.us

Cardiac

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Lab Portfolio Lab Lead Form

Tosoh AIA-900 Immunoassay Analyzer

HbA1c and Glucose

Lipid Profile Medline POC

Four Configurations Provide Expansion Capabilities Features:

Influenza A & B / RSV

Strep

• 90 tests/hour throughput • First result in ~ 18 minutes

Additional POC

• Random access / Continuous processing • 90 day calibration for most assays

Urinalysis

• Simple touch screen operation • Bar-coded primary tube sampling

Hematology

• Clot detection • Automated pretreatment

Chemistry

• Automated dilution from 2 to 1000 Immunoassay

Specialty

ESR Blood Gas

AIA-900 Loader Model

AIA-900 Benchtop

AIA-900 with 9 Tray Sorter

AIA-900 with 19 Tray Sorter

Coagulation Cardiac

LIS/Resources ®

Forms


Lab Portfolio Lab Lead Form

Tosoh AIA-900 Immunoassay Analyzer

Four Configurations for Different Sizes of Labs and Workloads

AIA-900

HbA1c and Glucose

Benchtop Lipid Profile

Benchtop

• 90 tests/hour throughput • Load 10 racks on board • Load up to 5 tests/patient

Medline POC

Dimensions - W/D/H: Influenza A & B / RSV

40” x 26.18” x 30” 1016 mm x 665 mm x 762 mm Dimensions include revolving carousel

AIA-900

Loader Model

Strep

Loader Model Additional POC

• 90 tests/hour throughput • Load 10 racks on board • Load up to 5 tests/patient

Urinalysis

Dimensions - W/D/H: 35.04” x 26.18” x 49.09” 890 mm x 665 mm x 1247 mm Dimensions include analyzer/sorter stand

AIA-900

with 9 Tray Sorter • • • • •

Hematology

9 tray sorter

90 tests/hour throughput Load 9 trays (20 cups/tray) Load 10 sample racks Load 100 patient samples Increased walkaway time with loading 180 test cups

Immunoassay

Specialty

Dimensions - W/D/H:

ESR

50.79” x 26.18” x 49.09” 1290 mm x 665 mm x 1247 mm Dimensions include analyzer/sorter stand

AIA-900

with 19 Tray Sorter • • • • •

90 tests/hour throughput Load 19 trays (20 cups/tray) Maximize walkaway time with loading 380 test cups Load 10 sample racks Load 100 patient samples

Dimensions - W/D/H: 59.84” x 26.18” x 49.09” 1520 mm x 665 mm x 1247 mm Dimensions include analyzer/sorter stand

Chemistry

Blood Gas

19 tray sorter Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Tosoh AIA-900 Immunoassay Analyzer

HbA1c and Glucose

Lipid Profile Medline POC

Substrate II

B/F Probes

On-board Printer

Touch Screen Monitor

Influenza A & B / RSV

Strep

Secondary Reagents

• Types: 100 mL & 5 mL • Variable Configurations

Additional POC Urinalysis

Tips

• 2 Racks, 96 Tips • 192 Tips Total

Hematology Chemistry

Immunoassay

Sample Loader

Specialty

ESR

Load tubes for Sorter Models Blood Gas

Self-contained reagent storage Coagulation

Load cups and tubes for Loader Model

Optional 19 Tray Sorter 9 Tray Sorter also available

Cardiac

LIS/Resources ®

Forms


Lab Portfolio Lab Lead Form

Tosoh AIA-900 Immunoassay Analyzer

HbA1c and Glucose

Unit Dose Test Cup Reagent Technology

Automated Inventory Management Screens Test Cup Inventory

The AIA-PACK® test cup format works with every Tosoh AIA Automated Immunoassay System. Reagents are interchangeable, so laboratories with more than one Tosoh system can use the same reagents. Transition between systems is seamless, ensuring consistent results and efficient, economical operation for the laboratory.

Secondary Reagents

It is very easy for a lab to add a 9 or 19 tray sorter to the instrument. The reagent’s performance does not change since the analysis section of the instrument remains

Changing Reagents

unchanged.

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay Specialty

ESR Blood Gas

The AIA-900 requires minimal maintenance Daily Maintenance

Weekly

Monthly

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Tosoh AIA-900 Immunoassay Analyzer

AIA-900 Specifications

HbA1c and Glucose

Principle of measurement

Fluorescent enzyme immunoassay (FEIA) method

Processing method

Fully automated continuous random access

Processing ability

Max. 90 tests/hour (ST reagent)

Specimen quantity

10 - 125 μL

Specimen clogging detection

Pressure detection method

Measurement condition

Reaction temperature: 37°C

Reaction time

Antigen-antibody reaction time: 10 minutes, 20 minutes, 40 minutes

Specimen dilution function

Dilution ratios between 2 and 1000 can be selected for each assay

Detection method

Fluorescent measurement (top-top method)

Number of sample rack sets

Max. 10

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC

Number of samples and reagent cups Max. 100 Specimen containers

13 × 75 mm, 13 × 100 mm, 16 × 75 mm, 16 × 100 mm (O.D. × length of test tube)

Urinalysis

Dedicated sample cups Specimen barcode

Supports CODE39, CODE128, ITF, NW-7, JAN/EAN/UPC, industrial 2of5, and COOP2of5

Sample tip

Dedicated tip

Number of installed sample tips

Max. 192 tips (96 tips/rack in 2 racks)

Number of reagent sets

Max. number of reagent vials: 12, Max. number of reagent bottles: 4

External output

RS232C

Power source/consumption

100 - 240 VAC, 50/60 Hz, 300 VA

External dimensions

AIA-900 Benchtop- W/D/H: (Dimensions include revolving carousel) 40” x 26.18” x 30”; 1016 mm x 665 mm x 762 mm

Hematology Chemistry

Immunoassay

AIA-900 Loader Model - W/D/H: (Dimensions include analyzer/sorter stand) 35.04” x 26.18” x 49.09”; 890 mm x 665 mm x 1247 mm

Specialty

AIA-900 with 9 Tray Sorter - W/D/H: (Dimensions include analyzer/sorter stand) 50.79” x 26.18” x 49.09”; 1290 mm x 665 mm x 1247 mm

ESR

AIA-900 with 19 Tray Sorter - W/D/H: (Dimensions include analyzer/sorter stand) 59.84” x 26.18” x 49.09”; 1520 mm x 665 mm x 1247 mm 15 °C - 30 °C (degrees Celsius)

Humidity

40 % - 80 % R.H. (non-condensing)

EMC standard

IEC61326-1: 2005, IEC61326-2-6: 2005

TOSOH BIOSCIENCE “AIA-PACK” and “AIA” are the registered trademarks of Tosoh Corporation in United States, Canada, etc.

Blood Gas

Coagulation

Tosoh Bioscience, Inc. 6000 Shoreline Court, Suite 101 South San Francisco, CA 94080 Tel: (800) 248-6764 Fax: (650) 615-0415 www.tosohbioscience.us

Cardiac

LIS/Resources Part # 0177-90-0616

Temperature

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Lab Portfolio Diatron GEMINI

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Lipid Profile Medline POC Influenza A & B / RSV

Strep

GEMINI COMPACT MICROPLATE PROCESSOR

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

Coagulation Cardiac

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Diatron GEMINI

TUBE IN – RESULT OUT FULLY AUTOMATED MICROPLATE PROCESSOR FOR LOW THROUGHPUT APPLICATIONS • Total walk away system • Flexible time management with LIS connectivity • Modularity – open system • Ease of use, installation and maintenance • Assay performance with disposable tips • High process safety with triple pipetting control • Convenient programming of assay protocols • Proven reliability • The system is in compliance with the In-vitro diagnostic directive 98/79/EC

Reading • Absorbance reader with up to 8 different filters • Single or dual wavelength reading • End point and kinetics • Shaking Incubation • Two independently controlled incubator chambers (up to 45 °C) with shaking (20 Hz) • Three room temperature incubation chambers Washing • 2 x 8-channel washer (aspirate and dispense) • Three wash buffers • Sweep mode, soak, top and bottom wash, variable pump speed

HbA1c and Glucose

Lipid Profile Capacity and throughput • Initial loading of up to 192 samples • Continuous loading • Two deep-well plate positions for predilution and/or archiving

Medline POC Influenza A & B / RSV

Strep Ease and flexibility • Flexible scheduling of up to three plates • Graphical assay protocol editor • Combination of multiple assays on one plate • Proven software reliability • Bi-directional LIS connectivity, ideal with random access instruments • Based on established EIA software platform with more than 4,500 placements worldwide

Safety and in-process control • Pipetting pressure monitoring • Capacitive liquid level detection for optimal identification of fibrin clots and insufficient volume • Colorimetric dispense verification • Positive identification of barcoded samples and reagents

Pipetting • Liquid pipettor for disposable tips (300 μl or 1100 μl) • Flexibly programmable for single pipetting, multiple pipetting, multiple dilution steps, mixing and archiving

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

Coagulation Cardiac

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Diatron GEMINI

SPECIFICATIONS

HbA1c and Glucose

Lipid Profile READER • Photometric range: 0 to 3.0 OD • Spectral range: 400 nm to 700 nm (up to 8 filters) • Read time: < 15 sec single, < 30 sec dual • Precision: 1 % CV at 1.0 OD • Accuracy: ±0.005 OD or 2.5 % (whichever is greater) • Linearity: 0 to 2.000 OD ±1 % PIPETTOR

• Min / max. volumes: 10 μl to 300 μl with 300 μl tip 301 μl to 1000 μl with 1100 μl tip

• Precision (single dispense): < 3 % CV at 20 μl < 3 % CV at 100 μl

• Precision (multi dispense): < 10 % CV at 16 x 20 μl •

< 3 % CV at 8 x 100 μl Features: Pipetting pressure monitoring, capacitive liquid level detection, tip detection, mixing, multiple dilution steps, archiving

CAPACITY

• Sample and reagent capacity: Up to 192 samples Flexible: e.g. 144 samples + 8 reagents + 16 controls INCUBATOR • Temperature range: Up to 45 °C • Temperature uniformity: ±1.5 °C (with in-process temperature monitoring) • Shaking: 20 Hz

WASHER • Precision: 10 % CV at 300 μl • Residual volume: < 2.5 μl in U-bottom (mean) < 4 μl in flat bottom (mean)

• Wash buffer capacity: 3 wash buffers • Modes: Sweep mode, soak, top and bottom wash, variable pump speed

Medline POC Influenza A & B / RSV

DIMENSIONS

• Width x Depth x Height • 125 cm x 65 cm* x 75 cm** • 49˝ x 26˝* x 30˝** EASY INTEGRATION – NO LIMITS Additional functionality through middleware software • Easy integration: Wide range of interfaces allows consolidation of results from other instruments • Connects host: Provides smooth real time bidirectional communication between device and LIS • Connects instruments: Operates with single or multiple GEMINI installations

Strep

Additional POC Urinalysis

Hematology

* w/o Waste Bag ** Cover Closed

All values are achieved under optimal conditions and can vary depending on environmental conditions, instrument status and

Chemistry

Immunoassay Immunoassay

processing conditions.

Specialty

ESR Blood Gas

Coagulation Cardiac

We are a member of the STRATEC Group www.diatron.com I sales@diatron.com Diatron reserves the right to change any of the specifications without prior notice. Version Nr. GEMINI180605V1

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Quidel Solana®

Lipid Profile Medline POC

BD Affirm™

Influenza A & B / RSV

BD MAX

Strep

A fast, simple way to diagnose vaginitis MOLECULAR. SOLUTIONS.

The BD Affirm™ VPIII Microbial Identification Test uses DNA probe technology to accurately and quickly identify Candida species, Gardnerella vaginalis and Trichomonas vaginalis.

• Results are available in less than an hour, so treatment can begin without delay • Detects mixed infections with one vaginal swab sample

The Accurate. Sustainable. Molecular Solution.

• High sensitivity and specificity1

Additional POC

Easy as 1, 2, 3 Sample preparation: Lysis action releases microbial nucleic acid in 10 minutes

Accuracy

When information from your test relies on:

Walkaway automation: DNA probe hybridization and color development occur in just under 33 minutes

Quidel’s proprietary isothermal helicase-dependent amplification (HDA) with fluorescence detection delivers molecular results you can trust, in an actionable timeframe.

Easy-to-read results: Positive result is a clearly visible blue dot; built-in procedural controls for each sample ensure quality

Throughput

The New GeneXpert® System

Solana’s workflow is simple and flexible, capable of testing a single specimen or batching up to 12 tests at a time.

Patient Satisfaction

New Systems. Same game-changing performance.

Accurate results with DNA probe technology

Providing answers that are accurate and timely to improve patient satisfaction and build trust that they are receiving the highest quality care.

Urinalysis

Clear results: Provides objective results; built-in procedural control Detect mixed infections: One patient sample gives you results for Candida species, G. vaginalis and T. vaginalis

A better way.

Efficient: Up to six samples in less than an hour

Quidel | Molecular Diagnostics | quidel.com | 800.874.1517 | 858.552.1100

Hematology SCIEX LC-MS

Hitachi Allergy Testing

Quidel Triage

Arlington Scientific ASI Evolution

ST9800000EN00.qxp_Layout 1 2/22/18 7:23 AM Page 1

Chemistry

ACCURACY THE FIRST TIME

One test. Multiple platforms. Dependable results. Access® 2* Immunoassay System

OPTIGEN

®

Unicel® Dxl 800* Immunoassay System

Allergen-specific IgE assay US

Bring your esoteric assays in house – routinely

Quidel Triage System

Automated RPR Syphilis Testing Solution ASI Evolution Syphilis Analyzer and ASI Automated RPR Test ®

• Fully-automates CDC recommended algorithm • Diagnostic testing and blood donor screening • Enables workflow efficiencies

• Processes, analyzes, reports, archives results • Consistent, dependable and objective results

Clinical Value

Operational Value

Financial Value

• Standardized methodology • Fewer false-positives • Detect, diagnose and monitor

• Walk-a-way system • Run 190 tests/hour/analyzer • Titers up to 1:2048

• Lowest cost automated syphilis test • Minimal consumables required

Immunoassay

The ASI AUTOMATED RPR (rapid plasma reagin) Test for syphilis is a qualitative nontreponemal flocculation test for the detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis for use on the ASI Evolution® Analyzer for professional use only.

Clinically Interchangeable BNP Results Regardless of Platform1

Method comparison of BNP assay results obtained using the Triage Meter versus the Triage BNP assay for Beckman Coulter Immunoassay Systems–BNP measurements of 412 EDTA plasma samples using the Triage BNP testing platforms. A Passing-Bablock regression analysis was applied.

SCIEX DIAGNOSTICS MASS SPECTROMETERS

n

412

Range of Observations (pg/mL) Intercept (pg/mL)

5-4970

Automation Time Saving Advantage 15 Min. Hands-on time

ASI Evolution® Automated RPR Syphilis Testing

180 Min. Hands-on time

Manual RPR Syphilis Testing

900

92%

Less = Test Hands-on Time Comparison

In a study comparing the hands-on time required to run 900 tests on the ASI Evolution vs manually, it was found that the ASI Evolution required 92% less hands-on time vs the manual process. A lab tech using 30 well cards was able to perform 900 samples manually in 3 hours, 2 minutes and 3 seconds. For the ASI Evolution®, samples were placed into 5 racks (4x192 + 1x132) prior to running the samples. Total hands-on time to run 5 racks of samples was 15 minutes and 28 seconds, 1/12 the hands-on time required to perform the test manually.

–0.15

Slope

1.00

Correlation Coefficient (r)

0.950

Quidel | Rapid Diagnostics | quidel.com | 800.874.1517 | 858.552.1100

Catalog Number

ASI Evolution Analyzer

#2800-000

Catalog Number

ASI Automated RPR Test Kits

Syphilis Analyzer

#900480A

480 Tests

#2800-019

Waste System

#9004800A

4800 Tests

#2800-021

Extra Sample Racks

Catalog Number

ASI Automated RPR Controls

#905002.5A

2.5 mL Control Set

#905005A

5.0 mL Control Set

#5300-905A

EPT Diluent 20 ml

Specialty

© 2019 Arlington Scientific, Inc. All rights reserved.

In the United States: For customer service, call 1-800-654-0146 info@arlingtonscientific.com www.automatedrpr.com

For Sales Rep Use Only MK1029 Rev_032019

ESR Blood Gas

Coagulation Cardiac

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The New GeneXpert® System

Coagulation

New Systems. Same game-changing performance. Cardiac

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Cepheid GeneXpert

HbA1c and Glucose

Lipid Profile Medline POC

WE CAN’T THINK OF BETTER WORDS THAN “GAME CHANGING” Improving patient outcomes is the primary goal of any diagnostic system. But our GeneXpert® family of systems have set a new standard in workflow flexibility, 24/7 testing accuracy, and user-friendly design — delivered in an astonishingly beautiful and compact package. But we’ve done more than just repackage a good thing — we’ve improved on the fit, form, and function of the most popular molecular diagnostic platform on the market.

GeneXpert System technology is the cornerstone of our unique approach to a molecular diagnostics product suite, which allows us to offer a complete menu of tests on a single, fully scalable, consolidated workstation. The GeneXpert System is available in a one, two, four, or 16-module configuration. All have our proven GeneXpert module at their analytic heart, and use the same patented cartridge technology for every Xpert® test.

Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

Coagulation Cardiac GeneXpert I

GeneXpert II

GeneXpert IV

GeneXpert XVI

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Specialty 66 MINUTES XPERT MRSA

ESR Blood Gas

47 MINUTES

47 MINUTES

XPERT VAN A

XPERT C. DIFFICILE

Coagulation Cardiac

LIS/Resources GAME CHANGER : CEPHEID GENEXPERT SYSTEM

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GAME CHANGER : SPEED

Medline POC Influenza A & B / RSV

When it comes to speed, other molecular analyzers simply can’t compete. The GeneXpert® System returns most test results in about an hour, including sample prep! Our systems deliver results even faster than many alternative technologies, such as EIA or Immunoassay. With the GeneXpert System, labs no longer need rows of equipment and extensively trained staff to deliver molecular results. No matter which GeneXpert System you choose, Cepheid’s technology makes on-demand molecular testing available to everyone — with unprecedented speed and ease-of-use. Our patented cartridges also deliver unsurpassed accuracy across the broadest possible menu, and are virtually unlimited in the sample types they can process.

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty GeneXpert Cartridge The cornerstone of the GeneXpert testing process is Cepheid’s patented, self-contained, single use cartridge. Sample extraction, amplification and detection are all carried out within this self-contained “laboratory in a cartridge”.

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GAME CHANGER : SIZE

Medline POC Influenza A & B / RSV

With its compact design, the GeneXpert® System allows for portability in the field and can run tests just about anywhere. In fact, due to the recent World Health Organization (WHO) endorsement of our systems, we now have molecular diagnostic “centers of excellence” in some of the most remote places on earth. The decreased system footprint and consolidated testing design creates space-saving efficiency, reducing the need

for multiple testing platforms. These new systems are also designed to be stackable, for those labs where space is a particular issue. And we’ve now introduced a new configuration, the two-module GeneXpert System, to provide even more options for smaller institutions.

Strep

Additional POC Urinalysis

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Immunoassay

Specialty

ESR Blood Gas

Coagulation Cardiac

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TB Detection Going Mobile

Photographs courtesy of Michael Hoelscher, University Munich/Mbeya Medical Research Programme

Lipid Profile Medline POC Influenza A & B / RSV

Processing Unit A four-site GeneXpert System can be configured with 1, 2, 3 or 4 modules. A 16-site system can be configured with 4, 8, 12, or 16 modules. For the highest throughput applications, a GeneXpert Infinity System can scale to 80 modules. All systems can be easily upgraded with additional modules.

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty ESR Blood Gas

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GAME CHANGER : IMPACT

Medline POC Influenza A & B / RSV

The GeneXpert® System fully integrates and automates sample extraction, amplification, and detection — all in one cartridge. On-demand. Just load a biological sample and the system does the rest.

Strep

Additional POC Urinalysis

While implementing rapid MRSA surveillance testing with the GeneXpert® System, there were 138 patient care days saved and 230 more admissions, generating additional revenue of $1,150,000 during the 2007 – 2008 period.”

Hematology Chemistry

Immunoassay

Specialty

Denise Uettwiller-Geiger, Ph.D., DLM (ASCP) Director of Laboratory Services and Clinical Trials John T. Mather Memorial Hospital

ESR Blood Gas

Coagulation Cardiac

LIS/Resources 8

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GAME CHANGER : MENU

Hematology Chemistry

The simplicity of the GeneXpert System is often compared to a chemistry or hematology analyzer. Simply load the cartridge and the system does the rest. ®

The unparalleled efficiency and ease-of-use will add unseen value to your entire institution. However, the “ripple effect” of rapid, real-time, random access results goes well beyond the four walls of the laboratory — everyone in your facility benefits from getting the right result at the right time, including your patients. And all of Cepheid’s GeneXpert Systems offer complete interfacing compatibility with your data management system, enabling your clinical staff to take full advantage of the speed and accuracy of molecular diagnostics. Finally, the entire GeneXpert family is designed with LEAN principles in mind, in order to eliminate wasted time, effort, and resources at every opportunity. The systems can easily integrate into any lab to improve workload and workflow optimization.

Immunoassay

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Specifications

Medline POC OPTICS

PHYSICAL DIMENSIONS

Dye detection limit < 1 nM

GX-I Processing Unit: 4.00" w x 12.00" h x 11.70" d

Influenza A & B / RSV

GX-II Processing Unit: 6.35" w x 12.00" h x 11.70" d OPTICAL CHANNEL CHARACTERIZATION

GX-IV Processing Unit: 11.00" w x 12.00" h x 11.70" d GX-XVI Processing Unit: 22.75" w x 25.80" h x 13.25" d

Channel

Excitation

Emission

Calibrated Reporter Dyes

1

375–405

420–480

CF 1

2

450–495

510–535

FAM

POWER REQUIREMENTS

3

500–550

565–590

Alexa Fluor ® 532

Rated Voltage: 100-240 V~, 50-60 Hz

4

555–590

606–650

Texas Red®

5

630–650

665–685

Alexa Fluor 647

6

630–650

>700

CF 6

Strep

Additional POC

Rated Current GX-I: 1.5A @ 100V~, 0.75 A @ 200V~

®

REACTION SITE THERMAL CONTROLS • Solid state heater and forced-air cooling at each site

Rated Current GX-II: 1.5A @ 100V~, 0.75 A @ 200V~ Rated Current GX-IV: 1.9A @ 100V~, 0.95 A @ 200V~

GENEXPERT® DIAGNOSTIC SYSTEM U.S. PART NUMBERS*

• Reaction chamber thermistors calibrated to ± 1.0°C using National Institute of Standards and Technology (NIST)-traceable standards

GeneXpert Model GX-I Single module instrument with laptop

GXI-1-L

• Up to 16 independently-controlled reaction sites

GeneXpert Model GX-II 2 module instrument with laptop

GXII-2-L

CARTRIDGES

GeneXpert Model GX-IV 4 module Instrument with desktop

GXIV-4-D

GeneXpert Model GX-XVI 16 module instrument with desktop

GXXVI-16-D

Single-use disposable cartridges Polypropylene construction PERFORMANCE PARAMETERS Heating ramp rates (max.): 10°C/sec from 50°C to 95°C

Urinalysis

Rated Current GX-XVI: 8.24A @ 100V~, 4.12 A @ 200V~

Hematology Chemistry

Immunoassay

*For a full listing of the instrument configurations available to meet your needs visit www.cepheid.com

Specialty

Cooling ramp rates (max.): 2.5°C/sec from 95°C to 50°C

ESR

Temperature duration accuracy: ± 1.0 sec from programmed time Temperature accuracy: ± 1.0°C from 60°C to 95°C

Blood Gas

Melt curve programmable ramp rates: 0.01°C/sec to 1.0°C/sec

Coagulation CORPORATE HEADQUARTERS

EUROPEAN HEADQUARTERS

904 Caribbean Drive Sunnyvale, CA 94089 USA

Vira Solelh 81470 Maurens-Scopont France

TOLL FREE

1.888.336.2743 1.408.541.4191 FAX 1.408.541.4192

PHONE

PHONE

FAX

www.Cepheid.com

Cardiac

33.563.82.53.00 33.563.82.53.01

The purchase of this product allows the purchaser to use it with Cepheid GeneXpert assay cartridges and Cepheid GeneXpert® assay software. No general patent or other license of any kind other than this specific right of use from purchase is granted hereby. No other rights are conveyed expressly, by implication or estoppel. Furthermore, no rights for resale are conferred with the purchase of this product.

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ESR

GeneXpert I

GeneXpert II GeneXpert Xpress II

GeneXpert IV GeneXpert Xpress IV

GeneXpert XVI

The GeneXpert System

Blood Gas

®

Coagulation

Molecular diagnostics made fast, accurate, and easy. With the GeneXpert® System and the Xpert® test menu, Cepheid delivers actionable results when clinicians need them most.

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GeneXpert System: Clinical IVD Test Menu ®

Medline POC Number of Tests

Healthcare Associated Infections

Critical Infectious Diseases

Xpert® MRSA NxG

Active MRSA surveillance testing in 45 minutes*

Xpert® SA Nasal Complete

Pre-surgical testing for S. aureus and MRSA in about an hour

10

GXSACOMP-10

Xpert® MRSA/SA BC

Detection of MRSA and S. aureus in positive blood cultures in about an hour

10

GXMRSASA-BC-10

Xpert® MRSA/SA SSTI

Detection of MRSA & S. aureus skin and soft tissue infections in about an hour

10

GXMRSASA-SSTI-10

Xpert® C. difficile

Detection of Clostridium difficile in just over 30 minutes*

10 120

GXCDIFFICILE-10 GXCDIFFICILE-120

Xpert® C. difficile/Epi

Detection and differentiation of Clostridium difficile & the epidemic 027 strain in 45 minutes

10 120

GXCDIFF/EPI-10 GXCDIFF/EPI-120

Xpert® vanA

On-demand testing to assist with VRE surveillance in just over 30 minutes*

10

GXVANA-10

Xpert® Carba-R

Detection of the carbapenem-resistance genes encoding KPC, NDM, VIM, OXA-48 and IMP in 48 minutes from isolates or rectal swabs

10

GXCARBAR-10

Xpert® Norovirus

Rapid identification and differentiation of Norovirus GI and GII in less than one hour*

10

GXNOV-10

Xpert® Xpress Strep A

Rapid detection of Group A Streptococcus in as soon as 18 minutes*

10

XPRSTREPA-10

Xpert® Xpress Flu

Rapid detection of Flu A and Flu B in as soon as 20 minutes* #

10

XPRSFLU-10

Xpert® Xpress Flu/RSV

Rapid detection and differentiation of Flu A, Flu B, and RSV in as soon as 20 minutes^

10

XPRSFLU/RSV-10

Xpert® MTB/RIF

Detection of MTB and rifampin resistance mutations in less than two hours

10

GXMTB/RIF-US-10

Xpert® EV

Fast molecular diagnostic testing for enterovirus in 2.5 hours

10

GXEV-100N-10

Xpert Ebola

Detection of Ebola Zaire virus in 98 minutes

10

GXEBOLA-10

Xpert® CT/NG

Detection of Chlamydia trachomatis and Neisseria gonorrhoeae infections in 90 minutes

10 120

GXCT/NG-10 GXCT/NG-120

Xpert® TV

Detection of Trichomonas vaginalis in male and female specimens in as soon as 40 minutes*

10

GXTV-10

Xpert® GBS

Intrapartum screening for Group B streptococcus during labor/ delivery in 35 minutes*

10

GXGBS-100N-10

Xpert® GBS LB

Antepartum screening from LIM broth for Group B streptococcus in 35 minutes*

10 120

GXGBSLB-10 GXGBSLB-120

Xpert® FII & FV

Identification of genetic risk factors for thrombosis in 30 minutes

10

GXFIIFV-10

®

Women’s & Sexual Health

Oncology & Genetics

Catalog Number

10 120

GXMRSA-NXG-10 GXMRSA-NXG-120

Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty ESR Blood Gas

Coagulation

These are non-waived tests. * With EAT (Early Assay Termination), for Positive Results ^ For positive Flu only or RSV only. Reporting negatives and combined reporting in 30 minutes. # Xpert Xpress Flu in vitro diagnostic device for use in Moderately Complex or CLIA waived setting. All other tests are non-waived tests. † For Use Under an Emergency Use Authorization (EUA) Only

Cardiac

For In Vitro Diagnostic Use. CORPORATE HEADQUARTERS

EUROPEAN HEADQUARTERS

904 Caribbean Drive Sunnyvale, CA 94089 USA

Vira Solelh 81470 Maurens-Scopont France

TOLL FREE PHONE FAX

+1.888.336.2743 +1.408.541.4191 +1.408.541.4192

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MOLECULAR. SOLUTIONS.

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Additional POC

The Accurate. Sustainable. Molecular Solution.

Urinalysis

Hematology Chemistry

When information from your test relies on: Accuracy

Quidel’s proprietary isothermal helicase-dependent amplification (HDA) with fluorescence detection delivers molecular results you can trust, in an actionable timeframe.

Immunoassay

Specialty

ESR

Throughput

Solana’s workflow is simple and flexible, capable of testing a single specimen or batching up to 12 tests at a time.

Blood Gas

Coagulation

Patient Satisfaction

Providing answers that are accurate and timely to improve patient satisfaction and build trust that they are receiving the highest quality care.

Cardiac

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Solana provides critical diagnostic information for the following disease states:

Lipid Profile

Influenza A+B Results you can trust when accuracy is critical. Highly accurate molecular results in an actionable timeframe. Results you can trust for your high risk patients, on a platform built for your lab in just 45 minutes.

Medline POC

RSV + hMPV Enhance your respiratory testing with RSV and hMPV.

Human metapneumovirus is a common respiratory virus which often gets mistaken for respiratory syncytial virus when diagnosing based on empirical evidence alone. Reduce onward transmission and avoid coinfection with Solana RSV + hMPV.

Respiratory Viral Panel All the answers when you want them. Individual answers when you need them. Solana RVP detects and differentiates the common respiratory viral strains of respiratory syncytial virus, human metapneumovirus, and influenza A and B in as little as 45 minutes.

Influenza A & B / RSV

Strep

Group A Strep Group A strep testing with no culture confirmation required.

30 minutes to a confirmatory strep A diagnosis. Gold standard sensitivity with the ability to run up to 12 specimens in a single run, allowing prompt initiation of patient management and antimicrobial therapy.

Strep Complete Group A and pyogenic Group C/G with no culture confirmation required. Pyogenic group C/G strep is a significant cause of strep pharyngitis in teenagers and adults. These strains will go undetected when using a rapid antigen test. Differentiate between A and the pyogenic C/G strains in just 30 minutes. GBS Accurate results when it matters most. Obtain accurate GBS results faster than traditional GBS testing methods and help prevent transmission of GBS from mother to newborn. HSV 1+2/VZV Remove the uncertainty in your lesion diagnosis. Detect and differentiate herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus from any lesion in just 60 minutes. Trichomonas Stop compromising. Start treating. The CDC recommends testing for trichomonas using highly sensitive Nucleic Acid Amplification Tests, like Solana, to avoid the underdiagnosis and undertreatment of trichomonas infections. C. difficile Molecular testing with connectivity for easy results monitoring.

Change the way you monitor C. difficile results with Virena®. Virena provides an electronic patient de-identified data management system to monitor results on a daily basis.

Bordetella Complete Enhance your respiratory testing options in your practice with BP and BPP. Detect and differentiate Bordetella pertussis and Bordetella parapertussis in just 50 minutes. Test*

Classification

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

Sensitivity %

Specificity %

Influenza A+B

98.6/100

95.1/99.3

RSV + hMPV

95.5**/95.6**

99.9**/99.8**

GAS

98.2

97.2

Strep Complete

Pyogenes Dysgalactaie

98.8 100

98.9 99.5

GBS

LIM broth Carrot broth

100 100

95.9 96.0

HSV 1+2/VZV

Cutaneous Mucocutaneous

100/92.3/100 100/99.1/100

97.8/94.4/95.5 96.4/97.2 /98.6

Trichomonas

Swab Urine

99.2 95.0

98.7 98.2

C. difficile

93.0

99.2

Bordetella Complete

100

99.7

ESR Blood Gas

Coagulation Cardiac

SL2018 | SS2027805EN00 (07/18)

*Refer to each products Package Insert for additional performance claims. **Represents PPA and NPA values.

Additional POC

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BD Affirm

HbA1c and Glucose

A fast, simple way to diagnose vaginitis

Lipid Profile Medline POC

The BD Affirm™ VPIII Microbial Identification Test uses DNA probe technology to accurately and quickly identify Candida species, Gardnerella vaginalis and Trichomonas vaginalis.

• Results are available in less than an hour, so treatment can begin without delay • Detects mixed infections with one vaginal swab sample • High sensitivity and specificity1

Influenza A & B / RSV

Strep

Additional POC Urinalysis

Easy as 1, 2, 3 Sample preparation: Lysis action releases microbial nucleic acid in 10 minutes

Hematology

Walkaway automation: DNA probe hybridization and color development occur in just under 33 minutes

Chemistry

Easy-to-read results: Positive result is a clearly visible blue dot; built-in procedural controls for each sample ensure quality

Immunoassay

Specialty

ESR Blood Gas

Accurate results with DNA probe technology Clear results: Provides objective results; built-in procedural control Detect mixed infections: One patient sample gives you results for Candida species, G. vaginalis and T. vaginalis Efficient: Up to six samples in less than an hour

Coagulation Cardiac

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BD Affirm

HbA1c and Glucose

Vaginal infections: The power of DNA technology for better patient care

Lipid Profile Medline POC

The BD Affirm™ VPIII System • No specialized facilities required: Unlike other molecular tests, such as PCR-based tests, BD Affirm does not require specialized facilities 1

Influenza A & B / RSV

• No specialized personnel needed: Easy to learn, easy to use

Additional POC

Strep

• Efficient use of staff time: Hands-on time is less than 2 minutes

Urinalysis

• Quick turnaround time: Up to six results in less than an hour

Hematology BD Affirm performance data1

Chemistry

SENSITIVITY

SPECIFICITY

ACCURACY

G. vaginalis*

98.3%

100%

98.4%

T. vaginalis**

92.8%

99.9%

98.9%

Candida species*

82.3%

98.4%

95.2%

*Compared to culture (symptomatic patients) **Compared to wet mount (symptomatic and asymptomatic patients)

Call 1-800-999-4951 ext. 3597 to get started with BD Affirm today Or email: BD_Womenshealth@bd.com

Immunoassay

Specialty

ESR Blood Gas

Coagulation

INTENDED USE: The Affirm™ VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species, Gardnerella vaginalis and Trichomonas vaginalis nucleic acid in vaginal fluid specimens from patients with symptoms of vaginitis/vaginosis.1 1 BD Affirm™ VPIII Microbial Identification Test [package insert]. Sparks, MD: BD Diagnostics; 2010. BD, BD Logo and all other trademarks are property of Becton, Dickinson and Company. ©2010 BD 0-223325 December 2010 Printed in USA

Cardiac BD Diagnostics Women’s Health and Cancer 7 Loveton Circle Sparks, MD 21152-0999 800.638.8663 www.bd.com/ds

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Lab Portfolio BD MAX

Lab Lead Form HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio BD MAX

Lab Lead Form HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio BD MAX

Lab Lead Form HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Sciex LC-MS

Lab Lead Form HbA1c and Glucose

ACCURACY THE FIRST TIME

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Bring your esoteric assays in house – routinely

Immunoassay

Specialty ESR

SCIEX DIAGNOSTICS MASS SPECTROMETERS

Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Sciex LC-MS

Lab Lead Form HbA1c and Glucose

Lipid Profile

Reliabilit Medline POC confiden Your routine diagnostic testing lab requires accurate trace level quantitation of multiple

With an unmatched Influenza A & Boffer / RSVan a systems*

Faster return on investmen

Strep Lower running costs and in

technology add up to signi

compounds in physiological matrices. We have 30 years of experience delivering high-

on investment.

Additional POC

The right answer, the first

High sensitivity, low detect to better data and greater Urinalysis Faster time to results

performance LC/MS/MS systems, software,

LC/MS/MS significantly red Hematology

run times and dramatically

quality results in minutes, n

service and support. Now SCIEX Diagnostics is bringing this expertise to diagnostics laboratories: we are the partner you can trust to help you meet your objectives. Save time, cut costs, and support physicians with greater confidence and better results.

Chemistry

Immunoassay

Specialty ESR Blood Gas

Coagulation Cardiac

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Sciex LC-MS

HbA1c and Glucose

Lipid Profile

Reliability, reproducibility, and confidence in your data

Medline POC

With an unmatched heritage of technological innovation and dependability, the SCIEX Diagnostics systems* offer an attractive blend of performance, throughput, and value. Faster return on investment

More compounds per analysis, more analysis per day

Lower running costs and increased throughput of LC/MS/MS

Identify low-level concentrations of compounds in more samples

technology add up to significant savings and a faster return

and with greater accuracy. SCIEX Diagnostics LC/MS/MS

on investment.

technology simplifies sample preparation and dramatically increases throughput. So you can increase the type and variety of tests

The right answer, the first time High sensitivity, low detection limits, and high specificity lead to better data and greater confidence. Faster time to results LC/MS/MS significantly reduces sample preparation and analytical run times and dramatically increases throughput to give highquality results in minutes, not hours.

you can perform with a single instrument, and make better

Influenza A & B / RSV

Strep

Additional POC

decisions faster.

Urinalysis

Maximum instrument uptime Run thousands of samples with minimal downtime. SCIEX Diagnostics LC/MS/MS supports you with rugged, robust instrumentation and worldwide service and support.

Hematology

*Not available for in vitro diagnostic use in all countries. Check with your sales representative at www.sciexdiagnostics.com/contact-us

Chemistry

Immunoassay

Specialty ESR Blood Gas

Coagulation Cardiac

LIS/Resources IVD-MKT-03-1540-A

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Sciex LC-MS

HbA1c and Glucose

Performance that’s anything but entry level SCIEX Diagnostics LC/MS/MS systems are affordable benchtop platforms that give you a unique level of performance and application versatility. Multi-compound analysis The ability to quantitate multiple compounds in a single run provides more results in fewer experiments.

Like all our industry-leading

minimum maintenance requirements, the systems are designed to

feature the Turbo V™ ion so

make it easy for you to get the answers you need, and respond to

for Strep best-in-class reliability,

High throughput

With simplified sample preparation requirements you can perform multiple types of assays on a single platform, and analyze clinical compounds from various types of matrices. Grow the menu assay as your lab and testing requirements grow

Clinical laboratories challenging applica Influenza A & B / RSV

method development to quick, simple ion source changes and

new testing challenges.

Versatility

High up maximu Medline POC Lipid Profile

The compact benchtop systems are powerful, easy-to-use tools

routine clinical testing.

Sensitivity and confidence

Additional POC

The Turbo V source efficien

that are rugged enough for continuous high-throughput operation.

eliminates cross-contamina

With intuitive software and a full complement of automation

high-sensitivity quantitatio

features, they fit seamlessly into the workflows of any clinical

Urinalysis

diagnostic laboratory.

Maximum uptime

The systems are sensitive and specific for the analytes most

The proprietary Curtain Ga

Hematology maintenance and ensures m

commonly requested in screening programs and routine testing in a number of key areas of clinical diagnostics. From automated

interface region and mass

Chemistry

Immunoassay

Specialty ESR Blood Gas

Coagulation Time, min Chromatogram showing the analysis of 14 compounds in a single run.

Cardiac

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Lab Portfolio Sciex LC-MS

Lab Lead Form HbA1c and Glucose

High uptime, high reproducibility, maximum productivity

Lipid Profile Medline POC

Clinical laboratories expect maximum uptime and systems that can easily handle the most challenging applications.

Influenza A & B / RSV

Like all our industry-leading mass spec systems, the platforms feature the Turbo V™ ion source and Curtain Gas™ interface

Strep

for best-in-class reliability, sensitivity and reproducibility in routine clinical testing. Sensitivity and confidence in results

Additional POC

The Turbo V source efficiently ionizes compounds and virtually eliminates cross-contamination, even with large sample loads, for high-sensitivity quantitation over a wide range of flow rates.

Urinalysis

Maximum uptime The proprietary Curtain Gas interface reduces the need for routine

Hematology

maintenance and ensures maximum productivity by protecting the interface region and mass spec analyzer contamination.

Chemistry

Immunoassay

Specialty ESR Blood Gas

Coagulation Cardiac

LIS/Resources IVD-MKT-03-1540-A

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Sciex LC-MS

HbA1c and Glucose

Lipid Profile

Two SCIEX Diagnostics platforms to match your detection needs Both systems provide you with highly reliable, accurate results from every quantitative analysis – all at an excellent value.

Powerfu Medline POC workflo

Optional QTRAP® technology brings an additional level of versatility with unmatched simultaneous quantitative and qualitative analysis.

Expert results – eve Influenza A & B / RSV Analyst® MD Software

Simultaneous qualitative and quantitative analysis Unique to SCIEX Diagnostics mass spec platforms, QTRAP

®

Strep

Powerful software too and reporting

system technology provides the ability to identify and quantitate The Triple Quad 4500MD system ™

trace level compounds from complex samples in a single run.

offers best-in-class selectivity,

This results in enhanced capabilities for screening programs

• Configure, tune, acqui Additional POC

high confidence – even

sensitivity and throughput, while

enabling simultaneous sensitive quantitation and library searching

maintaining the highest standards of accuracy.

workflows. Additionally QTRAP® technology provides enhanced

Automatically create fu

compounds, analyze a Urinalysis

quantitative selectivity when high background or challenging co-eluting interferences make standard quantitation difficult.

Hematology

Response Peak Area (counts)

8.00E+06

6.00E+06 5.00E+06 4.00E+06 3.00E+06 2.00E+06 1.00E+06 0.00E+00

1.90 1.80 1.70 1.60 1.50 1.40 1.30 Response 3.5% CV 1.20 1.10 1.00 ISTD Corrected 2.9% CV 0.90 0.80 0.70 ISTD Corrected 1.6% CV 0.60 0.50 0.40 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 Response 2.1% CV

7.00E+06

0

Internal Standard Area Ratio

Robustness test in plasma: 1500 injections

Chemistry ®

Cliquid MD Software •

The API 3200MD™ system provides a powerful combination of performance, throughput and value for diagnostic testing.

operation

Immunoassay •

training needs

requirements grow

Reproducibility of results for example analytes in human plasma shows the stability of the 4500MD system for consistent measurement day after day, week after week, month after month.

Recommended for

3200MD Labs performing standard assays that do not require the lowest level of quantitation

4500MD Labs needing higher sensitivity and higher throughput

Why this is important

SCIEX Diagnostics can help you find the instrument that best suits your needs and budget.

MRM mode sensitivity

1x

10x

QTRAP sensitivity*

1x

50-100x

700 msec

50 msec

Faster polarity switching allows you to monitor positive and negative ions in a single method. No need to perform 2 analyses on each sample.

5 msec

1 msec

Smaller MRM dwell times allow you to monitor more analytes in a single method. You can further improve your throughput by switching to fast UHPLC methods.

Triple quadrupole scan speed

24,000 Da/sec

12,000 Da/sec

QTRAP scan speed*

4,000 Da/sec

20,000 Da/sec

Polarity switching time Minimum MRM dwell time

Step-by-step workflow

• Optimized assay menu Specialty

Injection Number

Specifications

Intuitive user interface

Higher sensitivity means less sample preparation may be required, and enables the detection of trace levels of compounds in biological matrices.

Compatible with LIS/LI

Compatible with barco

ESR

Blood Gas

Coagulation Cardiac

Faster scanning speeds allow you to acquire more information about your sample, in each run. You can further improve your throughput by switching to fast UHPLC methods.

*Only applicable to the QTRAP 3200MD and QTRAP 4500MD systems.

LIS/Resources

The 4500MD system offers 10x greater sensitivity, up to 5x faster data acquisition in MRM mode, and 14x faster polarity switching. With the QTRAP option, each system provides additional detection modes, with the 4500MD system scanning 5x faster, and providing 50-100x greater sensitivity than the 3200MD system.

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Sciex LC-MS

HbA1c and Glucose

Lipid Profile

Powerful, easy-to use, workflow-driven software

Medline POC

Expert results – even for non mass spec experts.

Influenza A & B / RSV

Analyst® MD Software •

Strep

Powerful software tool for instrument control, data analysis and reporting

Additional POC

Configure, tune, acquire data, explore, and quantitate with high confidence – even when working with complex matrices

Automatically create fully optimized methods for multiple

Urinalysis

compounds, analyze and compare analytical results

Analyst® MD Software – Powerful software tool for instrument control, data analysis

Hematology

and reporting.

Chemistry

Cliquid® MD Software •

Intuitive user interface for simplified, routine mass spec operation

Immunoassay

Step-by-step workflow-driven, for easy operation and reduced training needs

Specialty

Optimized assay menu you can grow as your lab and testing requirements grow

Compatible with LIS/LIMS

Compatible with barcode reading workflows

ESR Blood Gas Cliquid MD Software step-by-step user interface. From assay menu selection to customized report.

Coagulation Cardiac

LIS/Resources IVD-MKT-03-1540-A

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Sciex LC-MS

HbA1c and Glucose

Your success is our success

Lipid Profile

We take it personally

Medline POC

As a SCIEX Diagnostics customer, you have access to a world-class customer support organization. Wherever you are, we’re there with you as a trusted partner to answer questions, provide solutions,

Influenza A & B / RSV

and maximize lab productivity. Our customer support organization has access to the latest product updates, software revisions,

Strep

methods and repair procedures to make sure that you stay on top of your game.

Additional POC

When you have questions, we have answers. For more information on the SCIEX Diagnostics Systems, visit

Urinalysis

www.sciexdiagnostics/products/instruments

Hematology Chemistry

Immunoassay

Specialty ESR Blood Gas

Coagulation For In Vitro Diagnostic Use. Not available in all countries. Check www.sciexdiagnostics.com/instruments © 2014 AB SCIEX. SCIEX is part of AB SCIEX. The trademarks mentioned herein are the property of AB Sciex Pte. Ltd. or their respective owners. AB SCIEX™ is being used under license. 6900113-01 7/2014 IVD-MKT-03-1540-A

Headquarters 500 Old Connecticut Path | Framingham, MA 01701 USA Phone 508-383-7700 www.sciexdiagnostics.com

International Sales For our office locations please call the division headquarters or refer to our website at www.sciexdiagnostics.com/contact-us

Cardiac

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Lab Portfolio Lab Lead Form

Hitachi Allergy Testing

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC

OPTIGEN

®

Urinalysis

Allergen-specific IgE assay

Hematology

US

Chemistry

Immunoassay

Specialty ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Hitachi Allergy Testing

HbA1c and Glucose

OPTIGEN®

Lipid Profile

Test up to 36 allergens with only 0.6mL patient sample

Medline POC

• High screening capability, high diagnostic value • Small sample volume, ideal for pediatric testing

Influenza A & B / RSV

• Trusted data provided to doctors since 1991 • Semi-automated machine available to reduce hands-on time

OPTIGEN® Kit Components

Strep

Additional POC

OPTIGEN® Pette

Urinalysis 36 Discrete Allergen Wells

Hematology Chemistry

Immunoassay

All reactions happen inside Pette

Specialty ESR

Comparison with our conventional CLA-Pette Method Serum volume

Assay time

1.5ml 0.6ml

OPTIGEN

CLA-Pette

24H

OPTIGEN

®

CLA-Pette

Coagulation

Not Available

Available

6H ®

Semi-automated machine

Blood Gas

OPTIGEN

®

X

Cardiac

LIS/Resources

CLA-Pette

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Hitachi Allergy Testing

HbA1c and Glucose

OPTIGEN® ASSAY OVERVIEW

Lipid Profile

OPTIGEN® Assay Options

Medline POC

Semi-automated assay with AP720S™

Manual Assay

80% less hands on time

Minimal investment

Easy-daily maintenance

6 simple steps

20 sample capacity per run

Ideal for smaller labs

Influenza A & B / RSV

Strep

Additional POC Urinalysis

OPTIGEN® Measurement

Hematology Chemistry

The lights emmitted from Pette are measured in the CLA-1 Luminometer

Immunoassay

Specialty CLA-1™ Luminometer

Size: 12.5 (W) x 17.0 (D) x 9.0 (H) inches Weight: 18.5 pounds

OPTIGEN® Results: CLA Class Feedback CLA Class

Level of Antibodies

• Very High

4 High

3

Moderate

2 1

Low

0

Not Detectable

ESR Blood Gas

CLA Class values of 1 or above represent progressively increasing concentrations of allergen-specific antibodies.

Coagulation

CLA Class-0 represents an absence of or nondetectable levels of allergen-specific antibodies.

Cardiac

CLA Class has been used for allergy diagnostics in USA for more than 25 years.

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Hitachi Allergy Testing

HbA1c and Glucose

AP720S™ SEMI-AUTOMATED INSTRUMENT OVERVIEW

OPTIGEN®

Lipid Profile Medline POC

1 7

Pre-Wash

Pettes are ready to be read in CLA-1™ Luminometer

Influenza A & B / RSV

2

Draw Patient Serum

Strep

Additional POC 10 min Incubation

10min

2H

80% of the process is automated

6

Draw Photoreagent

5

Urinalysis

AP720S™ is FDA-cleared Size: 15.0 (W) x 15.4 (D) x 19.9 (H) inches Weight: approx 66.1 pounds

Hematology

3

The semi-automated design simplifies the OPTIGEN® assay and reduces hands-on time for lab personnel.

Wash

2 hr Incubation

2 hr Incubation

2H

Wash

Chemistry

Immunoassay

4

Specialty Draw IgE Antibody

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Hitachi Allergy Testing

HbA1c and Glucose

OPTIGEN® US Inhalant 36

Wide range of inhalant allergens selected to provide comprehensive screening across the United States TREES

WEEDS

GRASSES

DANDERS

Maple Box Elder

Lamb’s Quarters

Perrenial Rye

Cat

Black Walnut

Russian Thistle

Sweet Vernal

Dog

American Sycamore

Mugwort

Timothy Grass

Eastern Cottonwood

English Plantain

American Beech

Sheep Sorrel

White Birch

Ragweed Mix I

Ash

Nettle

White Mulberry

Pigweed

White Elm

Cocklebur

Mountain Cedar

Marshelder, Rough

MOLDS

Lipid Profile Medline POC Influenza A & B / RSV

Strep INSECT

Additional POC Alternaria

Cockroach Mix

Aspergillus Cladosporium

Urinalysis DUST MITES

Penicillium Mite Farinae

Black Alder

Hematology

Mite Pteronyssinus

Olive Pollen

Chemistry

Mesquite Acacia

Immunoassay

OPTIGEN US Food 20 ®

20 Allergen panel designed to test for common food allergy

MEAT

FRUIT

LEGUMES

DAIRY

Chicken

Apple

Pea

Cheddar Cheese

Pork

Orange

Soybean

Milk

Banana

Peanut

SEAFOOD Codfish

EGG

Strawberry GRAINS VEGETABLES

Carrot Garlic

Wheat

ESR Blood Gas

Coagulation

Egg White

Rice, White Potato

Specialty

YEAST Baker’s Yeast

Cardiac

LIS/Resources

Onion

Forms


Lab Portfolio Lab Lead Form

Hitachi Allergy Testing

HbA1c and Glucose

OPTIGEN® US Mix 36

Combination of food and inhalant allergens selected to provide comprehensive screening with limited patient volume Inhalant

Food

TREES

MOLDS

MEAT

GRAINS

Maple Box Elder

Alternaria

Chicken

White Rice

White Birch

Aspergillus

Pork

Wheat

Ash

Cladosporium

Eastern Cottonwood

Penicillium

SEAFOOD

LEGUMES

Codfish

Soybean

American Beech Black Walnut Elm, White Mountain Cedar

DANDERS

Peanut

Cat

VEGETABLES

Dog

Onion

WEEDS

INSECT

YEAST

Russian Thistle

Cockroach Mix

Brewer’s Yeast

Mugwort Sheep Sorrel

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC

DAIRY Cheddar Cheese

Urinalysis

Milk

Hematology EGG

DUST MITES

Egg White

Ragweed Mix I

Mite Farinae

Pigweed

Mite Pteronyssinus

Chemistry

Immunoassay

GRASSES Perrenial Rye

Specialty

Timothy Grass

Ordering Information

ESR

Product

Part Number

Quantity

OPTIGEN® US Inhalant 36

85063

20 Tests

OPTIGEN® US Food 20

85064

20 Tests

OPTIGEN® US Mix 36

85065

20 Tests

CLA-1™ Luminometer

90015

1

AP720S™

90051

1

OPTIGEN® Control Reagent

80109

Positive (4 – 6 Tests), Negative (4 – 6 Tests)

Blood Gas

Coagulation Cardiac

LIS/Resources Contact Information:

© 2017 by Hitachi Chemical Diagnostics, Inc. All rights reserved.

650-961-5501 | 800-233-6278 www.hcdiagnostics.com

630 Clyde Court, Mountain View, CA 94043-2239 Doc No. 0988 Rev 00

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Lab Portfolio ST9800000EN00.qxp_Layout 1 Quidel Triage

Quidel Triage BNP ALR98000XR | 25ea/bx L20.32.31.15.68 83880QW $39.26

2/22/18 7:23 AM Page 1

Placement Agreement

Lab Lead Form HbA1c and Glucose

Lipid Profile

One test. Multiple platforms. Dependable results. Access® 2* Immunoassay System

Medline POC Influenza A & B / RSV

Strep

Additional POC Unicel® Dxl 800* Immunoassay System

Urinalysis

Hematology Chemistry

Quidel Triage System

Immunoassay

Clinically Interchangeable BNP Results Regardless of Platform1 n

Method comparison of BNP assay results obtained using the Triage Meter versus the Triage BNP assay for Beckman Coulter Immunoassay Systems–BNP measurements of 412 EDTA plasma samples using the Triage BNP testing platforms. A Passing-Bablock regression analysis was applied.

412

Range of Observations (pg/mL)

Specialty ESR Blood Gas

5-4970

Intercept (pg/mL)

–0.15

Slope

1.00

Correlation Coefficient (r)

0.950

Coagulation Cardiac

LIS/Resources Quidel | Rapid Diagnostics | quidel.com | 800.874.1517 | 858.552.1100

Forms


Lab Portfolio

Quidel Triage BNP ALR98000XR | 25ea/bx L20.32.31.15.68 83880QW $39.26

Placement Agreement

Quidel Triage ST9800000EN00.qxp_Layout 1 2/22/18 7:23 AM Page 2

Lab Lead Form HbA1c and Glucose

Why Triage BNP? B-type natriuretic peptide (BNP) is a naturally secreted hormone released primarily from cardiac

Lipid Profile

myocytes in response to ventricular volume expansion and pressure overload.

1

Add whole blood sample to Triage

2

Insert test panel into Triage Meter.

BNP Test using transfer pipette included in each kit.

3

Medline POC

Read results on screen, or press “Print” for a hard copy. Complete in approximately 15 minutes.

Influenza A & B / RSV

Strep

Additional POC Urinalysis

Test results are available in approximately 15 minutes (just 2 minutes of hands-on time).

Triage BNP Test indications

BNP is an excellent hormonal marker of ventricular systolic and diastolic dysfunction.2

To aid in the diagnosis of heart failure

When used in conjunction with other clinical information, BNP levels may help risk stratify ACS patients for hospital admission or direct ED discharge.3

To risk stratify patients with acute coronary syndromes

BNP levels at the time of admission are powerful predictors of outcomes in predicting death and rehospitalization of heart failure patients.4 BNP levels have been shown to reduce time to adequate therapy, the need for hospitalization and intensive care admission, length of stay, and the mean total cost of treatment.5 CLIA waived for whole blood.

To assess the severity of heart failure To risk stratify patients with heart failure

How accurate is the Triage BNP Test The Triage BNP Test has 98 percent specificity using a 100 pg/mL cutoff.6 In initial studies, the Triage BNP Test provided 98 percent diagnostic accuracy versus all other clinical findings in patients with or without disease history and corrected 96 percent of misdiagnoses of patients with suspected heart failure.7

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

Access® and Unicel® are trademarks of Beckman Coulter Inc. 1 Triage BNP Panel [product insert]. San Diego, CA: Alere Inc.; 2016. 2 Wilkins MR, Redondo J, Brown LA. The natriuretic-peptide family. Lancet. 1997;349(9061): 1307-1310. 3 Maisel A, Mueller C, Adams K Jr, et al. State of the art: using natriuretic peptide levels in clinical practice. Eur J Heart Fail. 2008;10(9):824-839. 4 Fonarow GC, Peacock WF, Phillips CO, Givertz MM, Lopatin M, ADHERE Scientific Advisory Committee and Investigators. Admission B-type natriuretic peptide levels and in-hospital mortality in acute decompensated heart failure. J Am Coll Cardiol. 2007;49(19):1943-1950. 5 Mueller C, Scholer A, Laule-Kilian K, et al. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004;350(7):647-654. 6 Triage BNP [package insert]. San Diego, CA: Alere, Inc.; 2015. 7 Dao Q, Krishnaswamy P, Kazanegra R, et al. Utility of B-type natriuretic peptide in the diagnosis of congestive heart failure in an urgent-care setting. J Am Coll Cardiol. 2001;37(2):379-385.

Triage BNP Test – 15 Test Kit: Catalog #98010XR Triage BNP Test – 25 Test Kit: Catalog #98000XR Triage BNP Control 1 – 5 x 0.25 mL Vials: Catalog #98013XR Triage BNP Control 2 – 5 x 0.25 mL Vials: Catalog #98014XR Triage BNP Calibration Verification – 5 x 5 Levels: Catalog #98015XR

Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems

SL2702 | ST98000000EN00 (02/18)

Triage BNP Reagent Packs – 2 x 50 Tests: Catalog #98200 Triage BNP QC Controls – 2 x 3 Levels: Catalog #98201 Triage BNP Calibrators – 1 x 6 Levels: Catalog #98202

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Arlington Scientific ASI Evolution

Lab Lead Form HbA1c and Glucose

Automated RPR Syphilis Testing Solution

Lipid Profile Medline POC Influenza A & B / RSV

ASI Evolution Syphilis Analyzer and ASI Automated RPR Test

Strep

®

• Fully-automates CDC recommended algorithm • Diagnostic testing and blood donor screening • Enables workflow efficiencies

• Processes, analyzes, reports, archives results • Consistent, dependable and objective results

Additional POC Urinalysis

Hematology

Clinical Value

Operational Value

Financial Value

• Standardized methodology • Fewer false-positives • Detect, diagnose and monitor

• Walk-a-way system • Run 190 tests/hour/analyzer • Titers up to 1:2048

• Lowest cost automated syphilis test • Minimal consumables required

The ASI AUTOMATED RPR (rapid plasma reagin) Test for syphilis is a qualitative nontreponemal flocculation test for the detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis for

Chemistry

Immunoassay

use on the ASI Evolution® Analyzer for professional use only.

Specialty

Automation Time Saving Advantage 15 Min. Hands-on time

ASI Evolution® Automated RPR Syphilis Testing

180 Min. Hands-on time

Manual RPR Syphilis Testing

900

92%

Less = Test Hands-on Time Comparison

In a study comparing the hands-on time required to run 900 tests on the ASI Evolution vs manually, it was found that the ASI Evolution required 92% less hands-on time vs the manual process. A lab tech using 30 well cards was able to perform 900 samples manually in 3 hours, 2 minutes and 3 seconds. For the ASI Evolution®, samples were placed into 5 racks (4x192 + 1x132) prior to running the samples. Total hands-on time to run 5 racks of samples was 15 minutes and 28 seconds, 1/12 the hands-on time required to perform the test manually.

ESR Blood Gas

Coagulation Catalog Number

ASI Evolution Analyzer

#2800-000

Catalog Number

ASI Automated RPR Test Kits

Syphilis Analyzer

#900480A

480 Tests

#2800-019

Waste System

#9004800A

4800 Tests

#2800-021

Extra Sample Racks

Catalog Number

ASI Automated RPR Controls

#905002.5A

2.5 mL Control Set

#905005A

5.0 mL Control Set

#5300-905A

EPT Diluent 20 ml

LIS/Resources

© 2019 Arlington Scientific, Inc. All rights reserved.

In the United States: For customer service, call 1-800-654-0146 info@arlingtonscientific.com www.automatedrpr.com

Cardiac

For Sales Rep Use Only MK1029 Rev_032019

Forms


Lab Portfolio Lab Lead Form

Arlington Scientific ASI Evolution

Why Nontreponemal?

HbA1c and Glucose

Better Science, Better Technology, Better Efficiency, Better Outcomes, Better Medicine! The ASI Evolution® is the world’s first and only fully-automated system for nontreponemal RPR Syphilis testing for diagnostic testing and blood donor screening. Simply load your reagents and samples, then walk-away. The ASI Evolution automates the processing, analysis, reporting and archival of results for RPR screens.

Lipid Profile

Advantages of Nontreponemal RPR Testing

Medline POC

“ The CDC continues to recommend the traditional screening algorithm using a nontreponemal test (e.g., RPR or VDRL), with reactive nontreponemal tests confirmed by treponemal testing.” Gail Bolan, MD; Director, Division of STD Prevention; National Center For HIV/AIDs, Viral Hepatitis, STD, and TB Prevention

CDC Recommended Screening

Competitive Matrix Trep Can monitor response to therapy Lowest cost per result Can provide titers of sample Can be automated for high throughput

P

Earliest detection of infection method Recommended for prenatal screening*

Nontrep

RPR

P P P P P P

Reverse Sequence Screening (Treponemal)

RPR -

RPR + TP-PA

RPR +

TP-PA +

TP-PA -

Syphilis

Syphilis unlikely

Syphilis (past or present)

14 DAY DIFFERENCE

RECONFIRM

Nontreponemal Test Day since 1st Bleed

Urinalysis

RPR TP-PA

https://www.aafp.org/afp/2010/0115/od1.html#afp20100115od1-b3

Hematology

TP-PA +

TP-PA -

Syphilis (past or present)

Syphilis unlikely

Chemistry

Treponemal Test Treponema

PK TP

Serodia

Trinity Biotech

ASI RPR

BD RPR

NT EIA

Syphilis

Syphilis

TPPA Syp

Syphilis IgG

Syphilis IgM

NEG

NEG

NEG

NEG

NEG

NEG

NEG

NEG

Day 0

Additional POC

Quantitative RPR

*American Academy of Pediatrics, American College of Obstetricians and Gynecologists, and March of Dimes Birth Defects Foundation. Guidelines for Perinatal Care. 6th ed. Elk Grove Village, Ill.: American Academy of Pediatrics; 2008.

A 2015 CDC study determined that nontreponemal tests can detect infection up to 14 days earlier than treponemal tests.

EIA/CIA -

EIA/CIA +

CONFIRM

or other trep test

Strep

EIA or CIA

SCREEN

(Nontreponemal)

Influenza A & B / RSV

Day 5

NEG

NEG

NEG

NEG

NEG

NEG

NEG

NEG

Day 10

NEG

NEG

NEG

NEG

NEG

NEG

NEG

NEG

Day 13

NEG

NEG

NEG

NEG

NEG

NEG

NEG

NEG

Day 31

POS

POS

NEG

NEG

NEG

NEG

NEG

NEG

Day 45

POS

POS

POS

POS

POS

POS

IND

POS

Day 48

POS

POS

POS

POS

POS

POS

IND

POS

Day 52

POS

POS

POS

POS

POS

POS

IND

POS

Day 59

POS

POS

POS

POS

POS

POS

POS

POS

NEG = Negative, POS = Positive, IND = Indeterminate, Syphilis Seroconversion panel PSS901

Immunoassay

Specialty

ESR Blood Gas

Courtesy of Centers for Disease Control and Prevention

Coagulation

IDEAL CUSTOMER

DIAGNOSTIC CUSTOMER TYPES

TYPES OF SYPHILIS TESTING

500 +

- IDN’s and Hospital labs (55% total test volume*) - Reference Labs, Independent Labs (32% total test volume*) - Physcision labs - Public Health Labs - Military - University Health Centers - Others

- Manual RPR - Treponemal Method - Customers that utilize reference labs

DIAGNOSTIC MARKET

Syphilis Tests Per Week

*www.labflorida.com/blog/ lab-testing/types-labs/

ADVANTAGE TO CUSTOMER

=

- Automates CDC recommended Algorithm - Time savings, reduced hands on time - More efficient workflow - Lowest cost automated syphilis testing method - Titers up to 1:2048

Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

ESR ELITechGroup Excyte® ESR Analyzers CLINICAL SYSTEMS

Lipid Profile Medline POC

Polymedco Sedimat 15® Plus ESR Sedimat 15® Plus

Polymedco Sediten® ESR

Alcor iSED ESR

Automated ESR Reader

Strep

A U T O M AT E D E S R A N A LY Z E R 15 minute, automated ESR reader Random access capability 8 position reader Small footprint Bar code reader LIS compatible

Ordering Information

Printer available

Description

Catalog Number

Sediten Automated Reader Sedimix ESR Tube Mixer Venoplast Vacuum ESR Tubes with Diluent, 2 x 100 Venoplast Vacuum ESR Tubes with Diluent, 10 x 100 Venoplast ESR Tubes with Diluent, 2 x 100 Venoplast ESR Tubes with Diluent, 10 x 100 Venoplast ESR Tubes without Diluent, 2 x 100 Venoplast ESR Tubes without Diluent, 10 x 100 Patient Identifier Tags for Sediten Tubes, 1000 per pack Sed-Chek 2 Control Bi-Level Normal Abnormal

ESR

Erythrocyte Sedimentation Rate

Influenza A & B / RSV

261091 266191 265277 265177 261277 261177 261270 261170 180160

Additional POC

ESR-2CT ESR-2CTN ESR-2CTA

. . . For the better.

Times have changed ... Polymedco is a comprehensive diagnostics manufacturer, marketing, and distribution company with complete support departments, including customer service, technical service, and reimbursement.

P

10 minute ESR System

THE PERFECT ESR SYSTEM

POLYMEDCO, Inc.

510 Furnace Dock Road Cortlandt Manor, NY 10567 Phone: 800-431-2123 914-739-5400 Customer Service / Ordering Department Fax: 914-739-5890 Reimbursement Support Hotline: Extension 285 www.polymedco.com info@polymedco.com

Sediten

CLINICAL SYSTEMS

Urinalysis

. . . Your Innovative Partner Since 1980 . . .  Copyright August 2011 Polymedco, Inc.

PN 80224-01

Sediten, Sedimix, and Venoplast are Registered Trademarks of LP ITALIANA, SPA Sed-Chek is a Registered Trademark of Polymedco, Inc.

Hematology Alcor miniiSED ESR

Streck CUBE 30 Touch

Streck MINI-CUBE

ANALYSIS \ Sed-Rate

MINI-CUBE

An automated instrument for high-volume erythrocyte sedmentation rate testing in EDTA tubes.

An automated instrument for high-volume erythrocyte sedmentation rate testing in EDTA tubes.

• 94% correlation to Modified Westergren Method • Compatible with 13x75 mm (1.5 mL-4.0 mL) K2EDTA or K3EDTA tubes • Results in 20 minutes • Internal barcode scanner and printer • Automated patient and QC data archive • Easily interfaces to LIS • No reagents; no exposure to patient sample

• 95% correlation to Modified Westergren Method method in 4.0 mL tubes • Compatible with 13x75 mm K 2 EDTA or K 3 EDTA tubes (2.0 mL-4.0 mL) or BD Microtainer® pediatric K 2 EDTA tubes (500 µL) • No reagents; no exposure to patient sample • Random access • Results in 20 minutes; 12 samples per hour • External printer and barcode scanner

Large Capacity

• Automated patient and QC data archive

The internal mixing function automatically prepares up to 30 samples per batch.

• Easily interfaces to LIS

Quality Control Feature

Available for distribution through Streck in Canada, Denmark, Finland, Sweden, Norway and the United States of America, excluding the Commonwealth of Puerto Rico.

The quality control feature eliminates the need to manually record daily runs. Statistical reports are generated with the following features: Levey-Jennings charts, standard deviation, CV%, mean, highest and lowest result.

Associated Product ESR-Chex Plus is a positive procedure control for automated methods that use EDTA tubes. ESR-Chex Plus is manufactured at two levels, normal and abnormal, and contains barcodes for automatic QC file archive. Controlling the sedimentation rate procedure with ESR-Chex Plus allows the clinical laboratory to meet internal quality control standards and regulatory compliance. ESR-Chex Plus Stability

Chemistry

ANALYSIS \ Sed-Rate

CUBE 30 Touch

Closed-vial stability

365 days

Open-vial stability

7 days

Available for distribution through Streck in Canada, Denmark, Finland, Sweden, Norway and the United States of America, excluding the Commonwealth of Puerto Rico.

Quality Control Feature The quality control feature eliminates the need to manually record daily runs. The QC Archive stores up to 5,000 QC results per level. Statistical reports are generated with the following features: Levey-Jennings charts, standard deviation, CV%, mean, highest and lowest result.

Associated Product ESR-Chex Plus is a positive procedure control for automated methods that use EDTA tubes. ESR-Chex Plus is manufactured at two levels, normal and abnormal, and contains barcodes for automatic QC file archive. Controlling the sedimentation rate procedure with ESR-Chex Plus allows the clinical laboratory to meet internal quality control standards and regulatory compliance.

Ordering Information Description

Catalog #

Diesse CUBE 30 Touch Analyzer

240418

Diesse Paper (5 rolls)

240414

Diesse Transponder (500 tests)

240403

Diesse Transponder (1000 tests)

240404

Diesse Transponder (5000 tests)

240419

365 days

Open-vial stability

7 days

Ordering Information Description

Catalog #

Diesse MINI-CUBE Analyzer

240401

Diesse ESR Printer

240402

Diesse ESR Scanner

240405

Diesse Paper (5 rolls)

240414

Diesse Transponder (500 tests)

240403

Diesse Transponder (1000 tests)

240404

Specialty

MINIIMIZE THE HASSLE OF ESR TESTING IN YOUR LAB

See www.streck.com/patents for patents that may be applicable to this product.

Immunoassay

ESR-Chex Plus Stability Closed-vial stability

800.843.0912

| streck.com

880137-2 2019-04

See www.streck.com/patents for patents that may be applicable to this product.

800.843.0912

| streck.com

880111-5 2019-04

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio ELITechGroup Excyte ESR Analyzers

Lab Lead Form HbA1c and Glucose

CLINICAL SYSTEMS Lipid Profile

A U T O M AT E D E S R A N A LY Z E R

Medline POC Influenza A & B / RSV

Erythrocyte Sedimentation Rate

Strep

Additional POC

ESR

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

Coagulation Cardiac

LIS/Resources CLINICAL SYSTEMS

Forms


Lab Portfolio Lab Lead Form

ELITechGroup Excyte ESR Analyzers

HbA1c and Glucose

The Excyte family of automated ESR analyzers by ELITechGroup are packed full of features designed for safety and cost efficiency.

Lipid Profile

The analyzers feature:

Medline POC

Fast results with a sed rate in 30 minutes or less depending upon the analyzer.

Closed Tube Sampling & Testing

Automatic Temperature Correction

Increases the safety of your laboratory personnel by reducing exposure to blood while providing superior reading results.

Delivers better reproducibility of results by normalizing the values to 18°C.

Random Access

Provides the ability to interface to your Laboratory Information System.

Provides your laboratory convenience and flexibility, allowing you to run tests at anytime and in any order.

Excellent Correlation Delivers excellent correlation with the manual Westergren method, giving your laboratory confidence in reporting your results.

RS232 Interface Small Footprint

Influenza A & B / RSV

Strep

Additional POC

Compact, space-saving design is great for tight work spaces.

Meets CLSI and ICSH guidelines

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

Getting an Excyte With the Get Excyted! Placement Program, acquiring an Excyte Automated ESR Analyzer is simple and stress free. Your laboratory agrees to purchase Excyte ESR Tubes (Vacuum or Non-Vacuum) from your distributor each month, and ELITechGroup will provide you with an Excyte analyzer for use in your laboratory. That’s it. Now that is something to Get Excyted! about.

Service & Support No hassle service and support, the way it should be. ELITechGroup’s commitment to providing quality service and support continues with the Excyte family of analyzers. When you acquire an Excyte analyzer through the Get Excyted! Placement Program*, there are no service contracts or hidden costs, it’s all included. You receive unlimited telephone technical support, and if there is a problem with the Excyte analyzer, ELITechGroup sends you a working replacement the same day. When you receive the replacement Excyte analyzer, you send us the analyzer in need of service. That’s it. Now that is something to Get Excyted! about.

* Subject to restrictions, contact your distributor or ELITechGroup for complete details.

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

ELITechGroup Excyte ESR Analyzers

HbA1c and Glucose

Analyzers and Tubes

Lipid Profile Medline POC Influenza A & B / RSV

AUTOMATED

ESR

A N A LY Z E R

Strep

Additional POC

EXCYTE® MINI Fast Results

Performs a complete sed rate test in as little as 15 minutes, with optional pre-indication in 10 minutes. The Excyte Mini holds up to 10 samples, providing your laboratory the capability of performing up to 40 SED RATE TESTS PER HOUR.

Barcode Scanning (Optional)

Quickly scans patient indentification, saving your laboratory valuable time while ensuring positive ID during testing.

Technical Specifications Analyzer Dimensions:

6 in x 8 in x 4 in (H x W x D)

Urinalysis

Hematology

Printer (Optional)

Automatically prints patient results, eliminating transcription errors.

Chemistry

Immunoassay

Weight: 2 lbs

Power Requirements External Power Supply: 100 - 240 Vac, 50/60 Hz Power Consumption: 12 Vdc, 1.5A

Environmental Room Temperature: 15° - 32°C Humidity: 10% - 90%

Product Part No. Excyte Mini (glass tubes) EX-10310 Excyte Mini (plastic tubes) EP-10610

Optional Accessories Excyte Printer Excyte Barcode Scanner

Part No. EX-13886 EX-10551

Specialty

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

ELITechGroup Excyte ESR Analyzers

HbA1c and Glucose

Analyzers and Tubes

Lipid Profile Medline POC Influenza A & B / RSV

AU TO MAT E D

ESR

A N A LY Z E R

Strep

Additional POC

EXCYTE® 20 Fast Results & High Capacity Performs a complete sed rate test in as little as 15 minutes. The Excyte 20 holds up to 20 samples, providing your laboratory the capability of performing up to 80 SED RATES PER HOUR.

Mixing

Printer

On-board mixing provides a more consistent mix and eliminates transfer time from an external mixer to the analyzer, which increases reliability of results while saving time.

The built-in printer automatically prints patient and QC results after each test is complete, eliminating the possibility of transcription errors. You can also print all stored tests and QC data.

On Board Quality Control

Barcode Scanner

Allows lot number and value range entry for normal and abnormal controls, stores daily QC results for quick retrieval, and automatically creates Yudon Plot graphs to quickly analyze daily QC results.

The built-in barcode scanner quickly scans and stores patient identification, saving your laboratory valuable time.

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

Patient Results Archive Stores up to 500 patient results with ID that can be retrieved on screen or printed at any time.

Technical Specifications Analyzer Dimensions:

8.5 in x 13.5 in x 10.5 in (H x W x D)

Power Requirements External Power Supply: 100 - 240 Vac, 50/60 Hz Power Consumption: 12 Vdc, 3.5A

ESR Blood Gas Weight: 11 lbs Environmental Room Temperature: 15° - 32°C Humidity: 10% - 90%

Coagulation Cardiac

Product Part No. Excyte 20 (glass tubes) EX-10318 Excyte 20 (plastic tubes) EP-10618

LIS/Resources Forms


Lab Portfolio Lab Lead Form

ELITechGroup Excyte ESR Analyzers

HbA1c and Glucose

Analyzers and Tubes

Lipid Profile Medline POC

AU TO MAT E D

ESR

Influenza A & B / RSV

A N A LY Z E R

Strep

EXCYTE® 40

Additional POC

Fast Results & High Capacity Performs a complete sed rate test in 30 minutes, with pre-indication in 9 minutes. The Excyte 40 holds up to 40 samples, providing your laboratory the capability of performing up to 80 SED RATES PER HOUR.

On Board Quality Control

Barcode Scanner (Optional)

Allows lot number and value range entry for normal and abnormal controls, stores daily QC results for quick retrieval, and automatically creates Yudon Plot graphs to quickly analyze daily QC results.

Quickly scans and stores patient identification, saving your laboratory valuable time.

Printer (Optional) Automatically prints patient and QC results after each test is complete, eliminating the possibility of transcription errors. You can also print all stored tests and QC data.

Technical Specifications Analyzer Dimensions: 8 in x 13 in x 12.25 in (H x W x D) Power Requirements External Power Supply: 100-240 Vac, 47/ 63 Hz Power Consumption: 12 Vdc, 0.75A; 5 Vdc, 0.1A

Mixer (Optional) Mixes samples, providing your laboratory consistent mixing which increases reliability of results while saving time.

Urinalysis

Hematology Chemistry

Immunoassay

MET Certified Provides your laboratory with the confidence that the Excyte 40 meets all safety requirements and regulations.

Specialty ESR

Weight: 12.3 lbs Environmental Room Temperature: 15° - 32°C Humidity: 10% - 90%

Blood Gas

Coagulation Product Excyte 40 (glass tubes) Excyte 40 (plastic tubes)

Part No. EX-10316 EP-10616

Accessories Excyte Printer Excyte Mixer Excyte Barcode Scanner

Part No. EX-13886 EX-10573 EX-10551

Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

ELITechGroup Excyte ESR Analyzers

HbA1c and Glucose

Accessories

Lipid Profile Medline POC Influenza A & B / RSV

D U O - M I X

Strep

Additional POC

EXCYTE® DUO-MIX The Excyte Duo-Mix is a multifunctional mixer perfect for busy laboratories. This compact, quiet mixer is simple to use and designed to perform the mixing of blood samples, controls or other biological liquids. • Accommodates up to 40 samples, plus controls, at one time • Fits either 13 mm or 8-10 mm tubes (13 mm rack sold separately) • Variety of interchangeable racks optimize workflow

• Racks can be stored in multiple locations and can be safely transported to the laboratory for mixing • Compact and quiet

Technical Specifications Analyzer Dimensions: 6.5 in x 14 in x 6.5 in (H x W x D) Weight: 4.25 lbs Power Requirements External Power Supply: AC input 100-240 Vac 1.8A, 50/60 Hz DC output 12VDC 5A Part No. EX-10573 EX-10575

Configuration 40 positions: 8-10 mm tubes Duo-Mix single rack 13 mm tubes

Urinalysis

Hematology Chemistry

Immunoassay

Specialty ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

ELITechGroup Excyte ESR Analyzers

HbA1c and Glucose

Tubes and QC

Lipid Profile

EXCYTE® ESR VACUUM TUBES The proven and reliable Excyte ESR product line features a full range of tubes that includes both glass and plastic tubes. The Plastic ESR tube offers the same direct draw ablility as our glass ESR tubes with the piece of mind that a slip in the laboratory means no exposure to glass sharps and potential pathogens. If your lab is concerned with both safety and accuracy, then the Excyte Plastic ESR Vacuum Tubes meet your needs.

Excyte ESR Vacuum Tubes (Plastic)

Influenza A & B / RSV

• No breaking. Transporting tubes from point of draw to analysis site is made safer. If a tube is dropped, there is no exposure to glass sharps or potential pathogens. • Sterile and pre-filled with sodium citrate for automatic sample dilution • Conveniently packaged in boxes of 50 • Closed system design provides direct sample collection and automatic dilution, which eliminates exposure to blood • Evacuated to draw 1.36 mL sample with a standard needle holder • High altitude tubes available upon request

Strep

Additional POC

Excyte ESR Vacuum Tubes (Glass) • Irradiated and pre-filled with sodium citrate for automatic sample dilution • Conveniently packaged in boxes of 50 • Closed system design provides direct sample collection and automatic dilution, which eliminates exposure to blood • Evacuated to draw 1 mL sample with a standard needle holder

Urinalysis

Hematology

Excyte ESR Non-Vacuum Tubes (Glass) • Irradiated and pre-filled with sodium citrate for automatic sample dilution • Conveniently packaged in boxes of 50 • Non-evacuated for transfer fill and testing Product Excyte ESR Vacuum Tubes (Plastic) Excyte ESR Vacuum Tubes (Glass) Excyte ESR Non-Vacuum Tubes (Glass)

Medline POC

Chemistry

Part No. EP-10605 EX-50205 EX-50100

Immunoassay

ACCU-SED® PLUS ESR BI-LEVEL CONTROL

Specialty

Quality control has never been easier

Accu-Sed Plus ESR Control is a bi-level control for use in monitoring the performance of erythrocyte sedimentation rate procedures (ESR).

18 month dating*

Provides extended shelf life and consistent results over time.

ESR

31 day open vial stability at room temperature Eliminates the need for refrigerated storage or warming time after opening.

Blood Gas

*From date of manufacture

VQC: Accu-Sed Plus QC Program ELITechGroup’s online, real time QC program is provided at no additional cost. Monthly reports assist with routine record-keeping and assist with evaluating the performance of your ESR system by comparing your results to those of other laboratories using the same instrument and the same lot of Accu-Sed Plus controls. Visit www.elitechgroup.com/vqc for details. Contents Normal ESR Control Kit Abnormal ESR Control Kit

Description 5 vials x 8.5 mL 5 vials x 8.5 mL

Part No. DS-71002 DS-71003

Contents ESR Control Evaluation Set ESR Control Set

Description 1 vial x 8.5 mL normal 1 vial x 8.5 mL abnormal 5 vials x 8.5 mL normal 5 vials x 8.5 mL abnormal

Part No. DS-71004

Coagulation Cardiac

LIS/Resources

DS-71005A

Forms


Lab Portfolio Polymedco Sedimat 15® Plus ESR

Sedimat 15® Plus 15 minute, automated ESR reader

Lab Lead Form HbA1c and Glucose

Automated ESR Reader Lipid Profile Medline POC

Random access capability 8 position reader Small footprint Bar code reader LIS compatible Printer available

Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Polymedco Sediten® ESR

Lab Lead Form HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Ordering Information Description

Catalog Number

Sediten Automated Reader Sedimix ESR Tube Mixer Venoplast Vacuum ESR Tubes with Diluent, 2 x 100 Venoplast Vacuum ESR Tubes with Diluent, 10 x 100 Venoplast ESR Tubes with Diluent, 2 x 100 Venoplast ESR Tubes with Diluent, 10 x 100 Venoplast ESR Tubes without Diluent, 2 x 100 Venoplast ESR Tubes without Diluent, 10 x 100 Patient Identifier Tags for Sediten Tubes, 1000 per pack Sed-Chek 2 Control Bi-Level Normal Abnormal

Additional POC

261091 266191 265277 265177 261277 261177 261270 261170 180160

Urinalysis

Hematology

ESR-2CT ESR-2CTN ESR-2CTA

Chemistry

Immunoassay

Specialty

ESR

Polymedco is a comprehensive diagnostics manufacturer, marketing, and distribution company with complete support departments, including customer service, technical service, and reimbursement.

P

Blood Gas

Coagulation

POLYMEDCO, Inc.

510 Furnace Dock Road Cortlandt Manor, NY 10567 Phone: 800-431-2123 914-739-5400 Customer Service / Ordering Department Fax: 914-739-5890 Reimbursement Support Hotline: Extension 285 www.polymedco.com info@polymedco.com

Cardiac

LIS/Resources

. . . Your Innovative Partner Since 1980 . . .  Copyright August 2011 Polymedco, Inc.

Sediten, Sedimix, and Venoplast are Registered Trademarks of LP ITALIANA, SPA Sed-Chek is a Registered Trademark of Polymedco, Inc.

PN 80224-01

Forms


Lab Portfolio Alcor iSED ESR

Lab Lead Form HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty ESR Blood Gas

THE PERFECT ESR SYSTEM

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Alcor iSED ESR

miniSED® WORKS

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

RHEOLOGY TECHNOLOGY The iSED® is the first in the line of Erythrocyte Sedimentation Rate (ESR) analyzers from ALCOR Scientific Inc.

Strep

The iSED® is a 20 position fully automated ESR analyzer that works directly from the primary EDTA tube and requires just 100 microliters of sample to delivertoa quantify result in just seconds. formation, which is the earliest and most critical SED® utilizes photometric readings the20Rouleaux

sedimentation.

Hematology

ALCOR Scientific photometric readingvariables to quantifycommonly the Rouleauxassociated formation, which is the earliestESR SED® technology makes utilizes it possible to eliminate with traditional andas most critical phase of sedimentation. Our analyzers’ micro-flow cell captures the critical kinetics of ologies, such hematocrit, MCV and temperature. RBCs in a highly controlled testing environment to produce ESR results in 15-20 seconds. The analyzers’ OR EMERGENCY POL,byAND IDEAL AS A BACKUP ANALYZER IN THE HOSPITAL results ROOMS, are unaffected variables commonly associated with traditional ESR TYPICAL testing methods. SomeLABORATORY. of these variables include hematocrit, MCV, and temperature.

IFICATIONS

of measure

Photometrical rheoscope STAT ESR RESULTS

l range

equirements

Fast, accurate and reliable results in 1-130mm/hr just 20 seconds. 100μL whole blood (500μL dead volume)

uirements

13 x 75mm test tube in MINIMAL SAMPLE SIZE

EDTA anti-coagulant, capped Only 100μL of sample is required for testing. Internal

reader

EVERYTHING YOU NEED TO GET STARTED miniSED® Automated ESR Analyzer Test Card of various denominations Seditrol® Quality Control Kit

Serial RS232 port for LIS connection

quirements

ons

Urinalysis

The iSED® maximizes laboratory efficiency with a continuous, random access feed and high throughput

of 180 perseconds! hour. are obtained lesssample than 17

ontrol

Additional POC

Chemistry

Immunoassay

Specialty ESR Blood Gas

Coagulation

FULLY AUTOMATED

100-240VAC; 50-60Hz; 160W Barcode reader, mixer, and printer quality control areHuman-based all internal.

Cardiac

24 x 18 x 26 cm (9.5 x 7.1 x 10.4 in)

LIS/Resources ALCORSCIENTIFIC.COM 112-09-054 07/2019

Forms


Lab Portfolio Lab Lead Form

Alcor miniiSED ESR

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay ™

Specialty ESR Blood Gas

MINIIMIZE THE HASSLE OF ESR TESTING IN YOUR LAB

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Alcor miniiSED ESR

Lab Lead Form

miniSED® WORKS

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

RHEOLOGY TECHNOLOGY Strep

The miniiSED™ is the latest addition to the line of Erythrocyte Sedimentation Rate (ESR) analyzers from ALCOR Scientific Inc.

Additional POC

The miniiSED™ is a single position, fully automated ESR analyzer that works directly from the primary EDTA tube and requires just 100

SED® utilizes photometric readings to quantify the Rouleaux formation, which is the earliest and most critical microliters of sample to deliver a result in just 15 seconds. sedimentation.

Theless miniiSED’s small footprint and advanced features like its integrated barcode reader and touch re obtained than 17 seconds!

screen user interface, together with its rapid time to result make it the ideal solution to ESR testing

for small makes laboratories, POL’s, and emergencyvariables clinics. commonly associated with traditional ESR SED® technology it possible to eliminate logies, such as hematocrit, MCV and temperature.

ALCOR Scientific utilizes photometric reading to quantify the Rouleaux formation, which is the earliest ROOMS, and most POL, criticalAND phase of sedimentation. Our analyzers’ micro-flow cell captures the critical OR EMERGENCY IDEAL AS A BACKUP ANALYZER IN THE TYPICAL HOSPITAL LABORATORY. kinetics of RBCs in a highly controlled testing environment to produce ESR results in 15-20 seconds. The analyzers’ results are unaffected by variables commonly associated with traditional ESR testing methods. Some of these variables include hematocrit, MCV, and temperature.

FICATIONS

of measure range

quirements

irements

1-130mm/hr Fast, accurate and reliable results in whole blood (500μL dead volume) just100μL 15 seconds.

Only 100μL of sample is required for Internal testing. Serial RS232 port for LIS connection

uirements

ns

MINIIMIZE TAT

13 x 75mm test tube in EDTA anti-coagulant, capped MINIIMIZE SAMPLE SIZE

eader

ontrol

Photometrical rheoscope

EVERYTHING YOU NEED TO GET STARTED miniSED® Automated ESR Analyzer Test Card of various denominations Seditrol® Quality Control Kit

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

Coagulation

100-240VAC; 50-60Hz; 160W MINIIMIZE COSTS Improve workflow while reducing test Human-based quality control time and money spent running sed rates. 24 x 18 x 26 cm (9.5 x 7.1 x 10.4 in)

Cardiac

LIS/Resources ALCORSCIENTIFIC.COM 1017-09-200 07/2019

Forms


Lab Portfolio Lab Lead Form

Streck CUBE 30 Touch

HbA1c and Glucose

ANALYSIS \ Sed-Rate Lipid Profile

CUBE 30 Touch Medline POC

An automated instrument for high-volume erythrocyte sedmentation rate testing in EDTA tubes. • 94% correlation to Modified Westergren Method • Compatible with 13x75 mm (1.5 mL-4.0 mL) K2EDTA or K3EDTA tubes • Results in 20 minutes • Internal barcode scanner and printer • Automated patient and QC data archive • Easily interfaces to LIS • No reagents; no exposure to patient sample

Influenza A & B / RSV

Strep

Large Capacity

Additional POC

The internal mixing function automatically prepares up to 30 samples per batch.

Quality Control Feature

Available for distribution through Streck in Canada, Denmark, Finland, Sweden, Norway and the United States of America, excluding the Commonwealth of Puerto Rico.

The quality control feature eliminates the need to manually record daily runs. Statistical reports are generated with the following features: Levey-Jennings charts, standard deviation, CV%, mean, highest and lowest result.

Urinalysis

Hematology

Associated Product ESR-Chex Plus is a positive procedure control for automated methods that use EDTA tubes. ESR-Chex Plus is manufactured at two levels, normal and abnormal, and contains barcodes for automatic QC file archive. Controlling the sedimentation rate procedure with ESR-Chex Plus allows the clinical laboratory to meet internal quality control standards and regulatory compliance.

Chemistry

Immunoassay

ESR-Chex Plus Stability Closed-vial stability

365 days

Open-vial stability

7 days

Specialty Ordering Information Description

Catalog #

Diesse CUBE 30 Touch Analyzer

240418

Diesse Paper (5 rolls)

240414

Diesse Transponder (500 tests)

240403

Diesse Transponder (1000 tests)

240404

Diesse Transponder (5000 tests)

240419

ESR Blood Gas

Coagulation Cardiac

LIS/Resources

See www.streck.com/patents for patents that may be applicable to this product.

800.843.0912

| streck.com

880137-2 2019-04

Forms


Lab Portfolio Streck MINI-CUBE

Lab Lead Form

ANALYSIS \ Sed-Rate

HbA1c and Glucose

MINI-CUBE

Lipid Profile

An automated instrument for high-volume erythrocyte sedmentation rate testing in EDTA tubes.

Medline POC

• 95% correlation to Modified Westergren Method method in 4.0 mL tubes • Compatible with 13x75 mm K 2 EDTA or K 3 EDTA tubes (2.0 mL-4.0 mL) or BD Microtainer® pediatric K 2 EDTA tubes (500 µL)

Influenza A & B / RSV

• No reagents; no exposure to patient sample • Random access

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• Results in 20 minutes; 12 samples per hour • External printer and barcode scanner • Automated patient and QC data archive • Easily interfaces to LIS Available for distribution through Streck in Canada, Denmark, Finland, Sweden, Norway and the United States of America, excluding the Commonwealth of Puerto Rico.

Additional POC

Quality Control Feature The quality control feature eliminates the need to manually record daily runs. The QC Archive stores up to 5,000 QC results per level. Statistical reports are generated with the following features: Levey-Jennings charts, standard deviation, CV%, mean, highest and lowest result.

Associated Product ESR-Chex Plus is a positive procedure control for automated methods that use EDTA tubes. ESR-Chex Plus is manufactured at two levels, normal and abnormal, and contains barcodes for automatic QC file archive. Controlling the sedimentation rate procedure with ESR-Chex Plus allows the clinical laboratory to meet internal quality control standards and regulatory compliance. ESR-Chex Plus Stability Closed-vial stability

365 days

Open-vial stability

7 days

Urinalysis

Hematology Chemistry

Immunoassay

Specialty

Ordering Information Description

Catalog #

Diesse MINI-CUBE Analyzer

240401

Diesse ESR Printer

240402

Diesse ESR Scanner

240405

Diesse Paper (5 rolls)

240414

Diesse Transponder (500 tests)

240403

Diesse Transponder (1000 tests)

240404

ESR Blood Gas

Coagulation Cardiac

LIS/Resources

See www.streck.com/patents for patents that may be applicable to this product.

800.843.0912

| streck.com

880111-5 2019-04

Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

Blood Gas Siemens RapidPoint 500

Siemens epoc Blood Analysis System

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC RAPIDPoint 500 Blood Gas Systems

Advance your blood gas testing

with trusted technology that’s easy to use.

Right Result.

Right Here. Right Now.

epoc Blood Analysis System

Improve outcomes and workflow while transforming care delivery across clinical pathways. The epoc® Blood Analysis System gives you lab-quality results here and now.

Urinalysis

usa.siemens.com/rp500

usa.siemens.com/epoc

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Siemens RapidPoint 500

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

RAPIDPoint 500 Blood Gas Systems

Advance your blood gas testing

with trusted technology that’s easy to use.

Specialty

ESR Blood Gas

Coagulation

Cardiac LIS/Resources

usa.siemens.com/rp500

Forms


Lab Portfolio Lab Lead Form

Siemens RapidPoint 500

RAPIDPoint 500 analyzers meet your

critical care testing needs using

proven technology and features designed to work in point-of-care settings.

The demand for point-of-care testing is increasing. Do you have a solution that works for everyone? Your referring physicians and their patients want answers fast, at the point of care—answers that lead to improved clinical decision making and expedited treatment strategies. But your point-of-care testing needs don’t end there. Your core lab team has concerns about accuracy, quality control (QC), and compliance of decentralized instruments. The wide variety of clinicians who use the analyzers demand that they be available, easy to operate, and maintenance-free. And your POC team expects systems that are as technically robust as they are clinically accurate. RAPIDPoint® 500 Blood Gas Systems are designed to satisfy the unique demands of testing at the point of care so that everybody wins.

A solution for time-pressured testing

Fast and flexible point-of-care design

Our RAPIDPoint 500 Blood Gas Systems deliver accurate, laboratory-quality test results for a comprehensive menu of critical care parameters in approximately 60 seconds— pH and blood gases, electrolytes, glucose, lactate, and fully integrated CO-oximetry, including neonatal bilirubin (nBili) and total hemoglobin (tHb)—all from a single whole-blood sample. The system also reports osmolality (mOsm), supports pH testing of pleural fluid samples, and can record ventilator settings and custom demographics to enhance clinical decision making.

Count on RAPIDPoint 500 systems to be ready to use without slowing down hospital staff with complex operating procedures and maintenance tasks. RAPIDPoint 500 systems enable users to perform faster testing.

Reliable technology you can trust To give you more confidence in your results, the RAPIDPoint 500 Blood Gas System uses Siemens Healthineers technology that has been performance-proven for more than a decade. • Maximize uptime with 28-day measurement cartridge containing a full complement of critical care analytes without gas tanks or reagent bottles. • Preserve sample integrity and improve safety with a hands-free sample port, automated sample aspiration, self-cleaning probe, and clot-detection features. • Minimize risk with cartridge-based system design, integrated planar sensors, and patented slide cell technology for CO-oximetry. • Ensure accuracy and simplify compliance with automatic QC and calibration systems.

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

• Increase efficiency with preset custom panels for the most frequently used tests; just scan the ID, insert sample, and touch Start.

Chemistry

• Optimize viewing and reduce glare with an adjustable touchscreen.

Immunoassay

• Ensure error-free data capture with an integrated barcode reader for fast, single-handed scans of patient or operator ID.

Specialty

• Improve ease of use with a single sample port that accepts syringe or capillary samples without adapters. • Reduce downtime with 28-day measurement and AQC cartridges. • Minimize delays for STAT patient samples by interrupting automatic QC and calibration functions. • View QC data and trending with onboard LeveyJennings chart. • Simplify training and day-to-day operation with built-in instructional videos. • Upgrade software and back up results quickly and easily with USB ports. • Communicate simultaneously with up to two laboratory information or data-management systems over serial and Ethernet ports. The RAPIDPoint 500 system also supports wireless roaming. • Create hard copies of patient results in just 60 seconds using the integrated printer.

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Siemens RapidPoint 500

HbA1c and Glucose

Lipid Profile

RAPIDPoint 500 Test Menu

Medline POC

• Blood Gas: pH,† pO2, pCO2 Influenza A & B / RSV

• Electrolytes: Na+, K+, Ca++, Cl• Metabolites: Glucose, lactate • CO-oximetry: nBili, tHb, SO2, O2Hb, HHb, COHb, MetHb

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†pH results also available using pleural fluid* sample.

The technology you trust for the tests you need

Maximized efficiency with the RAPIDComm Data Management System Take efficiency to the next level by seamlessly integrating your RAPIDPoint 500 analyzers with the RAPIDComm® Data Management System. Centralize management of our analyzers and up to 5000 instrument operators to standardize testing procedures, facilitate compliance, and improve risk management. • Remotely configure, monitor, and control networked POC analyzers from the comfort of your office.

Every RAPIDPoint 500 system feature has been designed to save your clinicians valuable time as they make the critical decisions that directly impact patients’ lives. You can count on the instrument to be available when it’s needed and perform consistently—with laboratory-quality results— when in use. And we are committed to expanding its functionality and data-management capabilities as your test requirements and information needs evolve. Experience the benefits of a critical care testing solution based on the proven technology that only we can deliver.

Learn more at usa.siemens.com/rp500

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

• Centralize operator management to limit instrument access to trained and authorized users. • Help ensure regulatory compliance through event monitoring and reports for calibrations, maintenance, audit trail, linearity, and proficiency testing.

Specialty Central Laboratory LIS

Emergency Department, Recovery Room, NICU

Critical Care

ESR Blood Gas

Endocrinology

Diabetes Care

RAPIDComm Data Management System

Coagulation

Blood Gas

Cardiac Urology

LIS/Resources Urinalysis

Labor and Delivery Suite

Surgical Suite

Forms


Lab Portfolio Lab Lead Form

Siemens RapidPoint 500

HbA1c and Glucose

RAPIDComm, RAPIDPoint, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR

Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Phone: +49 9131 84 0 siemens.com/healthineers

Local Contact Information Siemens Healthcare Diagnostics Inc. Point of Care Diagnostics 2 Edgewater Drive Norwood, MA 02062-4637 USA Phone: +1 781-269-3000 siemens.com/healthineers

Blood Gas

Coagulation

Cardiac LIS/Resources Order No. A91DX-POC-170236-UC1-4A00 | 06-2017 | © Siemens Healthcare Diagnostics Inc., 2017

Forms


Lab Portfolio Siemens epoc Blood Analysis System

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Right Result.

Right Here. Right Now.

epoc Blood Analysis System

Improve outcomes and workflow while transforming care delivery across clinical pathways. The epoc® Blood Analysis System gives you lab-quality results here and now.

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources usa.siemens.com/epoc

Forms


Lab Portfolio Lab Lead Form

Siemens epoc Blood Analysis System

Don’t second-guess when every second counts.

HbA1c and Glucose

Lipid Profile

The epoc system is a handheld, wireless solution that provides blood gas, electrolyte, and metabolite results at the patient’s side in less than one minute. Accelerate Clinical Decision Making Empower clinicians to make faster decisions with lab-quality results at the patient’s side, enhancing clinical decision making and improving patient outcomes. Simplify Inventory Management By incorporating a full menu on a single, room temperature-stable test card bar-coded for quality assurance, the epoc system delivers a more efficient and easy-to-manage patientside testing program.

Streamline Patient-testing Workflow By moving testing to the patient’s side, caregivers, patients, and hospital administration all benefit from a less-complex testing process that improves turnaround times, patient care, and operational efficiencies. Deliver Real-time Results and Reporting With an integrated, wireless connection, you can easily transmit results from the patient’s side to the EMR/LIS/HIS in real time and gain centralized control of decentralized testing.

LAN

EMR

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Discover the power of an open POC Ecosystem™ with point-of-care informatics solutions that can simplify your POCT workflows and dramatically reduce workload for your staff. Electronically send test results from all connected POCT devices directly to electronic patient records. Centrally manage all POCT devices, patient results, operators, reagents, and quality control materials.

Blood Gas

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens epoc Blood Analysis System

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Siemens epoc Blood Analysis System epoc, POC Ecosystem, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas

Coagulation Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84-0 siemens.com/healthineers

Local Contact Information Siemens Healthcare Diagnostics Inc. Point of Care Diagnostics 2 Edgewater Drive Norwood, MA 02062-4637 USA Phone: +1 781-269-3000

Published by Siemens Healthcare Diagnostics Inc. · Order No. 40-18-11115-01-76 · 02-2018 · © Siemens Healthcare Diagnostics Inc., 2018

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

Coagulation Coag-Sense PT/INR System

Roche CoaguChek XS System

More than 2 million patients on vitamin K antagonists around the world are testing with a CoaguChek® system

Lipid Profile Medline POC

Siemens Xprecia Stride

Siemens Hemostasis Solutions

Influenza A & B / RSV

Strep So small,

it can fit in your pocket.

1 2 3

Additional POC

So accurate,

References Plesch, W., Wolf, T., Dikkeschei, B. (2007). INR results of the CoaguChek XS Plus are equivalent to those of the CoaguChek XS system. Poster presented at the ISTH Congress, July 9, Geneva, Switzerland. Matchar, D.B., Jacobson, A., Dolor, R., Edson, R., Uyeda, L. et al. (2010). Effect of home testing of international normalized ratio on clinical events. N Engl J Med 363, 1608-1620. Heneghan, C., Alonso-Coello, P., Garcia-Alamino, J.M., Perera, R., Meats, E., Glasziou, P. (2006). Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet; 367:404-411.

it could go in a lab.

With the new Xprecia Stride Coagulation Analyzer, Siemens Healthineers answers the need for accuracy at the point of care. Primary care, urgent care, and hospitals are locations that demand fast, reliable PT/INR testing. That’s why Siemens Healthineers is introducing the Xprecia Stride™ Coagulation Analyzer, a true handheld device to test PT/INR with lab accuracy.* With the Xprecia Stride Coagulation Analyzer, healthcare professionals can feel confident that they are getting the usability, safety, efficiency, and accuracy they need. The Xprecia Stride Coagulation Analyzer is designed specifically to meet the needs of today’s healthcare professionals and address the key areas of importance in POC testing:

The most precise point-of-care PT/INR system COAGUCHEK and BECAUSE IT’S MY LIFE are trademarks of Roche. EVER!

CoaguChek® XS system The smart way to test your INR at home

©2014 Roche

Intelligent design on a proven detection CH-6343 Rotkreuz platform Roche Diagnostics International Ltd

Usability

Safety

• Touchscreen features include a bright-color interface with step-by-step instructions to help guide the user • Display shows clear, easy-to-read results to enable better patient consultations • Lot calibration is simple using integrated bar-code scanner

• Test strip eject button reduces potential biohazard exposure • Operator lockout feature restricts analyzer use to trained staff only • Data transfer occurs seamlessly and securely via USB connection to ensure patient data confidentiality

Efficiency

Accuracy

• Design is compact and portable to enable fast, efficient patient testing at the point of care • Test requires only a small sample applied at tip of strip to allow quick, easy, and efficient testing • Tutorials facilitate operator training with intuitive onscreen animation

• Lab confirmatory testing may be reduced because of good correlation to lab results • Xprecia™ PT/INR test strips and Siemens Healthineers central lab analyzers use the same Dade® Innovin® reagent and liquid QC for consistency • Bar-code scanner offers fast, accurate patient and operator ID entry with optional manual entry on touchscreen

Urinalysis

*Cleared for use in moderately complex settings.

Switzerland

www.coaguchek.com

usa.siemens.com/xprecia 1 of 6

Hematology Siemens Sysmex CS-5100

Siemens Sysmex CS-2500

Siemens Sysmex CA-600

Siemens BCS XP

Chemistry

Immunoassay

Specialty

ESR

Siemens BFT II

Siemens PFA-100

Blood Gas Coagluation Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio Coag-Sense PT/INR System

Coag-Sense PT/INR Meter ABO03P7002 1/ea 18.682.17.26

Placement Agreement

Coag-Sense PT/INR Test Strips ABO03PTESTKIT 50 ea/bx 18.3.68.23.64

Lab Lead Form HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty

ESR Blood Gas

The most precise point-of-care PT/INR system EVER! Intelligent design on a proven detection platform

Coagluation Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio

Coag-Sense PT/INR Meter ABO03P7002 1/ea 18.682.17.26

Placement Agreement

Coag-Sense PT/INR System

Coag-Sense PT/INR Test Strips ABO03PTESTKIT 50 ea/bx 18.3.68.23.64

Lab Lead Form HbA1c and Glucose

INTRODUCING: THE NEW COAG-SENSE® PT2 METER

Lipid Profile

Touchscreen

Medline POC

Home Screen Button

Influenza A & B / RSV Cancel or Previous Screen Button

Strep

NFC Chip Scanner

On/Off Button

Additional POC Urinalysis

View Menu Button

Hematology Strip Insertion Area

TOP VIEW

Chemistry Ethernet Port (With Cover)

USB Port

Reset Button (Enclosed Inside) Micro USB Power Adapter

Immunoassay

Specialty

ESR ACCESSORIES Patient Test Strips

Sample Transfer Tubes w/Plunger

Control Strips & Activation Solution

Blood Gas Portable Printer

Coagluation Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio

Coag-Sense PT/INR Meter ABO03P7002 1/ea 18.682.17.26

Placement Agreement

Coag-Sense PT/INR System

Coag-Sense PT/INR Test Strips ABO03PTESTKIT 50 ea/bx 18.3.68.23.64

Lab Lead Form HbA1c and Glucose

EXPERIENCE THE BENEFITS OF SUPERIOR ACCURACY, PRECISION, AND SAFETY Self-Testing - more frequent results benefit patients

Proven Methodology ˃

Micro-mechanical detection process offers superb accuracy and precision

˃

Not susceptible to changes in Hemoglobin & Hematocrit levels

˃

Ability to run whole blood, real plasma controls, and plasma calibrants

˃

Testing time is patient´s actual clotting time - nothing is faster than that

˃

The only CLIA-Waived system that produces a true prothrombin time - a simple clot timer

˃

Linear response even in the high INR range - often out performs lab systems!

˃ ˃ ˃ ˃ ˃

˃

Only POC system that directly detects clotting endpoint (emulates the WHO Tilt-Tube method)

˃ ˃

Offers gold standard accuracy and precision (CV 2.5%)

˃ ˃

Displays PT results in less than 1 minute

Determines actual PT time without look-up tables or curve-f itting algorithms INR range f rom 0.8 to 8.0

Simple & accurate sample collection ˃ ˃ ˃ ˃

Small sample size - just one 10 μL drop of blood

˃

Supports proper bloodborne-pathogen control compliance

Sample transfer tubes included

Medline POC

Testing at home is a safe and convenient option Simplicity of design give better conf idence in results Offers full point-of-care reportable range up to 8.0 INR

Influenza A & B / RSV

Conveniently portable, connected design Sends results to service provider using app

Extending control through the continuum of care

A more direct approach to INR

Lipid Profile

˃

Consistency of monitoring f rom hospital, to clinics, to home; same meter, same test strips, same reportable range

˃

Safety prof ile puts both home testers and their clinicians at ease

˃

Included sample transfer tubes ensures proper blood volume and technique

˃ ˃

Communicates patient´s home testing results to provider

˃

Medicare covers weekly home PT/INR monitoring for patients with a variety of conditions

˃

Independent Diagnostic Testing Facility (IDTF) supervision ensures compliance

˃

Superb IDTF home testing partners

Strep

Additional POC Urinalysis

Improve testing adherence with test f requency monitoring and easy supply fulf illment requesting

Hematology Chemistry

Allows stable accurate transfer of sample to test strip Reduces errors and wasted strips with correct volume delivery

Track Patient Results Quickly plot patient result history to get a complete picture of time in therapeutic range.

Immunoassay

Multiple Connectivity Options The Coag-Sense system offers clinics and patients wireless (Wi-Fi and Bluetooth) and wired (USB and Ethernet) connectivity options for sending results data to electronic health records, testing service providers, or data management systems. ®

Near Field Communication (NFC) Set Target Ranges & Alarms Target therapeutic ranges and testing alarms can be set to aid in testing f requency and reviewing test results easily.

Color Touchscreen The user friendly color touchscreen makes the Coag-Sense ® meter simple to use. The display instructions are easy to read, understand, and follow.

Data Entry Made Easy Using an optional wired or wireless bar code scanner, operator, and patient ID can be quickly captured for data management.

Test strip lot information is quickly and easily communicated wirelessly to the Coag-Sense® meter via an NFC chip on the test strip kit box.

www.coag-sense.com

Specialty

ESR Blood Gas

Coagluation Coagulation Cardiac

LIS/Resources Forms


Lab Portfolio

Coag-Sense PT/INR Meter ABO03P7002 1/ea 18.682.17.26

Placement Agreement

Coag-Sense PT/INR System

Coag-Sense PT/INR Test Strips ABO03PTESTKIT 50 ea/bx 18.3.68.23.64

Lab Lead Form

SENSIBLE PT/INR TESTING IN THE PALM OF YOUR HAND How to use the Coag-Sense PT/INR Meter

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep Step 1

Step 2

Step 3

Step 4

Insert a test strip

Lance finger and collect a bead of blood with included transfer tube

Dispense sample onto test strip

Wait for results (testing time is the patient’s actual clotting time)

Professional User Ordering Information 03P70-04 COAG-SENSE STARTER BUNDLE ®

03P70-02 COAG-SENSE® PRO PT/INR SYSTEM (meter only) 03P56-50 COAG-SENSE® PT/INR TEST STRIP KIT 03P58-04 COAG-SENSE® LANCETS AUTO SINGLE USE, 21G, 2.2mm depth - BOX OF 100

Cleared for home use Cleared for professional use Sample size Sampling method Device specifications Display

Self-Test User Ordering Information 03P70-01 COAG-SENSE® SELF-TEST PT/INR SYSTEM (meter only) 03P56-50 COAG-SENSE® PT/INR TEST STRIP KIT 03P58-04 COAG-SENSE® LANCETS AUTO SINGLE USE,21G, 2.2mm depth - BOX OF 100

Size Weight Test strips packaging Storage Strip lot communication

Accessories

Connectivity

03P78-01 BAR CODE SCANNER 03P76-01 COAG-SENSE® PORTABLE PRINTER, USB, BLUETOOTH AND WI-FI PD-99906 PORTABLE PRINTER PAPER, 5 ROLLS 03P58-04 COAG-SENSE® LANCETS AUTO SINGLE USE,21G, 2.2mm depth - BOX OF 100 03P69-10 COAG-SENSE CONTROL TEST STRIP KIT -10 ®

03P52-54 COAG-SENSE® SAMPLE TRANSFER TUBES, VIAL OF 54 03P52-55 COAG-SENSE® SAMPLE TRANSFER TUBES - PRELOADED, VIAL OF 54

Current Procedural Test (CPT) codes Prothrombin time

85610

CLIA-Waived PT test

85610QW

(510) 270-5442 (510) 226-6540 (Fax) Toll free (866) 903 0890

Connectivity interface Heparin sensitive Hematocrit range Clot detection principle INR range Prothrombin time (PT) ISI Analysis time

03P74-01 POWER SUPPLY

CoaguSense Inc. 48377 Fremont Blvd, Ste 113 Fremont, CA 94538

Barcode scanning

QC QC & operator lockouts

Coag-Sense® is a registered trademark of CoaguSense Inc.

PN 200466 Rev AA

1 drop (10 µL) capillary blood minimum 21g lancet; sample transfer tube Portable

5.9 in (150 mm) x 3.9 in (100 mm) x 1.2 in (30 mm) 11.3 ounces (0.32 kg)

Chemistry

Individually pouched in boxed quantities Non-refrigerated; up to 24-month shelf life Near Field Communication (NFC) chip

Immunoassay

Wired: Ethernet, USB | Wireless: Wi-Fi, Bluetooth Yes - Optional USB or Bluetooth scanner POCT1A/HL7 to LIS/HIS/Middleware

Specialty

Yes - POC devices not recommended for bridging 15% - 60% Direct micro-mechanical 0.8-8.0

ESR

8-80 seconds ~ 1.0 <1 minute (Patient actual clotting time)

Blood Gas

External using control strips containing plasma Yes using control strips containing plasma

Printing

Yes with optional Bluetooth, USB, or Wi-Fi printer

Warranty

Hematology

TFT color LCD touchscreen

2,000 patient test results, 500 QC test results

Operating temperature

Urinalysis

Yes - CLIA-Waived

Memory

Power source info@coagusense.com www.coag-sense.com

Yes - Patient self-testing (Prescription required)

Additional POC

Built-in lithium polymer rechargeable battery 65º F to 90º F (18º C to 32º)

Coagluation Coagulation Cardiac

1 year with immediate replacement

Visit www.coag-sense.com/tech-specs or scan the QR code on the right with your smart phone for training videos and detailed user information.

LIS/Resources

www.coag-sense.com

Forms


Lab Portfolio Lab Lead Form

Roche CoaguChek XS System

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology Chemistry

Immunoassay

Specialty

CoaguChek® XS system The smart way to test your INR at home

ESR Blood Gas

Coagluation Coagulation Cardiac

LIS/Resources Forms 1 of 6


Lab Portfolio Lab Lead Form

Roche CoaguChek XS System

CoaguChek® XS system INR monitoring has never been so easy

HbA1c and Glucose CoaguChek Offers you mo Lipid Profile Medline POC

There has been an extraordinary increase in the use of vitamin K antagonists (VKAs), driven mainly by an aging population. Millions of people worldwide are now taking VKAs for a variety of conditions. They need a regular blood test called the international normalized ratio (INR) to check that their VKA is working as it should.

Influenza A & B / RSV

Strep

This test can be done at home using a small drop of blood from the fingertip. Since 1993, CoaguChek systems from Roche have set the standard in point-of-care INR testing for patients on oral anticoagulant therapy. More than 2 million patients on VKAs around the world are testing with a CoaguChek system: you can be confident you’re making the right decision by choosing a CoaguChek XS system today. Just a few easy steps and one minute to your INR results

Additional

… safety · Onboard with no · Results v XS Plus · Frequen · allow POC · increa · reduc

Urinalysis

… indepen · Use the to test a · Take con Hematology· Increase

Chemistry 1) Insert the test strip into the device (insertion automatically switches the device on).

2) Prick your fingertip with the CoaguChek XS Softclix lancing device to get a drop of blood.

3) Apply the first drop of blood within 15 seconds. Sideor top-dosing on the test strip makes dosing very easy.

4) Get your INR result within seconds.

… confiden · Over 20 · Over 2 m · Consiste · Trend an

Immunoassay … comfort Specialty

· · · ·

ESR

· · ·

Blood Gas

Coagluation Coagulation Cardiac

LIS/Resources

2 of 6

Forms

About 1 Tiny fing Virtually lancing d Easy blo meter fo One-but Large, ea Strips st


Lab Portfolio Lab Lead Form

Roche CoaguChek XS System

CoaguChek® XS system Offers you more…

CoaguChe INR monit Lipid Profile The smart w

HbA1c and Glucose

Medline POC Influenza A & B / RSV … safety · Onboard control on every strip in the measuring channel, with no need to run liquid controls · Results virtually identical to those achieved with CoaguChek XS Plus system/CoaguChek XS Pro system1 · Frequent testing: · allows timely dosage changes · increases time in therapeutic range2 · reduces adverse events3 … independence · Use the small, light and easily portable CoaguChek system to test anywhere, anytime, at home or on the go · Take control of your condition · Increase your quality of life … confidence · Over 20 years of Roche experience in INR monitoring · Over 2 million patients tested using CoaguChek systems · Consistent results, with all tests coming from a single source · Trend analysis thanks to storage of up to 300 test results … comfort · About 1 minute to get an accurate INR result · Tiny fingerstick sample – 1 drop (8 μL) of capillary whole blood · Virtually pain-free sampling using the CoaguChek Softclix lancing device – No need for venous blood sampling · Easy blood application: top- or sidedosing options, outside the meter for patients with limited dexterity · One-button operation – simplifies use · Large, easy-to-read display for patients with limited vision · Strips stable for up to 21 months

Strep

Additional POC Urinalysis INR testing, at home or on the go, using a CoaguChek XS system, can significantly improve your quality of life.

Hematology

Turnaro User in Memor Auto p Power Battery Operat Operat Operat Dimens Weight

Chemistry

Immunoassay

Coagu Blood s Sample

Specialty

Blood a Measu Interna sensitiv

ESR

Calibra

Blood Gas Coagluation Coagulation Cardiac

LIS/Resources Forms 3 of 6

Coagu Test pr

INR rep Heparin

Hemato Quality Stabilit


Lab Portfolio Lab Lead Form

Roche CoaguChek XS System

CoaguChek® XS system for smart INR monitoring The smart way to test your INR at home

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

CoaguChek XS meter Test principle

Electrochemical determination of international normalized ratio (INR) after activating coagulation with human recombinant thromboplastin Turnaround time Approximately 1 min. User interface Simple icon-based LCD Memory capacity 300 test results with date and time Auto power Auto-on with strip insertion; auto-off after 3 min. Power supply 4 x 1.5 V AAA batteries Battery life Up to 300 tests or 2 years Operating temperature +15 °C to +32 °C Operating relative humidity 10 % to 85 % Operating maximum altitude 4,300 m Dimensions 138 x 78 x 28 mm Weight 127 g (without batteries)

Strep

Additional POC Urinalysis

Hematology Chemistry

CoaguChek XS PT test Blood sample size Sample types Blood application Measuring range International sensitivity index (ISI) Calibration INR reproducibility Heparin insensitivity

Hematocrit range Quality control Stability

8 μL Capillary whole blood or non-anticoagulated venous whole blood Top- and 2 side-dosing options, outside the meter INR: 0.8 – 8.0 Approximately 1.0 (in line with World Health Organization (WHO) recommendation) Master lot calibrated directly against international reference method Coefficient of variation (CV) <4.5 % for capillary blood · Heparin concentrations up to 0.8 U/mL · Low molecular weight heparins (LMWH) up to 2 IU/mL antifactor Xa activity 25 – 55 % On-board control on every strip in the measuring channel 21 months from production (+2 °C to +30 °C)

Immunoassay

Specialty

ESR Blood Gas Coagluation Coagulation Cardiac

LIS/Resources Forms 4 of 6


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Roche CoaguChek XS System

HbA1c and Glucose

More than 2 million patients on vitamin K antagonists around the world are testing with a CoaguChek® system

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology References 1

Plesch, W., Wolf, T., Dikkesche Poster presented at the ISTH Matchar, D.B., Jacobson, A., D N Engl J Med 363, 1608-1620 Heneghan, C., Alonso-Coello, a systematic review and meta

2 Chemistry 3

Immunoassay

Specialty

ESR Blood Gas Coagluation Coagulation COAGUCHEK and BECA

are trademarks of Roche.

Cardiac ©2014 Roche

Roche Diagnostics Intern CH-6343 Rotkreuz

LIS/Resources Switzerland

www.coaguchek.com

5 of 6

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Roche CoaguChek XS System

HbA1c and Glucose

Lipid Profile Medline POC Influenza A & B / RSV

Strep

Additional POC Urinalysis

Hematology References 1 2 3

Plesch, W., Wolf, T., Dikkeschei, B. (2007). INR results of the CoaguChek XS Plus are equivalent to those of the CoaguChek XS system. Poster presented at the ISTH Congress, July 9, Geneva, Switzerland. Matchar, D.B., Jacobson, A., Dolor, R., Edson, R., Uyeda, L. et al. (2010). Effect of home testing of international normalized ratio on clinical events. N Engl J Med 363, 1608-1620. Heneghan, C., Alonso-Coello, P., Garcia-Alamino, J.M., Perera, R., Meats, E., Glasziou, P. (2006). Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet; 367:404-411.

Chemistry

Immunoassay

Specialty

ESR

CoaguChek® Gas way TheBlood smart Coagluation Coagulation COAGUCHEK and BECAUSE IT’S MY LIFE are trademarks of Roche.

Cardiac

©2014 Roche Roche Diagnostics International Ltd CH-6343 Rotkreuz

LIS/Resources

Switzerland www.coaguchek.com

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Siemens Xprecia Stride

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

So small,

Urinalysis

it can fit in your pocket.

So accurate,

it could go in a lab.

With the new Xprecia Stride Coagulation Analyzer, Siemens Healthineers answers the need for accuracy at the point of care. Primary care, urgent care, and hospitals are locations that demand fast, reliable PT/INR testing. That’s why Siemens Healthineers is introducing the Xprecia Stride™ Coagulation Analyzer, a true handheld device to test PT/INR with lab accuracy.* With the Xprecia Stride Coagulation Analyzer, healthcare professionals can feel confident that they are getting the usability, safety, efficiency, and accuracy they need. The Xprecia Stride Coagulation Analyzer is designed specifically to meet the needs of today’s healthcare professionals and address the key areas of importance in POC testing:

Usability

Safety

• Touchscreen features include a bright-color interface with step-by-step instructions to help guide the user • Display shows clear, easy-to-read results to enable better patient consultations • Lot calibration is simple using integrated bar-code scanner

• Test strip eject button reduces potential biohazard exposure • Operator lockout feature restricts analyzer use to trained staff only • Data transfer occurs seamlessly and securely via USB connection to ensure patient data confidentiality

Efficiency

Accuracy

• Design is compact and portable to enable fast, efficient patient testing at the point of care • Test requires only a small sample applied at tip of strip to allow quick, easy, and efficient testing • Tutorials facilitate operator training with intuitive onscreen animation

• Lab confirmatory testing may be reduced because of good correlation to lab results • Xprecia™ PT/INR test strips and Siemens Healthineers central lab analyzers use the same Dade® Innovin® reagent and liquid QC for consistency • Bar-code scanner offers fast, accurate patient and operator ID entry with optional manual entry on touchscreen

Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagluation Coagulation

Cardiac LIS/Resources

*Cleared for use in moderately complex settings.

usa.siemens.com/xprecia

Forms


Lab Portfolio Lab Lead Form

Siemens Xprecia Stride

HbA1c and Glucose Test strip port Test strip eject button to reduce potential biohazard exposure

Lipid Profile

Medline POC Color-coded instrument cap to designate users or locations

Large visuals for instructions and results

Influenza A & B / RSV

Strep

Additional POC

Bar-code scanner for lot calibration and operator and patient ID entry

USB connection for transmitting patient and QC results

Urinalysis Hematology

Chemistry For more than 30 years, Siemens Healthineers has been a global leader in hemostasis lab testing. Now, the Xprecia Stride Coagulation Analyzer brings this expertise to the point of care.

Visit usa.siemens.com/xprecia to learn more about the Xprecia Stride Coagulation Analyzer and how it can help healthcare professionals in their specific test settings.

Test with accuracy. Be confident in the result. Siemens Healthineers hemostasis quality from lab to point of care.

Immunoassay

Specialty

Ordering Information

ESR

Part No.

Name

Description

11065584

Xprecia Stride Analyzer Kit

Includes analyzer, USB cable, user documentation and Xprecia Stride DMS DVD

11065645

Xprecia Stride PT/INR Strips

Includes 4 vials of PT/INR test strips (25 strips per vial)

10873633

Xprecia System PT Controls

Liquid quality control (4 vials of PT 1, 4 vials of PT 2, 8 vials of CaCl2 diluent)

Blood Gas

For complete list of replacement parts, please see the Xprecia Stride User Guide.

Coagluation Coagulation Dade, Innovin, Xprecia, Xprecia Stride, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Phone: +49 9131 84 0 siemens.com/healthineers

Order No. A91DX-POC-170095-UC1-4A00 | 03-2017 | © Siemens Healthcare Diagnostics Inc., 2017

Local Contact Information Siemens Healthcare Diagnostics Inc. Point of Care Diagnostics 2 Edgewater Drive Norwood, MA 02062-4637 USA Phone: +1 781-269-3000 siemens.com/healthineers

Cardiac LIS/Resources Forms


Lab Portfolio Siemens Hemostasis Solutions

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagluation Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens Hemostasis Solutions

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation Coagluation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens Hemostasis Solutions

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

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Specialty

ESR Blood Gas Coagluation Coagulation

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Lab Portfolio Siemens Sysmex CS-5100

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagluation Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens Sysmex CS-2500

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagluation Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens Sysmex CA-600

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagluation Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens BCS XP

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation Coagluation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens BFT II

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation Coagluation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens PFA-100

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagluation Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens Hemostasis Solutions

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation Coagluation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

Cardiac Siemens Stratus CS

Lipid Profile

Medline POC Influenza A & B / RSV

Quidel Triage ST9800000EN00.qxp_Layout 1 2/22/18 7:23 AM Page 1

One test. Multiple platforms. Dependable results.

Strep

Access® 2* Immunoassay System

Unicel® Dxl 800* Immunoassay System

Quidel Triage System

Clinically Interchangeable BNP Results Regardless of Platform1 siemens.com/stratus

Rely on Its Proven Performance The Stratus CS Acute Care Diagnostic System is Designed to Best Fulfill Your Near-patient Setting Needs

n

Additional POC

Method comparison of BNP assay results obtained using the Triage Meter versus the Triage BNP assay for Beckman Coulter Immunoassay Systems–BNP measurements of 412 EDTA plasma samples using the Triage BNP testing platforms. A Passing-Bablock regression analysis was applied.

412

Range of Observations (pg/mL)

5-4970

Intercept (pg/mL)

–0.15

Slope

1.00

Correlation Coefficient (r)

0.950

Urinalysis

Quidel | Rapid Diagnostics | quidel.com | 800.874.1517 | 858.552.1100

16 | © Siemens Healthcare Diagnostics Inc., 2016

Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Siemens Stratus CS

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

siemens.com/stratus

Rely on Its Proven Performance The Stratus CS Acute Care Diagnostic System is Designed to Best Fulfill Your Near-patient Setting Needs

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

Siemens Stratus CS

HbA1c and Glucose

Lipid Profile

Near-pat Medline POC Lab with

Without excep Influenza & B / RSV onAtimeliness, with this in mi Point of Care D Strep solution for th Additional POC

Urinalysis

The Stratus® CS Acute Care™ Diagnostic System is the perfect fit for your near-patient testing. Intelligent design guarantees ease of use together with gold-standard quality results. The system provides the necessary biomarkers to cover the spectrum of acute cardiac care.

In a study evaluating the impact of point-of-care testing with cTnI on the Stratus CS Acute Care Diagnostic System versus routine testing, several benefits were documented. With the Stratus CS Acute Care Diagnostic System, turnaround time for near-patient testing was reduced from 76 to 20 minutes. And, total costs associated with point-of-care cTnl testing decreased by 25 percent. Total costs associated with point-of-care cTnI testing decreased

25%

Turnaround time was reduced:

minutes

Routine Testing

to fewer than

2,3

20 minutes

Stratus CS Acute Care Diagnostic System

$20,000

Cost in Per Patient Admission

76

Caring for Patients C

The Benefits of Near-patient Testing2,3

Confidence in near-pa Hematology

• Results in as little as from the central lab

• Less hands-on mani Chemistry

reduces the opportu

• Choose from a robu stratification menu

Immunoassay

Easy to Use by Perso

• Closed whole blood on-board centrifuga

Specialty

• Reduced risk of bioh

• Capability of integra information system

ESR

• No need for daily m $17,163

From “vein to brain”

15,000

$12,882

10,000

Coagulation

5,000

0

Blood Gas

Cardiac Routine Testing

Stratus CS Acute Care Diagnostic System

Collect whole blood samp and enter patient ID (barc or keyboard) LIS/Resources

2

Forms


Lab Portfolio Lab Lead Form

Siemens Stratus CS

HbA1c and Glucose

Lipid Profile

Near-patient Settings with Lab-quality Results

Medline POC

Without exception, acute care depends on timeliness, safety, and effectiveness;1,2 with this in mind, we at Siemens Healthcare Point of Care Diagnostics offer you our solution for the near-patient settings.

Influenza A & B / RSV

Strep

Additional POC

Urinalysis Caring for Patients Comes before Handling Specimens

Laboratory Practices Must Be Perfectly Fulfilled

Confidence in near-patient cardiac marker results

The Stratus CS Acute Care Diagnostic System is designed in compliance with laboratory accrediting agencies (CAP, JCAHO, CLSI), allowing the use of daily system check (Electronic QC) in lieu of daily testing of liquid controls.

• Results in as little as 14 minutes versus 60–120 minutes from the central lab • Less hands-on manipulation than hand-held devices reduces the opportunity for error • Choose from a robust diagnostic and risk stratification menu Easy to Use by Personnel of All Skill Levels

4,5,6,7

• Closed whole blood sample processing using on-board centrifugation • Reduced risk of biohazard

Hematology

Chemistry

• Daily system check with a programmable time lock-out includes: – optical detection system – mechanical alignments – fluid handling system – temperature

Immunoassay

• If required by your institution or local regulations, liquid control check is also available and includes programmable time/range lock-outs.

Specialty

• Capability of integration into your institution’s information system

ESR

• No need for daily maintenance From “vein to brain” in less than 20 minutes.

Blood Gas Coagulation

Cardiac Collect whole blood sample and enter patient ID (barcode or keyboard)

Load sample and test cartridge(s)

Press start

14 minutes later report the first result

LIS/Resources 3

Forms


Lab Portfolio Lab Lead Form

Siemens Stratus CS

HbA1c and Glucose

Stratus Accepta Lipid Profile Interna

Markers You Need That Cover the Spectrum of Acute Cardiac Care

Medline POC Harmonizing the Central Lab and Near-patient Testing “Troponin, CRP, and BNP each provide unique prognostic information in patients with ACS. A simple multimarker strategy that categorizes patients based on the number of elevated biomarkers at presentation allows risk stratification over a broad range of short- and long-term major cardiac events.”2 M.S. Sabatine et al., Circulation 2002

“As more assay systems are devised for point-of-care (POC) testing, identical criteria must apply to both central laboratory methodologies and POC testing systems.”8 Siemens has been proactive in taking steps to ensure the alignment of cardiac Troponin I assays in the central laboratory and near-patient setting. Harmonizing cTnI and NT-proBNP is an increasingly important issue for laboratory medicine.8,9,10 The Stratus CS Acute Care cTnI assay has been shown to demonstrate good agreement across the measurement range with the Siemens central laboratory platforms, the Dimension® RxL Max®, and Xpand® Plus integrated chemistry systems as well as the Dimension Vista® Intelligent Lab System. Siemens offers the only point-of-care/central-lab pair of instruments that demonstrates real cTnI harmony.6,11,12 This also makes Stratus CS Acute Care Diagnostic System a perfect fit as a backup solution in central laboratories and satellite sites.

Guideline Acceptable Troponin I The preferred biomarker for myocardial necrosis8,9 • Meets internationally accepted guidelines (ESC/ACC/AHA/NACB/IFCC)8,9,11 • Excellent sensitivity and cardiac specificity13,14 • 99th percentile of normal: 0.07 ng/mL11,13 • 10% CV at 0.06 ng/mL NT-proBNP 15,16 The aid in evaluating and managing heart failure (HF) and acute coronary syndromes (ACS) • Early and accurate diagnosis • Additional risk factor for poor outcomes in ACS patients Myoglobin8,9 For patients in need of early diagnosis • Excellent negative predictive value rapidly appears in the blood after injury • Usable for reperfusion monitoring and re-infarction

4

CardioPhase® CRP Add to the prediction value of other markers used to assess the risk of cardiovascular and peripheral vascular disease • Inflammation contributing to plaque instability/rupture CKMB mass8,9 The alternative to Troponin I • Usable for re-infarction detection

“We found that a cTnl valu

Influenza A & B / RSV 0.07 ng/mL corresponded

99th percentile of a refer population. A cTnI conce 0.06 ng/mL corresponded Strep imprecision of 10% CV fo independent Stratus CS a routine use. Thus, the 10 the Stratus CS cTnI assay Additional POC the 99th percentile of a r control population, and i with specifications of the redefinition of MI.” 11

Urinalysis

R. Christenson et al., Clin Biochem

Hematology

Chemistry

Immunoassay

Specialty 17

• Estimation of infarct-size14 Additional Assays Available on the Stratus CS Analyzer D-Dimer18,19 An important test performed in patients suspected of thrombotic disorders • High negative predictive value for venous thromboembolism (VTE) • Excludes pulmonary embolism (PE)*

Siemens Acute Ca

The system’s robus

ESR panel provides reli Blood Gas Coagulation

• Excellent sensitivity • High precision at the cut-off level βhCG20 For answering the question of pregnancy quickly and quantitatively to ensure the safest treatment possible

Cardiac

*In conjunction with probability (PTP) as

LIS/Resources **European Society o

American College o

Forms


Lab Portfolio Lab Lead Form

Siemens Stratus CS

HbA1c and Glucose

Stratus CS Acute Care Guideline Acceptable Troponin I Assay Fulfills International Recommendations

Lipid Profile

Medline POC Stratus CS – Cardiac Troponin I – 20 Day Imprecision Study Siemens Healthcare Diagnostics Inc. 0.07 ng/mL – URL 99th Percentile

50

40 30

%CV

“We found that a cTnl value of 0.07 ng/mL corresponded to the 99th percentile of a reference control population. A cTnI concentration of 0.06 ng/mL corresponded to a total imprecision of 10% CV for two independent Stratus CS analyzers in routine use. Thus, the 10% CV for the Stratus CS cTnI assay is below the 99th percentile of a reference control population, and in compliance with specifications of the ESC /ACC ** redefinition of MI.” 11

20

Influenza A & B / RSV

%CV %CV – IFCC data

Strep

IFCC Study21 validates the SCS cTnI precision profile. Pools fell directly on the line. Study lacked sufficient pools between 0.05 –0.20 to accurately identify the 10% CV concentration. The SCS cTnl precision profile more accurately identifies the 10% CV concentration as 0.06 ng/mL11,13

10

Additional POC

Urinalysis

10% CV @ 0.06 ng/mL

R. Christenson et al., Clin Biochem 2004

0

0.0

0.050

0.10

0.15

0.20

0.25

0.30

0.35

0.40

Hematology

Troponin I (ng/mL)

First Guideline Acceptable Troponin I Method

Chemistry

A guideline acceptable Troponin I method is defined by the joint ESC/ASCC committee as having an imprecision level of ≤10% at the 99th percentile of a normal population.8,9,11,21 The assay can be used for the measurement of cardiac Troponin I to aid in the diagnosis of acute myocardial infarction (AMI) and in the risk stratification of patients with acute coronary syndrome (ACS).13

Immunoassay

Specialty Siemens Acute Care Markers The system’s robust and comprehensive cardiac marker panel provides reliable answers to critical questions.

ESR Blood Gas Coagulation

Cardiac *In conjunction with a non-high clinical pretest probability (PTP) assessment model

**European Society of Cardiology American College of Cardiology

LIS/Resources 5

Forms


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Siemens Stratus CS

HbA1c and Glucose

Stratus CS Acute Care System Designed for Acute Care Diagnostics

Lipid Profile

System, Sample, and Reagent Specifications Troponin-I

CKMB

NT-proBNP

D-dimer

hsCRP

Myoglobin

βhCG

Assay Range

0.03–50 ng/mL (mg/L)

0.3–150 ng/mL (mg/L)

15–20000 pg/mL

6 –5000 ng/mL (mg/L) FEU

0.1–50 mg/L

1–900 ng/mL (mg/L)

0.5–1250 mIU/mL (IU/L)

Sensitivity

0.03 ng/mL

0.3 ng/mL

15.0 pg/mL

6.0 ng/mL

0.1 mg/L

1.0 ng/mL

0.5 mIU/mL

Reproducibility (C V)

5.1% at 0.64 ng/mL 10% at 0.06 ng/mL

4.0% at 3.7 ng/mL

4.4% at 96.6 pg/mL

4.1% at 412 ng/mL

6.8% at 1.16 mg/L

3.4% at 56 ng/mL

2.6% at 5.1 mIU/mL

Please refer to the assay insert sheets or operator’s guide for more detailed information.

Automatic Alignment Level-sensing capabilities automatically align to each TestPak and module Computer Interface Specifications Uni-directional Environmental Specifications Room Temperature: 17–30°C Humidity: 20–80% Waste Disposal All hazardous materials are contained within a disposable waste liner Centrifuge Speed Microprocessor-verified between 18,000 and 22,000 rpm Sample and TestPak Identification Universal barcode reader Automatic Dilutions Single-use DilPaks per method Real-Time Fluid Management Liquid level sensing capability combined with fluidic dispense monitoring system Turnaround Time System provides first result in as little as 14 min and a panel of 4 tests in 26 min from a whole blood sample Specimen Type Sodium heparin or lithium heparin for all methods except D-dimer. Please refer to assay product inserts for more detailed information. D-dimer requires lithium heparin or sodium citrate whole blood or plasma.

Quality Control • Daily system check (electronic QC) with programmable time lockout • Liquid controls are processed after calibration, upon receipt of a previously calibrated lot of reagents or whenever the site wishes to verify performance, and according to local, state, and/or federal regulations • On-board “QC Required” alert for a time element and/or range check Software Features • The last 20 results are stored and can be reprinted and/or transmitted to LIS • Patient ID and/or sample ID entry sample collection time entry • Unauthorized operator lockout capability • TestPak lot expiration notification password protection of advanced setup functions • POC interface mode for connectivity Storage Requirements TestPaks, CalPaks, and DilPaks: 2 to 8°C (Troponin-I CalPak and NT-proBNP CalPak: -10 to -20°C) Calibration Stability • 90 days for βhCG • 60 days for cTnI, CKMB, Myoglobin, D-dimer, and hsCRP

Catalog No.

SMN#

CCTNI 10445071 Influenza A & B / RSV CCTNI-CR

10445072

CCTNI-D

10445073

CCKMB Strep

10445068

CCKMB-C

10445069

CCKMB-D

10445070

CPBNPM POC10445086 Additional CPBNPM-C

10445087

CPBNP-D

10445085

CDDMRE Urinalysis

10701511

CDDMR-C

10445076

CDDMR-D

10445077

CCCRP Hematology

10445066

CCCRP-C

10445067

CMYO

10445079

CMYO-C Chemistry

10445080

CMYO-D

10445081

CBHCG

10445060

CBHCG-C 10445061 Immunoassay CBHCG-D

10445062

CROTOR

10445088

CCANBD Specialty

10445063

CCANS

10445064

CCUPS

10445074

CPAPER

ESR

10445082

CTIPS

10445089

CLINER

10445078

Blood Gas Coagulation

• 30 days for NT-proBNP Calibration Up to 3 separate TestPak lots per assay can be stored Reagent Capacity Single-use assay cartridges Assay Technology Dendrimer enhanced radial partition immunoassay

6

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Lab Portfolio Lab Lead Form

Siemens Stratus CS

HbA1c and Glucose

Lipid Profile

Ordering Information Catalog No.

SMN#

Product Description

Quantity

CCTNI

10445071

Stratus CS Acute Care Troponin I TestPak

CCTNI-CR

10445072

Stratus CS Acute Care cTnI CalPak

5

CCTNI-D

10445073

Stratus CS Acute Care cTnI DilPak

5

CCKMB

10445068

Stratus CS Acute Care CKMB TestPak

CCKMB-C

10445069

Stratus CS Acute Care CKMB CalPak

5

CCKMB-D

10445070

Stratus CS Acute Care CKMB DilPak

5

CPBNPM

10445086

Stratus CS Acute Care pBNP TestPak

CPBNPM-C

10445087

Stratus CS Acute Care pBNP CalPak

5

CPBNP-D

10445085

Stratus CS Acute Care pBNP DilPak

5

CDDMRE

10701511

Stratus CS Acute Care D-Dimer TestPak

CDDMR-C

10445076

Stratus CS Acute Care DDMR CalPak

5

CDDMR-D

10445077

Stratus CS Acute Care DDMR DilPak

5

CCCRP

10445066

Stratus CS Acute Care CCRP TestPak

60

CCCRP-C

10445067

Stratus CS Acute Care CCRP CalPak

5

CMYO

10445079

Stratus CS Acute Care Myoglobin TestPak

CMYO-C

10445080

Stratus CS Acute Care MYO CalPak

5

CMYO-D

10445081

Stratus CS Acute Care MYO DilPak

5

CBHCG

10445060

Stratus CS Acute Care βhCG TestPak

CBHCG-C

10445061

Stratus CS Acute Care βhCG CalPak

5

CBHCG-D

10445062

Stratus CS Acute Care βhCG DilPak

5

CROTOR

10445088

Centrifuge Rotor

100

CCANBD

10445063

BD Vacutainer Cannula Adapter

100

CCANS

10445064

Sarstedt Cannula Adapter

100

CCUPS

10445074

Sample Cups

100

CPAPER

10445082

Thermal Printer Paper

CTIPS

10445089

Pipette Tips

CLINER

10445078

Waste Container

®

®

100

100

100

60

100

100

10 1,920

References: 1. Hamm C, et al. N Engl J Med. 1997;337(23):1648-53 2. Sabatine MS, et al. Circulation 2002;105:1760-63 3. Casagranda I, et al. Clinica Chimica Acta 2001;311:63-66 4. Altinier S, et al. Clinica Chimica Acta 2001;311:67-72 5. Walker T, et al. Am Clin Lab 2001;37-39 6. Gantzer, ML, et al. Poster Presentation AACC 2002. Clin Chem 2002;48(6) 7. Bauer R, et al. Point of Care 2002;1(1):54-57 8. NACB and IFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine Practice. Guidelines: Analytical Issues for Biochemical Markers of Acute Coronary Syndromes. Clin Chem 2007;53:547-551 and Circulation 2007;115:352-355 9. ESC/ACC Joint Committee – J Am Coll Cardiol 2000;36:959-69 Eur Heart J 2000;21:1502–13, Clin Chem 2001;47:382–92 10. Collinson P. Global Perspective: Managing Cardiovascular Disease (Educational Video/CD-ROM) 11. Christenson R, et al. Clin Biochem 2004;37:679-683 12. Kim WJ, et al. Clin Chem 2002;48(7):1028-34 13. Stratus CS cTnI TestPak (product insert). 14. NACB Laboratory Medicine Practice Guidelines: Clinical Characteristics and Utilization of Biochemical Markers in Acute Coronary Syndromes. Clin Chem 2007;53:552-574 15. Mueller T, et al. N Engl J Med. 2004;350(7):647-654 16. Januzzi JL, van Kimmenade R, et al. Eur Heart J Advance Access, November 17, 2005 17. Braunwald E, et. al. Circulation 2000;102:1193-1209 18. Engelhardt W, et al. Thromb Res. 2004,112,25-32 19. Reber G, et al. Blood Coagul and Fibrinolysis, 15(5),2004. 20. Di Serio F, et al. Poster Presentation, 20th Intl Symposium on Critical Care and POCT. Wuerzburg, 2004 21. Panteghini M, et al. Clin Chem 2004;50(2): 327-32

Medline POC Influenza A & B / RSV

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Lab Portfolio Siemens Stratus CS

Lab Lead Form HbA1c and Glucose

Acute Care, CardioPhase, Dimension, Dimension Vista, Xpand, RxL Max, Stratus, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

Lipid Profile

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Immunoassay Local Contact Information Siemens Healthcare Point of Care Diagnostics 2 Edgewater Drive Norwood, MA 02062-4637 USA Telephone: +1 781-269-3000 siemens.com/healthcare

Specialty

ESR

siemens.com/ Blood Gas

Siemens Healthcare Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Phone: +49 9131 84-0 siemens.com/healthcare

Rely o

Coagulation The Stratus C

to Best Fulfill

Cardiac Cardiac LIS/Resources

Order No. A91DX-POC-151691-GC1-4A00 | 02-2016 | © Siemens Healthcare Diagnostics Inc., 2016

siemens.com/healthcare

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Quidel Triage BNP ALR98000XR | 25ea/bx L20.32.31.15.68 83880QW $39.26

Placement Agreement

ST9800000EN00.qxp_Layout 1 2/22/18 7:23 AM Page 1 Quidel Triage

Lab Lead Form HbA1c and Glucose

Lipid Profile

One test. Multiple platforms. Dependable results. Access® 2* Immunoassay System

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Urinalysis

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Quidel Triage System

Immunoassay

Clinically Interchangeable BNP Results Regardless of Platform1 n

Method comparison of BNP assay results obtained using the Triage Meter versus the Triage BNP assay for Beckman Coulter Immunoassay Systems–BNP measurements of 412 EDTA plasma samples using the Triage BNP testing platforms. A Passing-Bablock regression analysis was applied.

412

Range of Observations (pg/mL)

ESR Blood Gas

5-4970

Intercept (pg/mL)

–0.15

Slope

1.00

Correlation Coefficient (r)

Specialty

Coagulation Cardiac

0.950

LIS/Resources Quidel | Rapid Diagnostics | quidel.com | 800.874.1517 | 858.552.1100

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Lab Portfolio

Quidel Triage BNP ALR98000XR | 25ea/bx L20.32.31.15.68 83880QW $39.26

Placement Agreement

Quidel Triage

ST9800000EN00.qxp_Layout 1 2/22/18 7:23 AM Page 2

Lab Lead Form HbA1c and Glucose

Why Triage BNP? B-type natriuretic peptide (BNP) is a naturally secreted hormone released primarily from cardiac

Lipid Profile

myocytes in response to ventricular volume expansion and pressure overload.

1

Add whole blood sample to Triage BNP Test using transfer pipette

2

Insert test panel into Triage Meter.

included in each kit.

3

Medline POC

Read results on screen, or press “Print” for a hard copy. Complete in

Influenza A & B / RSV

approximately 15 minutes.

Strep

Additional POC Urinalysis

Test results are available in approximately 15 minutes (just 2 minutes of hands-on time).

Triage BNP Test indications

BNP is an excellent hormonal marker of ventricular systolic and diastolic dysfunction.2

To aid in the diagnosis of heart failure

When used in conjunction with other clinical information, BNP levels may help risk stratify ACS patients for hospital admission or direct ED discharge.3

To risk stratify patients with acute coronary syndromes

BNP levels at the time of admission are powerful predictors of outcomes in predicting death and rehospitalization of heart failure patients.4 BNP levels have been shown to reduce time to adequate therapy, the need for hospitalization and intensive care admission, length of stay, and the mean total cost of treatment.5 CLIA waived for whole blood.

To assess the severity of heart failure To risk stratify patients with heart failure

Hematology Chemistry

Immunoassay

How accurate is the Triage BNP Test The Triage BNP Test has 98 percent specificity using a 100 pg/mL cutoff.6 In initial studies, the Triage BNP Test provided 98 percent diagnostic accuracy versus all other clinical findings in patients with or without disease history and corrected 96 percent of misdiagnoses of patients with suspected heart failure.7

Specialty

ESR Blood Gas

Access® and Unicel® are trademarks of Beckman Coulter Inc. 1 Triage BNP Panel [product insert]. San Diego, CA: Alere Inc.; 2016. 2 Wilkins MR, Redondo J, Brown LA. The natriuretic-peptide family. Lancet. 1997;349(9061): 1307-1310. 3 Maisel A, Mueller C, Adams K Jr, et al. State of the art: using natriuretic peptide levels in clinical practice. Eur J Heart Fail. 2008;10(9):824-839. 4 Fonarow GC, Peacock WF, Phillips CO, Givertz MM, Lopatin M, ADHERE Scientific Advisory Committee and Investigators. Admission B-type natriuretic peptide levels and in-hospital mortality in acute decompensated heart failure. J Am Coll Cardiol. 2007;49(19):1943-1950. 5 Mueller C, Scholer A, Laule-Kilian K, et al. Use of B-type natriuretic peptide in the evaluation and management of acute dyspnea. N Engl J Med. 2004;350(7):647-654. 6 Triage BNP [package insert]. San Diego, CA: Alere, Inc.; 2015. 7 Dao Q, Krishnaswamy P, Kazanegra R, et al. Utility of B-type natriuretic peptide in the diagnosis of congestive heart failure in an urgent-care setting. J Am Coll Cardiol. 2001;37(2):379-385.

Triage BNP Test – 15 Test Kit: Catalog #98010XR Triage BNP Test – 25 Test Kit: Catalog #98000XR Triage BNP Control 1 – 5 x 0.25 mL Vials: Catalog #98013XR Triage BNP Control 2 – 5 x 0.25 mL Vials: Catalog #98014XR Triage BNP Calibration Verification – 5 x 5 Levels: Catalog #98015XR

Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems

Coagulation Cardiac

SL2702 | ST98000000EN00 (02/18)

Triage BNP Reagent Packs – 2 x 50 Tests: Catalog #98200 Triage BNP QC Controls – 2 x 3 Levels: Catalog #98201 Triage BNP Calibrators – 1 x 6 Levels: Catalog #98202

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Lab Portfolio Lab Lead Form HbA1c and Glucose

LIS/Resources Assurity Labs

CGM LABDAQ LIS Solutions

Medicus LIS

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Doctors Management Consulting

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CGM LABDAQ Laboratory Information System

YOUR OWN LAB IS THE BEST LAB

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CONSULTING INSTRUMENTS AND SOFTWARE LABOR AND STAFF EDUCATION FINANCIAL CLINICAL AND TECH SUPPORT

PLAN-A LABS

  

CGM LABDAQ

  

SOLUTIONS

Additional POC

COMPUGROUP MEDICAL’S Laboratory Division has the LIS solution for any facility performing laboratory testing

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Lighthouse Lab Services Lighthouse’s Moderate Complexity Upgrade Ma ageme t Program Allow our experts to guide you through the process o upgr di g your l or tory ro : CLIA WAIVED STATUS

MODERATE COMPLEXITY

Chemistry

Immunoassay

PROGRAM S R " S "L : Providing a fully qualified Moderate Complexity Lab Director and Technical Consultant in accordance with your state’s regulations

Creating Ps + reviewing and updating those procedures on an ongoing basis using our cloud-based document management system

Quarterly on-site visits and up to 6 hours of additional remote work per month

Generating the initial CL and state applications + on-site for all prescheduled inspections

Specialty

Lighthouse L Services, LL". www.lighthouselabservices.com

start@lighthouselabservices.com

(800) 838-0602

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HbA1c and Glucose

YOUR OWN LAB IS THE BEST LAB

CONSULTING

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INSTRUMENTS AND SOFTWARE LABOR AND STAFF EDUCATION FINANCIAL CLINICAL AND TECH SUPPORT

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PLAN-A LABS

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AL

ASSURITY LABS PLAN-A

The All Inclusive Program > TURNKEYB

As hands on or hands off as you want to be > FROM SET UP TO BILLING An accurately represented prospectus and ROI scenario is critical to determining the economic and compliance impact of your lab on your practice. Our team will meet with you to discuss the critical details of your practice including: Sample volumes, types of samples, payer mix, space requirements, etc. This will best determine your laboratory needs and returns.

> SCALED TO YOUR SCOPE OF CARE Plan-A gives you a team of implementation professionals including integrated peer consultants, compliance experts, laboratory technicians, renowned capital equipment manufacturers, and information system providers. This ensures the highest quality and fastest ROI in the industry. Your business is unique and must be ideally configured for you.

> C O N S U LT I N G We will provide you with all necessary elements for operating your high complexity lab. Included in Plan-A will be your director and licensed lab technician. Your office staff will be trained on your state of the art tech and process integration to ensure that your lab is optimized to your goals.

> FINANCIAL, CLINICAL, TECHNICAL An accurately represented prospectus and ROI scenario is critical to determining the economic and compliance impact of your lab on your practice. Our team will meet with you to discuss the critical details of your practice including: Sample volumes, types of samples, payer mix, space requirements, etc. This will best determine your laboratory needs and returns.

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THE PROCESS

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1 Phase 1 (Days 1-5)

Consultation and Agrement Full understanding of the requirements for your program (Licensing, TI requirements, and Compliance)

2

3

Phase 2 (Days 1-5)

Phase 3 (Days 30-60)

Your lab collection on technician is placed into your facility and begins to understand your work flow needs.

Assurity purchases the equipment and hires your lab director and lab scientist

Transition Planning

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4 Phase 4 (Days 30-60)

5

6

Compliance Program Installed

Phase 5 (Days 60-90)

Hardware and Software Installed

Phase 6 (Day 90+)

Licensure and CLIA change application

Equipment installation and Validation

Final Lab Inspection. Lab fully operational and profit streams commence

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Operations Commence

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Lab Portfolio CGM LABDAQ LIS Solutions

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CGM LABDAQ Laboratory Information System

HbA1c and Glucose

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CGM LABDAQ

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SOLUTIONS

Chemistry

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COMPUGROUP MEDICAL’S Laboratory Division has the LIS

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solution for any facility performing laboratory testing

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THE POWER OF CGM LABDAQ

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The CGM LABDAQ LIS

CGM LABDAQ® LABORATORY INFORMATION SYSTEM (LIS) IS A TRUSTED SYSTEM USED

family of products will

BY THOUSANDS OF LABORATORY PROFESSIONALS EVERY DAY. CGM LABDAQ CAN BE FOUND IN VIRTUALLY EVERY CLINICAL LABORATORY ENVIRONMENT INCLUDING REFERENCE LABS, DRUG LABS, PHYSICIAN OFFICE LABS, CLINICS AND HOSPITALS.

throughout any facility that performs laboratory testing. The scalable software solutions will automate manual processes while increasing reimbursements and efficiencies.

Strep

CGM LABDAQ PROVIDES:

MAXIMIZED REIMBURSEMENTS

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There are various tools built into CGM LABDAQ that ensure laboratory tests are billed correctly. User defined rules will ensure that all testing and billing procedures are tracked and enforced, assisting with accurate and timely payment to your facility.

Urinalysis

TOTAL CONNECTIVITY CGM LABDAQ LIS provides real-time access to all necessary parties outside the laboratory. Interfaces with your EHR and practice management system (orders, demographics, results and billing information) provide your practice with total connectivity. Bi-directional interfaces to national and regional reference laboratories are also available.

INCREASED PATIENT SAFETY Patient care is of the highest importance for all healthcare professionals. CGM LABDAQ improves efficiency while reducing errors ensuring results are precise, accurate and available to providers as quickly as possible.

IMPROVED WORKFLOW CGM LABDAQ is easily configured to fit into your facility’s unique environment. The LIS will automate pre-analytic, analytic and post-analytic activities, eliminating tedious manual entry and reducing the possibility of human error.

REGULATORY AND HIPAA COMPLIANCE CompuGroup Medical works closely with regulatory agencies to provide the required tools to assist with compliance. CGM LABDAQ has an established record of updating software to meet new regulations. Laboratory inspections require less preparation with CGM LABDAQ’s Quality Control module and user defined rules ensure that laboratory procedures are followed.

DATA INTEGRITY AND SECURITY CGM LABDAQ is built on the most trusted name in database technology, Oracle. The Oracle database provides optimum data storage, security and performance.

Hematology © Copyright 2017 CompuGroup Medical, Inc. All rights reserved.

improve operations

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TOTAL CONNECTIVITY

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CGM LABDAQ rapidly processes orders and disseminates results, providing the ability to effectively share data throughout your facility. Reference laboratories can also directly interface with client EHR systems. CGM LABDAQ’s dedicated systems integration department ensures any interface your organization requires will be completed efficiently. •

Laboratory Analyzers

Electronic Health Records (EHR)

Hospital Information Systems (HIS)

National and Regional Reference Laboratories

Laboratory Outreach Systems

State Health Departments

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© Copyright 2017 CompuGroup Medical, Inc. All rights reserved.

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CGM LABDAQ POL CGM LABDAQ POL is a solution designed for low volume physician office laboratories that includes the basic functionality of CGM LABDAQ LIS without the complexities required in a high volume laboratory. Many practices have considered purchasing an LIS but the systems were cost prohibitive; CGM LABDAQ POL is the affordable solution. The ability to expand to the full CGM LABDAQ LIS is available as the practice grows and the laboratory requires additional functionality.

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CGM LABDAQ

GET AUTOMATED WITH CGM LABDAQ

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THE FEATURES AVAILABLE IN THE CGM LABDAQ® FAMILY OF PRODUCTS INCLUDE:

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CGM LABDAQ LIS

CGM LABDAQ POL

Unlimited

Up to 4

Quality Control

a

a

Manual Batch Entry of Test Results

a

a

Tools to Support HIPAA and CLIA Compliance

a

a

Workflow Management - Open Windows Architecture

a

a

Rules Engine

a

Available Option

Standing Orders

a

-

FEATURE QUANTITY INCLUDED: Workstations

Strep

FUNCTIONALITY:

Additional POC

Urinalysis Hematology

Pending Panel Reports

a

a

Testing Volume Reports

a

a

Billing Reports

a

a

Turn Around Time Reports

a

a

Corrective Action Report

a

a

Levey-Jennings Chart/Control Graph Studies

a

a

CGM DAQcounter™

a

a

Barcode Label Printing

a

a

Email

a

a

AutoFAX

a

a

Interfaces to EHR/Billing Systems

a

a

Interfaces to Reference Laboratories

a

a

Medical Necessity Software including ABN

a

a

Management Review

a

a

Medication Compliance

a

-

Data Miner

a

-

Client Services

a

-

Microbiology Module

a

-

Scanning/Attachments

a

-

Workflow Management

a

-

LAB IQ

a

-

AVAILABLE OPTIONS:

© Copyright 2017 CompuGroup Medical, Inc. All rights reserved.

AVAILABLE REPORTS:

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Forms


Lab Portfolio Doctors Management Consulting

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources

Forms


Lab Portfolio Doctors Management Consulting

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac

LIS/Resources Forms


Lab Portfolio Lighthouse Lab Services

Lab Lead Form HbA1c and Glucose

Lighthouse’s Moderate Complexity Upgrade Ma ageme t Program Allow our experts to guide you through the process o upgr di g your l or tory ro : CLIA WAIVED STATUS

MODERATE COMPLEXITY

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

PROGRAM S R " S "L : Providing a fully qualified Moderate Complexity Lab Director and Technical Consultant in accordance with your state’s regulations

Creating Ps + reviewing and updating those procedures on an ongoing basis using our cloud-based document management system

Quarterly on-site visits and up to 6 hours of additional remote work per month

Generating the initial CL and state applications + on-site for all prescheduled inspections

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac

LIS/Resources

Lighthouse L Services, LL". www.lighthouselabservices.com

start@lighthouselabservices.com

(800) 838-0602

Forms


Lab Portfolio Lab Lead Form HbA1c and Glucose

Forms Medline Lab Information

Lipid Profile

Medline POC

CPT Code Sheet

Medline Lab Information Form

Highly Moderate Waived None

Account Name: ___________________________________________________________________________________________ Account Number: _____________________________ Address: ____________________________________________________________________ City, State, ZIP: ______________________________________________________________

3 months 6Immediate 12 months

Immunoassay:

Weekly:

$13.39 $8.61

Fecal Occult Guiaic

82270

Mono

86308QW

$16.53 $35.09

Influenza A/B

87804QW x 2

$33.10

87502QW

$95.80

RSV

87807QW

$13.10

Influenza A + B/RSV Molecular

87631QW

$142.63

H. Pylori

86318QW

$18.09

HIV

86703

$13.71

TSH

84443QW

$16.80

Bacterial Vaginosis

87905QW

$12.22

Syphilis (Treponema Pallidum) Trichomonas

Please list test volumes: CMP: __________________ BMP: __________________ Lipids: __________________ Hepatic: __________________ Renal: __________________ DOA: __________________ CBC: ___________________ TSH: ___________________ PSA: ___________________ VIT D: ___________________ B12: ___________________ FOLATE: ___________________ Ferritin: _________________ Testo: _________________ T3: _________________ T4: _________________ Prolactin: _________________ Progesterone: _________________

86780QW

$13.24

87808QW

$15.29

DOA

80305

$12.60

Hemoglobin

85018QW

$2.37

PT/INR

85610QW

$4.29

Urinanalysis, automated, without microscopy Urinalysis non-automated, without microscopy Multistix PRO Albumin w/ Creatinine

Others: _______________________________________________________________________________________________________________________________________________________

ACCOUNT PAYER MIX Private Pay: _______________ Medicare: _______________ Insurance: _______________ HMO: _______________ Medicaid: _______________ Other: _______________ Fill in above with % of patients covered—the total should be 100%

81003QW

Immunoassay ___ Vitamin D ___ TSH ___ FT3 ___ F4

Community Health Centers Point-of-Care

$7.43 $11.41

83655QW

$12.11

Notes/Comments: __________________________________________________________________________________________________________________________________________

___ CMP ___ BNP

$3.48

82044QW & 82570QW

Lead

________________________________________________________________________________________________________________________________________________________________

Chemistry

$2.25

81002 81003QW & 82570QW

Microalbumin w/ Creatinine

Current Systems: __________________________________________________________ Current Ref Lab: _____________________________________________________________

Point-of-Care

___ BNP (Triage) Tests ___ Cholesterol (Lipids) Tests ___ PT/INR Tests

$5.18

87880QW 87651QW

Other:

Daily:

Cardiology

$4.38

Strep A Rapid Strep A Molecular Influenza A + B Molecular

Rent Own Lease

Chemistry:

80061QW

$15.92

Please check the time range for volumes: Monthly:

$3.28

81025QW

Please check the discipline where there is an opportunity:

Yearly:

82962

82274QW or G0328QW

IDN: __________________________________ GPO: __________________________________ LIS: __________________________________ EMR: __________________________________

Hematology:

Glucose Pregnancy

Phone #: ________________________________________ Type of Practice: _________________________________________________________________________________________

Purchase Timeframe (choose one):

$9.71 $3.93

Lipid Profile

Technical Buyer Name: ____________________________________________________ Email: _________________________________________________________________________

Date:

Lab Products for Physician’s Office Specialty

Medicare Reimbursement:

83036QW 82947QW

Fecal Occult Immunoassay (iFOBT)

Financial Buyer Name: ____________________________________________________ Email: _________________________________________________________________________

Purchase Preference (choose one):

CPT Code:

HbA1C Glucose - Hemocue

BNP

83880QW

$39.26

CMP (waived)

80053QW

$10.56

Lyme

86618QW & 86618QW-59

$34.06

Division Manager: __________________________________________________________ Lab Capital Specialist: _______________________________________________________

Endocrinology Point-of-Care

___ Blood Glucose Tests ___ Hemoglobin A1c Tests ___ Urinalysis Tests ___ Microalbumin Tests

Hematology

___ CBC-3 part diff

Chemistry

Hematology

___ FSH ___ LH ___ Prolactin ___ Progesterone ___ Estradiol ___ TSH ___ BhCG ___ DHEA ___ AMH

Chemistry ___ CMP ___ BMP

© 2020 Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc. 19W694762 / e20056 / 19

Coag-Sense Meter Agreement

Sexual Health

___ Bacterial Vaginosis Tests ___ Chlamydia Tests ___ Gonorrhea Tests ___ Herpes Tests ___ HIV Tests ___ Trichomonas Tests

___ Allergy Tests ___ Blood Glucose Tests ___ BNP (Triage) Tests ___ C-Diff Tests ___ Cholesterol (Lipids) Tests ___ Drugs of Abuse Tests ___ Fecal Occult Blood Tests (iFOBT) ___ Fecal Occult Blood Tests (Guaiac) ___ Hemoglobin Tests ___ Hemoglobin A1c Tests ___ H. pylori Tests ___ Influenza A&B Tests ___ Lead Tests ___ Microalbumin Tests ___ Mono Tests ___ Pregnancy Tests ___ PT/INR Tests ___ RSV Tests ___ Strep A Tests ___ Thyroid (TSH) Tests ___ Urinalysis Tests ___ CBC-3 part diff

All information provided here is most recent as of January 2020 obtained from: https://www.cms.gov/apps/ama/license.asp?file=/Medicare/Medicare-Fee-for-ServicePayment/ClinicalLabFeeSched/Downloads/20CLABQ1.zip It is always the provider's responsibility to determine appropriate coding, claims, and charges for a procedure

Rep Name: _________________________________________________________________ Rep Number: _________________________________________________________________

Strep

Medline Account Number:

For your convenience, here is a summary of commonly performed CLIA-WAIVED lab tests. Please see your Medline representative for pricing and for information on products not seen here.

Procedure:

Influenza A & B / RSV

EVENCARE Meter Agreement

Rep Name - Title (555) 555-1234 Lab Products –National Reimbursement & Coding for 2020

Date: ____________________________________________ Facility’s current CLIA complexity level (choose one):

PO Lab Ordering Checklist By Specialty

___ CMP ___ Hemoglobin A1c Tests

Immunoassay

___ TSH ___ FT3 ___ FT4 ___ Vitamin D ___ Testosterone ___ Thyroglobulin ___ Thyroglobulin Antibody ___ Prolactin ___ Estradiol ___ FSH ___ LH ___ Folate ___ Cortisol ___ SHBG

Fertility

Immunoassay

Imaging

Point-of-Care

___ Pregnancy

Chemistry

___ Creatinine

Internal Med/Family Practice Point-of-Care

___ Allergy Tests ___ Blood Glucose Tests ___ BNP (Triage) Tests ___ C-Diff Tests ___ Cholesterol (Lipids) Tests ___ Drugs of Abuse Tests ___ Fecal Occult Blood Tests (iFOBT) ___ Fecal Occult Blood Tests (Guaiac) ___ Hemoglobin Tests ___ Hemoglobin A1c Tests ___ H. pylori Tests ___ Influenza A&B Tests ___ Lead Tests ___ Microalbumin Tests ___ Mono Tests ___ Pregnancy Tests ___ PT/INR Tests ___ RSV Tests ___ Strep A Tests ___ Thyroid (TSH) Tests ___ Urinalysis Tests

Customer has agreed to purchase glucose test strips from Medline. Medline and Customer acknowledge the EVENCARE test strips cannot be read without the respective EVENCARE glucose meter. Medline agrees to supply the EVENCARE meters in the quantities indicated for Customer’s own use at no additional cost to Customer. This agreement is valid for five years from the date of execution.

By completing and signing below, Customer acknowledges and agrees that any meter provided by Medline hereunder shall not be claimed as a reimbursable expense or reflected as a reimbursable expense on any cost report under any federal or state health program.

Item

Additional POC

(Approved for Single Patient Use and Multi-Patient Use)

EVENCARE G3 Glucose Meter

MPH3540

(Approved for Multi-Patient Use Only)

EVENCARE ProView Glucose Meter

MPH4540

___ CBC-3 part diff

Estimated Annual Quantity Needed

Description

EVENCARE G2 Glucose Meter

MPH1540

Hematology

(Approved for Multi-Patient Use Only)

MPH5540

EVENCARE Mini Glucose Meter

MPH6540

EVENCARE Harmony Glucose Meter

(Approved for Single Patient Use Only)

Chemistry ___ CMP ___ BMP

Immunoassay ___ Vitamin D ___ TSH ___ FT3 ___ FT4 ___ PSA

Sexual Health

(Approved for Multi-Patient Use Only)

Urinalysis

Authorized Signature: Print Name/Title:

___ Bacterial Vaginosis Tests ___ Chlamydia Tests ___ Gonorrhea Tests ___ Herpes Tests ___ HIV Tests ___ Trichomonas Tests

Magellan LeadCare II Placement Program

Alere Cholestech LDX Placement Agreement

EVENCARE Meter Agreement

Please fax this agreement to 847-643-3455 before ordering meters and test strips.

Quidel Triage Placement Agreement

Medline Account Number: ________________

Valid: 01/1/20 – 12/31/20

Medline Sales Rep: ______________________ #: ________ Begin Date: _____ / _____ / _________

Medline Account Number:___________________________ Date:___________________________

Placement Program

Alere Cholestech LDX® System Placement Agreement

FAX COMPLETED FORM IMMEDIATELY TO MEDLINE DIAGNOSTICS AT 1-847-643-3338

Customer has agreed to purchase the Coag-Sense PT/INR system from Medline. Medline and Customer acknowledge the Coag-Sense test strips cannot be read without the respective Coag-Sense meter. Medline agrees to supply the Coag-Sense meter at a discounted rate in the associated packages.

Purchase four (4) LeadCare® II Test Kits, and Commit to purchase eight (8) test kits annually (384 tests). (The initial four-kit purchase counts toward the first year’s eight-kit

Any reference to “Placement” or “Agreement” shall mean this document and any and all schedules or addenda attached at any time hereto.

commitment.)

This Agreement enables the Customer to purchase the Products identified below in the indicated quantities and at the indicated prices, and qualify for the use, service and upgrades of the Alere Cholestech LDX System (“Equipment”) indicated in the first point of this Agreement at no charge.

3 Box Promo and 5 Box Promo

Item

Description

ABO06F2303 ABO06F2364

1. Minimum Commitment

Promo Price

Q: Is this a “rent-to-own” program?

Medline will supply one Alere Cholestech LDX System (“Equipment”) at no additional cost to Customer for a commitment to purchase a total of 120 boxes of the selected Product(s) listed below over the next 24 calendar months upon receipt of the Equipment.

Coag-Sense 3 Box Promo

(Contains 50 test strips, 4 control strips and 54 transfer tubes per box, and meter)

Coag-Sense 5 Box Promo

A: No. Meridian Bioscience will own the analyzer for as long as the agreement is in effect. The analyzer will be covered under warranty as long as the agreement is in effect.

(Contains 50 test strips, 4 control strips and 54 transfer tubes per box, and meter)

Q: What happens if we have more than one location? A: Great! Meridian Bioscience is interested in supporting testing at all customer locations. Contact us for more information about using LeadCare® II at multiple sites.

Medline agrees to reconcile the test kit purchases with Customer once a year. Based on this reconciliation, Medline will confirm the number of boxes of strips purchased by Customer and will provide Customer with a purchase summary.

By completing and signing below, Customer acknowledges and agrees that any meter provided by Medline hereunder shall not be claimed as a reimbursable expense or reflected as a reimbursable expense on any cost report under any federal or state health program.

Q: What happens if the purchase commitment is not met? A: If the customer stops testing, or does not meet the purchase commitment, Meridian Bioscience will contact the customer for the return of the analyzer from the customer’s facility.

Alere Cholestech LDX® Meter Placement Agreement (MPA) Customer Commitments: Product Commitment – Check One:

Authorized Signature: ______________________________________________________________ Print Name/Title: __________________________________________________________________

Lipid-Glucose (Alere #10-991)

_______

Lipid

(Alere #10-989)

Medline # CHLS10991 Medline # CHLS10989

Price $ ____________

Medline # CHLS10990

Price $ ____________

TC/HDL

Medline # CHLS10987

Price $ ____________

(Alere #10-987) _______

Q: What do I do next?

Price $ ____________

_______

TC/HDL/GLU (Alere #10-990) _______

A: Customer and sales representative sign the Placement Program Agreement, certifying that each understands the commitment, and that the customer has sufficient volume to use at least the minimum required number of kits (8/year).

Implementation Pack – (One-time Purchase Commitment) – Check One: Alere Cholestech LDX® System must ship with one of the following Implementation Packs, please select one:

Please fax this agreement to 847-643-3455 before ordering meters and test strips.

Lipid-Glucose (Alere #14-205) _______

Medline # CHLS14205

Price $ 401.00

Lipid

(Alere #14-206) _______

Medline # CHLS14206

Price $ 365.00

TC/HDL/GLU (Alere #14-207) _______

Medline # CHLS14207

Price $ 320.00

TC/HDL

Medline # CHLS14208

Price $ 290.00

(Alere #14-208) _______

Distributor Rep

Deliver the signed agreement and a purchase order for the promotion code to your sales representative for processing. The analyzer and four test kits will be drop shipped from Meridian Bioscience directly to the customer. Contact: LeadCare Sales 1-800-305-0197 LeadCareSales@meridianbioscience.com www.meridianbioscience.com

The above “Implementation Packs” include the Alere Cholestech LDX® System, Printer, One (1) Box of Controls, “starter” supply pack and Three (3) Boxes of selected “Test”.

© 2020 All rights reserved. LeadCare is a registered trademark of Meridian Bioscience. All other trademarks belong to their respective owners. MBI_LC_II_Placement_Contract_Medline_2019-12

Distributor Account #

NATURE OF THE AGREEMENT. Quidel desires to sell to Customer and Customer desires to purchase from Quidel or its authorized distributor, as designated, (“Distributor”) certain tests used with the Triage Meter(s) (“Consumables”), as described herein. In addition, Quidel desires to provide to Customer, and Customer desires to use, Triage Meter(s) and ancillary components (the “Equipment”) for use with the Consumables during the Term of the Agreement (the “Equipment Use”). Title to the Equipment will remain with Quidel. For purposes of this Agreement, Consumables and Equipment (or Equipment Use), are collectively referred to as “Product” or “Products.” AGREEMENT TERM (“Term”). 36-Months commencing on the Effective Date.

3.

PURCHASE COMMITMENTS. In exchange for Quidel’s agreement to provide Customer with Equipment Use at no charge during the Term of this Agreement as indicated on Exhibit A attached hereto, Customer shall purchase the following Consumables in the following amounts and prices, and shall satisfy its total requirements (the “Annual Purchase Obligation”) for Consumables in each point of care immunoassay test category (e.g., natriuretic peptide) for the duration of the Term of the Agreement from Quidel. Catalog Number

Product Triage BNP Panel 25T

98000XR

Triage BNP Controls Level 1 - 5T

The customer agrees to purchase a minimum of 60 boxes of the selected Product(s) listed below within 12 months from the date set forth on this agreement.

Triage BNP Controls Level 2 - 5T

Customer Price Per Kit $

98013XR

$

98014XR

$

Annual Purchase Obligation Tests $ (Dollar Amount) $ $ $

Triage BNP Calibration Verification Set – 2 Sets/5T each

98015XR

$

Triage Cardiac Panel 25T Triage Cardiac Panel/BNP Combo 50T/2kts - one of BNP and Cardiac Triage Cardiac Panel/BNP, D DIMER Combo 75T/3kts one of BNP, D DIMER and Cardiac Triage Cardiac Panel TNI 25T Triage TNI+BNP+D DIMER Combo 75T/3kts - one of BNP, D DIMER and TNI Triage Cardiac Panel TNI/CK-MB 25T Triage TNI/CK-MB with BNP 50T/2kts – one of BNP and TNI/CK-MB Triage TNI/CK-MB with BNP+ D DIMER 75T/3kts – one of BNP, D DIMER and TNI/CK-MB

97000HS

$

$

97000B

$

$

97000BD

$

$

97021HS

$

$

97021BD

$

$

Triage D-Dimer Panel 25T TRIAGE KIT, CONTROL Level 1, TC5 - includes BNP, D DIMER, CK-MB, MYO, TNI - 5 Vials per box TRIAGE KIT, CONTROL Level2, TC5 includes BNP, D DIMER, CKMB, MYO, TNI - 5 Vials per box Triage Total Calibration Verification 2 Sets/5T each – total 10T Triage Census ATM Software

Chemistry

“Ship To” (If different than Sold To):

2.

Q: Who may consider this program? A: This program is available only to specific customer clinic locations that have not previously purchased a LeadCare® II Analyzer. The program is suitable for customers who prescribe a minimum of seven lead tests per week.

“Sold To” (Notice Address):

1.

Frequently Asked Questions

Medline agrees to sell and the Customer agrees to purchase monthly the minimum quantities of products and at the prices indicated below, during a period of twenty-four (24) months from the Agreement date above. Medline may choose to ship product on a standing order basis.

The 3 Box agreement and 5 Box agreements are for new customers only. These promos include the meter and either 3 or 5 boxes of test strips. There are 50 tests per box for a total of 150 or 250 tests. The 3 Box Promo is only available within certain promotional periods.

Customer Information Facility Name Address City, ST, ZIP Primary Contact Phone E-Mail Fax Quidel Customer #

Free use of a LeadCare II Analyzer to new customers who:

This AGREEMENT ("Agreement") is made and entered into this __ day of __, 20__ between Medline. and ______________________________ ("Customer").

Coag-Sense PT/INR Monitoring System Supply Agreement

TRIAGE PLACEMENT AGREEMENT This Triage Placement Agreement (the “Agreement”) is entered into by and between Quidel Corporation, a Delaware corporation (“Quidel”), having a place of business at 12544 High Bluff Drive, San Diego, CA 92130 (“Quidel Notice Address”), and the customer set forth below (“Customer”).

®

Hematology

97022HS

$

$

97022B

$

$

97022BD

$

$

98100

$

$

88753

$

$

88754

$

$

88755

$

$

55069

$

$

Aggregate Annual Consumable Purchase Obligation:

Immunoassay

$

$

If Quidel determines that Customer has not met the Annual Purchase Obligation at the end of any contract year, then Customer shall have 30 days from the end of the applicable annual period to meet the purchase commitments. If Customer fails to cure the Annual Purchase Obligation, then Quidel may, in its discretion, either: (i) raise pricing for the remaining Term of the Agreement based on volumes actually purchased or (ii) terminate the Agreement and cause Customer to (and Customer agrees that it shall) return all Equipment at Customer’s expense and pay to Quidel an amount equivalent to the depreciated value of the Equipment at the termination date using straight line depreciation and list price for the Equipment on the Effective Date. The

Specialty

Triage Placement Agreement - 01.08.18 1/8/2018

1

ESR DCA Vantage Starter Kit Agreement

DCA Vantage Program Agreement

Blood Gas 2018 DCA Vantage® Analyzer Placement Program Agreement Promotion Codes: PLACEDCA/PLACEDCA5 (Jan. 1, 2018 to Dec. 31, 2018)

2018 DCA Vantage® Analyzer Starter Kit Program Agreement Promotion Codes: STARTA1C/STARTA1C5 (Jan. 1, 2018 to Dec. 31, 2018)

Complete this form and fax to Siemens Commercial Services (888) 242-9448 OR Email to: customerservicedistributors.healthcare@siemens.com

Complete this form and fax to Siemens Commercial Services (888) 242-9448 OR Email to: customerservicedistributors.healthcare@siemens.com Ship to Entity (“Customer”)

Legal Name Address (City, State, Zip) Contact Name and Title Email and Phone No. Date Siemens Sales Rep Name

Ship to Entity (“Customer”)

Legal Name Address (City, State, Zip) Contact Name and Title Email and Phone No. Date Siemens Sales Rep.

Distributor Information

Distributor Name Distributor Rep Name Email and Phone No. Distributor PO # Distributor Customer Acct #

Tier 1 Tier 2

1.

Siemens Healthcare Diagnostics Inc. (“Siemens”) agrees to sell to the Distributor for a price of $2,000.00 and to ship to the Customer indicated above, a DCA Vantage® Analyzer (Siemens Item No. 5075US) valued at $2995.00 (the "Instrument”) in accordance with the applicable provisions of that certain distribution agreement (“Distribution Agreement”) between Distributor and Siemens and the terms herein (“Purchase Agreement”). In case of a conflict between the terms of the respective Agreements, the terms of the Distribution Agreement shall control.

2.

Provided herein at no additional charge are 1 DCA HbA1c Reagent Kit (Siemens item No. 5035C) valued at $84.50 and 1 DCA HbA1c Control Kit (Siemens item No. 5068A) valued at $90.58. Distributor agrees to purchase directly from Siemens, for use by Customer, DCA HbA1c Reagent Kit products at the net rebated contract cost of $50.00 for the Term of this Purchase Agreement. The contract cost herein is not transferable to any other distributor for this Customer. Customer’s name and address must match for proper processing of charge back claims. The term of this Purchase Agreement is thirty-six (36) months (“Term”) and shall commence thirty (30) days after shipment of the Instrument to the Customer. Distributor shall submit sales tracing to Siemens sufficient for Siemens to verify rebates/chargebacks.

3.

Distributor Information

Distributor Name Distributor Rep Name Email and Phone No. Distributor PO # Distributor Customer Acct. #

Check One Tier

Check the desired warranty

36 months of analyzer warranty at no charge (PROMO CODE: STARTA1C) 60 months of analyzer warranty at a promotional price of $250 will be added to the analyzer price of $2000 (PROMO CODE: STARTA1C5)

4.

Subject to the provisions of Paragraph 2, Siemens will provide full service on the Instrument, valued at $979.00 annually, as per the warranty coverage selected above in accordance with Siemens’ standard service policy.

5.

This Purchase Agreement is subject to acceptance by Siemens.

6.

Distributor agrees (i) not to seek reimbursement from any private or public (e.g., Medicare or Medicaid) insurance for any Reagent Kit or service at no additional charge or at reduced charge by Siemens; or, in the alternative, (ii) to properly disclose and appropriately reflect discounts or price reductions, including items provided at no additional charge or at reduced charge by Siemens, in such costs claimed or charges made for reimbursement, or in response to requests by government agencies for such price reduction and disclosure.

Tier 3 Tier 4

Minimum of 4 per month of DCA HbA1c #5035C priced at $65.00 per box and / or Microalbumin/ Creatinine Reagent Kits #6011A priced at $65.00 per box (in any combination)

Coagulation

Minimum of 8 per month of DCA HbA1c #5035C priced at $63.86 per box and / or Microalbumin/ Creatinine Reagent Kits #6011A priced at $62.00 per box (in any combination) Minimum of 12 per month of DCA HbA1c #5035C priced at $57.75 per box and / or Microalbumin/ Creatinine Reagent Kits #6011A priced at $62.00 per box (in any combination) Minimum of 20 per month of DCA HbA1c #5035C priced at $54.00 per box and / or Microalbumin/ Creatinine Reagent Kits #6011A priced at $62.00 per box (in any combination)

Check the desired warranty

36 months of analyzer warranty at no charge (PROMO CODE: PLACEDCA) 60 months of analyzer warranty at a promotional price of $250.00 (PROMO CODE: PLACEDCA5)

1.

Siemens Healthcare Diagnostics Inc. (“Siemens”) agrees to place the DCA Vantage Analyzer ("Instrument”) valued at $2,995.00 per system at the Customer location indicated above in accordance with the applicable provisions of that certain distribution agreement (“Distribution Agreement”) between Distributor and Siemens and the terms herein (“Placement Agreement”). In case of a conflict between the terms of the respective Agreements, the terms of the Distribution Agreement shall control.

2.

Distributor agrees to purchase the minimum quantity of Reagent Kits designated above from Siemens during the Agreement Term (“Commitment Amount”) for shipment each month from its inventory to the Customer identified above. The contract cost as stated above is not transferable to any other distributor for this Customer.

3.

The initial term of this Placement Agreement is thirty six (36) months (“Initial Term”) and shall commence thirty (30) days after shipment of the Instrument to the Customer. Upon completion of the Initial Term and subject to the provisions of paragraph 2, Siemens shall pass title of the Instrument to Distributor. Further, this Placement Agreement shall automatically renew on a yearly basis (each, a “Renewal Term”) until terminated by either party as provided for herein. The total term of this Placement Agreement shall be the Initial Term plus any Renewal Terms (“Term”).

4.

On January 1 of any calendar year during the Term, Siemens may increase the prices for Reagent Kits specified herein, up to five (5) percent. Siemens will notify Distributor in writing at least 30 days before the effective date of any such price increase.

5.

Either party may terminate this Placement Agreement for its convenience at any time during the Term by giving the other at least thirty (30) days prior written notice of its intent to do so. The effective date of termination of this Placement Agreement shall be on the last calendar day of the month in which notice of termination is given to the other party. In the event of termination during the Initial Term at either the request of the Distributor or by Siemens, Distributor shall have the responsibility to retrieve the Instrument from Customer and return the Instrument to Siemens within forty five (45) days of the effective date of such termination. Distributor must obtain authorization from Siemens to return such Instruments by calling 1-877-885-4873. A return authorization number must accompany each returned Instrument. Distributor will be responsible for the costs of the proper packing, the proper storage (if applicable), and the freight charges associated with returning the Instrument to Siemens.

Chargebacks must be submitted using the customer’s name and address as indicated above. 6.

Distributor shall provide Siemens with sales tracing sufficient for Siemens to determine whether volume commitments are being met by customer. If during the Term, it is determined by Siemens that actual average monthly Reagent Kits is less than the Commitment Amount, then Siemens shall change the prices for Reagent Kits herein to the price that corresponds to the Tier pricing for the actual volume of Reagent Kits purchased. If the actual average monthly Reagent Kits purchased is less than the volume in Tier 1, then; •

During the Initial Term - Siemens may terminate this Placement Agreement, effective on the thirtieth day after notification. Distributor shall either return the Instrument to Siemens pursuant to paragraph 5 above or purchase the analyzer at its fair market value.

During the Renewal Term - This Placement Agreement shall expire at the end of the then-current contract year and shall not automatically renew. Distributor is not required to return the Instrument to Siemens.

7.

The Instrument involved in this Placement Agreement shall remain the property of Siemens for the Initial Term of this Agreement. The Distributor shall be responsible for risk of loss and damage to the Instrument during the Initial Term. Siemens shall have no obligation with respect to operation or use of Instrument other than that specified in the operation manual which accompanies the Instrument.

8.

Subject to the provisions of Paragraph 2, Siemens will provide full service on the Instrument, valued at $979.00 annually as per the warranty coverage selected above in accordance with Siemens’ standard service policy.

9.

This agreement is subject to acceptance by Siemens.

10.

Distributor agrees (i) not to seek reimbursement from any private or public (e.g., Medicare or Medicaid) insurance for any Reagent Kit or service provided at no additional charge or at reduced charge by Siemens; or, in the alternative, (ii) to properly disclose and appropriately reflect discounts or price reductions, including items provided at no additional charge or at reduced charge by Siemens, in such costs claimed or charges made for reimbursement, or in response to requests by government agencies for such price reduction and disclosure.

Cardiac

Chargebacks must be submitted using the customer’s name and address as indicated above.

2018 DCA Vantage Starter Kit Program Agreement_BLANK[3].doc

Page 1 of 1 2018 DCA Vantage Placement Program Agreement_BLANK[5].doc

Page 1 of 1

LIS/Resources Forms


Lab Portfolio Lab Lead Form

Medline Lab Information Form

Medline Lab Information Form

HbA1c and Glucose

Lipid Profile

Medline POC Date: ____________________________________________ Facility’s current CLIA complexity level (choose one):

Highly Moderate Waived None

Account Name: ___________________________________________________________________________________________  Account Number: _____________________________

Influenza A & B / RSV

Address: ____________________________________________________________________ City, State, ZIP: ______________________________________________________________ Financial Buyer Name: ____________________________________________________ Email: _________________________________________________________________________

Strep

Technical Buyer Name: ____________________________________________________ Email: _________________________________________________________________________ Phone #: ________________________________________ Type of Practice: _________________________________________________________________________________________

Additional POC

IDN: __________________________________ GPO: __________________________________ LIS: __________________________________ EMR: __________________________________

Purchase Preference (choose one): Purchase Timeframe (choose one):

Urinalysis Rent Own Lease 3 months 6Immediate 12 months

Hematology

Please check the discipline where there is an opportunity: Hematology:      Chemistry:      Immunoassay:      Other:   Please check the time range for volumes:

Chemistry

Yearly:     Monthly:     Weekly:     Daily: Please list test volumes: CMP: __________________  BMP: __________________ Lipids: __________________ Hepatic: __________________ Renal: __________________ DOA: __________________

Immunoassay

CBC: ___________________ TSH: ___________________ PSA: ___________________ VIT D: ___________________ B12: ___________________ FOLATE: ___________________ Ferritin: _________________ Testo: _________________ T3: _________________ T4: _________________ Prolactin: _________________ Progesterone: _________________

Specialty

Others: _______________________________________________________________________________________________________________________________________________________ ACCOUNT PAYER MIX

ESR

Private Pay: _______________  Medicare: _______________ Insurance: _______________ HMO: _______________ Medicaid: _______________ Other: _______________ Fill in above with % of patients covered—the total should be 100%

Blood Gas

Current Systems: __________________________________________________________ Current Ref Lab: _____________________________________________________________ Notes/Comments: __________________________________________________________________________________________________________________________________________

Coagulation

________________________________________________________________________________________________________________________________________________________________ Rep Name: _________________________________________________________________ Rep Number: _________________________________________________________________

Cardiac

Division Manager: __________________________________________________________ Lab Capital Specialist: _______________________________________________________ © 2020 Medline Industries, Inc. All rights reserved. Medline is a registered trademark of Medline Industries, Inc. 19W694762 / e20056 / 19

LIS/Resources Forms


Lab Portfolio Lab Lead Form

CPT Code Sheet

HbA1c and Glucose

Rep Name - Title (555) 555-1234 Lab Products –National Reimbursement & Coding for 2020 For your convenience, here is a summary of commonly performed CLIA-WAIVED lab tests. Please see your Medline representative for pricing and for information on products not seen here.

Procedure:

CPT Code:

Medicare Reimbursement:

HbA1C

83036QW

$9.71

Glucose - Hemocue

82947QW

$3.93

Glucose

82962

$3.28

Lipid Profile

80061QW

$13.39

Pregnancy

81025QW

$8.61

Fecal Occult Immunoassay (iFOBT)

82274QW or G0328QW

$15.92

Fecal Occult Guiaic

82270

$4.38

Mono

86308QW

$5.18

Strep A Rapid

87880QW

$16.53

Strep A Molecular

87651QW

$35.09

Influenza A/B

87804QW x 2

$33.10

Influenza A + B Molecular

87502QW

$95.80

RSV

87807QW

$13.10

Influenza A + B/RSV Molecular

87631QW

$142.63

H. Pylori

86318QW

$18.09

HIV

86703

$13.71

TSH

84443QW

$16.80

Bacterial Vaginosis

87905QW

$12.22

Syphilis (Treponema Pallidum)

86780QW

$13.24

Trichomonas

87808QW

$15.29

DOA

80305

$12.60

Hemoglobin

85018QW

$2.37

PT/INR

85610QW

$4.29

81003QW

$2.25

81002

$3.48

81003QW & 82570QW

$7.43

Microalbumin w/ Creatinine

82044QW & 82570QW

$11.41

Lead

83655QW

$12.11

BNP

83880QW

$39.26

CMP (waived)

80053QW

$10.56

Lyme

86618QW & 86618QW-59

$34.06

Urinanalysis, automated, without microscopy Urinalysis non-automated, without microscopy Multistix PRO Albumin w/ Creatinine

All information provided here is most recent as of January 2020 obtained from: https://www.cms.gov/apps/ama/license.asp?file=/Medicare/Medicare-Fee-for-ServicePayment/ClinicalLabFeeSched/Downloads/20CLABQ1.zip It is always the provider's responsibility to determine appropriate coding, claims, and charges for a procedure

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Lab Lead Form

CPT Code Sheet

HbA1c and Glucose

Lipid Profile

Rep Name - Title (555) 555-1234 Lab Products – National Reimbursement & Coding for 2020 For your convenience, here is a summary of commonly performed MODERATELY COMPLEX lab tests.

Medline POC

Please see your Medline representative for pricing and for information on products not seen here.

Procedure: CMP HbA1c Hepatic Iron Liver BMP Glucose Creatinine Vitamin B12 Folate Ferritin Total PSA free PSA Total BhCG LH FSH Prolactin Estradiol Progesterone Testosterone TSH Free T4 Free T3 Vitamin D CBC-3 part diff CT/NG HSV1+2/VZV Strep Complete (Group A,C,G) Group B Strep Trichomoniasis IEg (Allergy)

CPT Code: Chemistry 80053 83036 80076 83540 80061 80048 82947 82565 Immunoassay 82607 82746 82728 84153 84154 84703 83002 83001 84146 82670 84234 84403 84443 84439 84481 82306 Hematology 85025 Specialty/Other 87491 & 87591 87529 ,87529-59 & 87798 87651 & 87798 87150 87661 86003 x # of Allergens

Medicare Reimbursement: $ 10.56 $ 9.71 $ 8.17 $ 6.47 $ 13.39 $ 8.46 $ 3.93 $ 5.12 $15.08 $14.70 $13.63 $18.39 $18.39 $7.52 $18.52 $18.58 $19.38 $27.94 $64.88 $25.81 $16.80 $9.02 $16.94 $29.60

Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR

$7.77 $35.09 x 2= $70.18 $35.09 x 3= $105.27 $35.09 x 2= $70.18 $35.09 $35.09 $5.22 x # of Allergens

All information provided here is most recent as of January 2020 obtained from: https://www.cms.gov/apps/ama/license.asp?file=/Medicare/Medicare-Fee-for-ServicePayment/ClinicalLabFeeSched/Downloads/20CLABQ1.zip It is always the provider's responsibility to determine appropriate coding, claims, and charges for a procedure

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Placement Agreement

PO Lab Ordering Checklist By Specialty

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline POC

Lab Products for Physician’s Office Specialty Cardiology

Point-of-Care

___ BNP (Triage) Tests ___ Cholesterol (Lipids) Tests ___ PT/INR Tests

Chemistry ___ CMP ___ BNP

Immunoassay ___ Vitamin D ___ TSH ___ FT3 ___ F4

Community Health Centers Point-of-Care

Sexual Health

___ Bacterial Vaginosis Tests ___ Chlamydia Tests ___ Gonorrhea Tests ___ Herpes Tests ___ HIV Tests ___ Trichomonas Tests

Endocrinology Point-of-Care

___ Blood Glucose Tests ___ Hemoglobin A1c Tests ___ Urinalysis Tests ___ Microalbumin Tests

Hematology

___ CBC-3 part diff

___ Allergy Tests ___ Blood Glucose Tests ___ BNP (Triage) Tests ___ C-Diff Tests ___ Cholesterol (Lipids) Tests ___ Drugs of Abuse Tests ___ Fecal Occult Blood Tests (iFOBT) ___ Fecal Occult Blood Tests (Guaiac) ___ Hemoglobin Tests ___ Hemoglobin A1c Tests ___ H. pylori Tests ___ Influenza A&B Tests ___ Lead Tests ___ Microalbumin Tests ___ Mono Tests ___ Pregnancy Tests ___ PT/INR Tests ___ RSV Tests ___ Strep A Tests ___ Thyroid (TSH) Tests ___ Urinalysis Tests

Chemistry

Hematology

___ FSH ___ LH ___ Prolactin ___ Progesterone ___ Estradiol ___ TSH ___ BhCG ___ DHEA ___ AMH

___ CBC-3 part diff

Chemistry ___ CMP ___ BMP

___ CMP ___ Hemoglobin A1c Tests

Immunoassay

___ TSH ___ FT3 ___ FT4 ___ Vitamin D ___ Testosterone ___ Thyroglobulin ___ Thyroglobulin Antibody ___ Prolactin ___ Estradiol ___ FSH ___ LH ___ Folate ___ Cortisol ___ SHBG

Fertility

Immunoassay

Imaging

Point-of-Care

Influenza A & B / RSV

___ Pregnancy

Chemistry

___ Creatinine

Internal Med/Family Practice Point-of-Care

___ Allergy Tests ___ Blood Glucose Tests ___ BNP (Triage) Tests ___ C-Diff Tests ___ Cholesterol (Lipids) Tests ___ Drugs of Abuse Tests ___ Fecal Occult Blood Tests (iFOBT) ___ Fecal Occult Blood Tests (Guaiac) ___ Hemoglobin Tests ___ Hemoglobin A1c Tests ___ H. pylori Tests ___ Influenza A&B Tests ___ Lead Tests ___ Microalbumin Tests ___ Mono Tests ___ Pregnancy Tests ___ PT/INR Tests ___ RSV Tests ___ Strep A Tests ___ Thyroid (TSH) Tests ___ Urinalysis Tests

Hematology

___ CBC-3 part diff

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR

Chemistry ___ CMP ___ BMP

Blood Gas

Immunoassay ___ Vitamin D ___ TSH ___ FT3 ___ FT4 ___ PSA

Sexual Health

___ Bacterial Vaginosis Tests ___ Chlamydia Tests ___ Gonorrhea Tests ___ Herpes Tests ___ HIV Tests ___ Trichomonas Tests

Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Placement Agreement

PO Lab Ordering Checklist By Specialty

Lab Lead Form HbA1c and Glucose

Nephrology

Point-of-Care

___ Blood Glucose Tests ___ Cholesterol (Lipids) Tests ___ Hemoglobin A1c Tests ___ Urinalysis ___ Microalbumin

Hematology

___ CBC-3 part diff

Chemistry

___ CMP ___ Creatinine ___ Renal Panel

Immunoassay ___ TSH ___ FT3 ___ FT4 ___ Ferritin ___ B12

OB/GYN

Point-of-Care

___ Blood Glucose Tests ___ C-Diff Tests ___ Cholesterol (Lipids) Tests ___ Fecal Occult Blood Tests (iFOBT) ___ Fecal Occult Blood Tests (Guaiac) ___ Hemoglobin Tests ___ Hemoglobin A1c Tests ___ Influenza A&B Tests ___ Mono Tests ___ Pregnancy Tests ___ Strep A Tests ___ Thyroid (TSH) Tests ___ Urinalysis Tests

Immunoassay

___ FSH ___ LH ___ Prolactin ___ Progesterone ___ Testosterone ___ Estradiol ___ TSH ___ FT3 ___ FT4 ___ Thyroglobulin Antibody ___ BhCG ___ Folate ___ Ferritin ___ CA 19-9 ___ CA 15-3 ___ CEA ___ CA 125 ___ AFP ___ DHEA

Hematology

___ CBC-3 part diff

Chemistry ___ CMP ___ Iron

Sexual Health

___ Bacterial Vaginosis Tests ___ Chlamydia Tests ___ Gonorrhea Tests ___ Herpes Tests ___ HIV Tests ___ Trichomonas Tests

Oncology/Hematology Point-of-Care

___ PT/INR Tests

Hematology

___ CBC-5 or 3 part diff

Chemistry ___ CMP

Immunoassay ___ B12 ___ Vitamin D ___ CEA ___ CA-125 ___ CA 15-3 ___ CA 19-9 ___ AFP

Pain Management Point-of-Care

___ Drugs of Abuse Tests

Chemistry

___ Drugs of Abuse (DOA)

Pediatrics

Point-of-Care

___ Allergy Tests ___ Blood Glucose Tests ___ Cholesterol (Lipids) Tests ___ Drugs of Abuse Tests ___ Hemoglobin Tests ___ Influenza A&B Tests ___ Lead Tests ___ Mono Tests ___ Pregnancy Tests ___ RSV Tests ___ Strep A Tests ___ Thyroid (TSH) Tests ___ Urinalysis Tests

Hematology

___ CBC-3 part diff

Chemistry

___ Bilirubin

Pulmonologist Point-of-Care

___ Allergy Tests

Hematology

Lipid Profile

___ CBC-3 part diff

Chemistry

___ CMP ___ Blood gases ___ Electrolytes

Rheumatology

Medline POC Influenza A & B / RSV

Hematology

___ CBC-3 part diff

Chemistry

Strep

___ CRP ___ CMP

Urgent Care

Additional POC

Point-of-Care

___ Allergy Tests ___ Blood Glucose Tests ___ BNP (Triage) Tests ___ Drugs of Abuse Tests ___ Influenza A&B Tests ___ Mono Tests ___ Pregnancy Tests ___ PT/INR Tests ___ RSV Tests ___ Strep A Tests ___ Urinalysis Tests

Urinalysis Hematology

Chemistry

Hematology

___ CBC-3 part diff

Immunoassay

Chemistry

___ CMP ___ BMP ___ Troponin ___ CK-MB

Sexual Health

___ Bacterial Vaginosis Tests ___ Chlamydia Tests ___ Gonorrhea Tests ___ Herpes Tests ___ HIV Tests ___ Trichomonas Tests

Urology

Point-of-Care

Specialty

ESR Blood Gas Coagulation

___ Urinalysis Tests

Hematology

___ CBC-3 part diff

Cardiac

Immunoassay

___ PSA ___ FPSA ___ p2PSA*new ___ Testosterone

LIS/Resources Forms

Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this sheet. © 2018 Medline Industries, Inc. Medline is a registered trademark of Medline Industries, Inc. MKT1899923 / 460R / 2.5M / DP / 15


Lab Portfolio Placement Agreement

EVENCARE Meter Agreement

Lab Lead Form HbA1c and Glucose

Lipid Profile

Medline Account Number: Date:

Medline POC

EVENCARE Meter Agreement

Influenza A & B / RSV

Customer has agreed to purchase glucose test strips from Medline. Medline and Customer acknowledge the EVENCARE test strips cannot be read without the respective EVENCARE glucose meter. Medline agrees to supply the EVENCARE meters in the quantities indicated for Customer’s own use at no additional cost to Customer. This agreement is valid for five years from the date of execution.

By completing and signing below, Customer acknowledges and agrees that any meter provided by Medline hereunder shall not be claimed as a reimbursable expense or reflected as a reimbursable expense on any cost report under any federal or state health program.

Strep

Additional POC

Urinalysis Item

MPH1540 MPH3540

Description

Estimated Annual Quantity Needed

Hematology

EVENCARE G2 Glucose Meter

(Approved for Single Patient Use and Multi-Patient Use)

Chemistry

EVENCARE G3 Glucose Meter

(Approved for Multi-Patient Use Only)

MPH4540

EVENCARE ProView Glucose Meter

MPH5540

EVENCARE Mini Glucose Meter

MPH6540

EVENCARE Harmony Glucose Meter

(Approved for Multi-Patient Use Only)

(Approved for Single Patient Use Only)

(Approved for Multi-Patient Use Only)

Immunoassay

Specialty

ESR Blood Gas Coagulation

Authorized Signature: Print Name/Title:

Please fax this agreement to 847-643-3455 before ordering meters and test strips.

Cardiac LIS/Resources Forms


Lab Portfolio Coag-Sense PT/INR Monitoring System Agreement

Placement Agreement

Lab Lead Form HbA1c and Glucose

Medline Account Number:___________________________ Date:___________________________

Lipid Profile

Medline POC

Coag-Sense PT/INR Monitoring System Supply Agreement

Influenza A & B / RSV

Customer has agreed to purchase the Coag-Sense PT/INR system from Medline. Medline and Customer acknowledge the Coag-Sense test strips cannot be read without the respective Coag-Sense meter. Medline agrees to supply the Coag-Sense meter at a discounted rate in the associated packages.

Strep

Additional POC

3 Box Promo and 5 Box Promo

The 3 Box agreement and 5 Box agreements are for new customers only. These promos include the meter and either 3 or 5 boxes of test strips. There are 50 tests per box for a total of 150 or 250 tests. The 3 Box Promo is only available within certain promotional periods.

Item

ABO06F2303 ABO06F2364

Description

Promo Price

Urinalysis Hematology

Coag-Sense 3 Box Promo

(Contains 50 test strips, 4 control strips and 54 transfer tubes per box, and meter)

Coag-Sense 5 Box Promo

Chemistry

(Contains 50 test strips, 4 control strips and 54 transfer tubes per box, and meter)

Immunoassay

Specialty By completing and signing below, Customer acknowledges and agrees that any meter provided by Medline hereunder shall not be claimed as a reimbursable expense or reflected as a reimbursable expense on any cost report under any federal or state health program.

ESR

Authorized Signature: ______________________________________________________________ Print Name/Title: __________________________________________________________________ Please fax this agreement to 847-643-3455 before ordering meters and test strips.

Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Alere Cholestech LDX System Placement Agreement

Placement Agreement

Lab Lead Form HbA1c and Glucose

Medline Account Number: ________________ Medline Sales Rep: ______________________ #: ________

Lipid Profile

Begin Date: _____ / _____ / _________

Medline POC

Alere Cholestech LDX® System Placement Agreement

FAX COMPLETED FORM IMMEDIATELY TO MEDLINE DIAGNOSTICS AT 1-847-643-3338

Influenza A & B / RSV

This AGREEMENT ("Agreement") is made and entered into this __ day of __, 20__ between Medline. and ______________________________ ("Customer"). Any reference to “Placement” or “Agreement” shall mean this document and any and all schedules or addenda attached at any time hereto.

Strep

This Agreement enables the Customer to purchase the Products identified below in the indicated quantities and at the indicated prices, and qualify for the use, service and upgrades of the Alere Cholestech LDX System (“Equipment”) indicated in the first point of this Agreement at no charge.

Additional POC

Medline agrees to sell and the Customer agrees to purchase monthly the minimum quantities of products and at the prices indicated below, during a period of twenty-four (24) months from the Agreement date above. Medline may choose to ship product on a standing order basis.

Urinalysis

1. Minimum Commitment

Hematology

Medline will supply one Alere Cholestech LDX System (“Equipment”) at no additional cost to Customer for a commitment to purchase a total of 120 boxes of the selected Product(s) listed below over the next 24 calendar months upon receipt of the Equipment.

Chemistry

The customer agrees to purchase a minimum of 60 boxes of the selected Product(s) listed below within 12 months from the date set forth on this agreement. Medline agrees to reconcile the test kit purchases with Customer once a year. Based on this reconciliation, Medline will confirm the number of boxes of strips purchased by Customer and will provide Customer with a purchase summary.

Immunoassay

Specialty

Alere Cholestech LDX® Meter Placement Agreement (MPA) Customer Commitments: Product Commitment – Check One: Lipid-Glucose (Alere #10-991)

_______

Medline # CHLS10991

Price $ ____________

Lipid

_______

Medline # CHLS10989

Price $ ____________

TC/HDL/GLU (Alere #10-990) _______

Medline # CHLS10990

Price $ ____________

TC/HDL

Medline # CHLS10987

Price $ ____________

(Alere #10-989)

(Alere #10-987) _______

ESR

Implementation Pack – (One-time Purchase Commitment) – Check One: Alere Cholestech LDX® System must ship with one of the following Implementation Packs, please select one: Lipid-Glucose (Alere #14-205) _______

Medline # CHLS14205

Price $ 401.00

Lipid

(Alere #14-206) _______

Medline # CHLS14206

Price $ 365.00

TC/HDL/GLU (Alere #14-207) _______

Medline # CHLS14207

Price $ 320.00

TC/HDL

Medline # CHLS14208

Price $ 290.00

(Alere #14-208) _______

Blood Gas Coagulation

The above “Implementation Packs” include the Alere Cholestech LDX® System, Printer, One (1) Box of Controls, “starter” supply pack and Three (3) Boxes of selected “Test”.

Cardiac LIS/Resources 1

Forms


Lab Portfolio Alere Cholestech LDX System Placement Agreement

Placement Agreement

Lab Lead Form HbA1c and Glucose

ACKNOWLEDGMENT: By completing and signing below, Customer and/or its facilities will report any discounts or rebates earned and paid under this Agreement on its/their institutional cost report(s), or otherwise disclose the amount of the discount or rebate to the appropriate federally funded program, in compliance with the discount safe harbor provisions of the Anti-Kickback Statute and its implementing regulations. 42 CFR § 1001.952(h). All discounts and rebates will be provided based on purchases of products within a single fiscal year of Customer, and the terms of the discounts and rebates are fixed as set forth in this Agreement.

Lipid Profile

Medline POC

2. Terms and Conditions Medline works directly with the manufacturer, Alere, for warranty and repair of all Alere Cholestech LDX products. Alere shall repair or replace Equipment that is defective in materials or workmanship. Except for routine preventive maintenance performed by the Customer, all warranties are immediately void if, at any time, repair is made or attempted by anyone other than Alere or an authorized service person. Alere will not be responsible at any time for the cost of repairs or replacement of any part of the Equipment resulting from negligent or intentional acts of, or misuse by the Customer or failure to perform preventive maintenance as indicated in the operating manual of the Equipment. Alere agrees to provide ongoing technical service and support for the Equipment in a manner consistent with Alere standards and emergency policies and procedures in effect at the time of required service and at no additional cost to Customer. Alere shall provide necessary information about the service and repair time when repairs are needed. This transaction is a no-charge placement and not a sale. The Equipment supplied to the Customer is the sole property of Medline. The Customer agrees to the filing of forms UCC-1 or other forms for the purpose of providing notice to the Customer's creditors of Alere prior right to interest in and claims upon the Equipment. The Customer hereby authorizes Medline to file a financing statement with respect to the Equipment, signed only by Medline, or its agent where permitted by the Uniform Commercial Code or any other regulation adopted by any jurisdiction where the Equipment is located. In the event any jurisdiction requires the Customer to execute a financial statement, the Customer hereby appoints Medline or its agent as the Customer's attorney. The Customer agrees to reimburse Medline for the expenses incurred in preparing such financial statements.

Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

The Equipment shall be kept at the location specified for delivery. Only Medline or its agents are allowed to remove or relocate the Equipment. The Customer certifies and warrants that the Equipment is for its own use and will not be sold or otherwise transferred without the written consent of Medline.

Chemistry

The Customer agrees to notify in writing to the Accounting Department of Medline of any changes in Customer's legal name, address, and location of the Equipment. The Customer shall bear the entire risk of loss, theft, destruction or damage of or to the Equipment from any cause whatsoever. The Customer shall make no alteration and/or attachment to the Equipment without the express written consent of Medline. In addition, the Customer shall not remove, alter or cover any label, signs, symbols or serial number that may be attached to the Equipment

Immunoassay

If Customer fails to purchase the minimum amount of products indicated above, Medline shall have the right to ship and bill the Customer the amount of product necessary to meet the minimum amount of products, or remove the Equipment and charge $300.00 return fee for Equipment.

Specialty

ESR

This Agreement is construed and governed by the laws of the State of Illinois.

Blood Gas

Medline shall have the right to increase the prices of the product each year in a percentage that will not exceed the US Consumer Price Index.

Coagulation

The Customer may not assign this Agreement at any time without the express and written consent of Medline. The Customer shall not: (1) assign, transfer pledge, hypothecate, grant any security interest in or otherwise dispose of the Equipment or any interest therein (2) sublet or lend the Equipment or permit it to be used by anyone other than Medline, Medline employees or agents without Medline prior written consent. Any amendment to this Agreement shall be valid only if made in writing.

Cardiac

Any notice or other communications required or which may be given hereunder shall be in writing.

LIS/Resources 2

Forms


Lab Portfolio Placement Agreement

Alere Cholestech LDX System Placement Agreement

Lab Lead Form HbA1c and Glucose

BY WITNESS WHEREOFF, Medline and Customers have accepted this Alere Cholestech LDX System Program Agreement as of the date first above written. This Agreement does not become effective unless and until it is executed by an officer of Medline and an authorized representative of the Customer.

CUSTOMER

Medline Industries, Inc.

Signed: ____________________________

Signed:

Name/Title: _________________________

Name/Title:

Date: ______________________________

Date:

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources 3

Forms


Lab Portfolio Magellan LeadCare II Placement Program

Placement Agreement

Lab Lead Form HbA1c and Glucose

Valid: 01/1/20 – 12/31/20 Lipid Profile

Placement Program Free use of a LeadCare® II Analyzer to new customers who: Purchase four (4) LeadCare® II Test Kits, and Commit to purchase eight (8) test kits annually (384 tests). (The initial four-kit purchase counts toward the first year’s eight-kit commitment.)

Frequently Asked Questions Q: Who may consider this program? A: This program is available only to specific customer clinic locations that have not previously purchased a LeadCare® II Analyzer. The program is suitable for customers who prescribe a minimum of seven lead tests per week.

Q: Is this a “rent-to-own” program?

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

A: No. Meridian Bioscience will own the analyzer for as long as the agreement is in effect. The analyzer will be covered under warranty as long as the agreement is in effect.

Q: What happens if we have more than one location? A: Great! Meridian Bioscience is interested in supporting testing at all customer locations. Contact us for more information about using LeadCare® II at multiple sites.

Q: What happens if the purchase commitment is not met? A: If the customer stops testing, or does not meet the purchase commitment, Meridian Bioscience will contact the customer for the return of the analyzer from the customer’s facility.

Q: What do I do next? A: Customer and sales representative sign the Placement Program Agreement, certifying that each understands the commitment, and that the customer has sufficient volume to use at least the minimum required number of kits (8/year). Deliver the signed agreement and a purchase order for the promotion code to your sales representative for processing. The analyzer and four test kits will be drop shipped from Meridian Bioscience directly to the customer. Contact: LeadCare Sales 1-800-305-0197 LeadCareSales@meridianbioscience.com www.meridianbioscience.com © 2020 All rights reserved. LeadCare is a registered trademark of Meridian Bioscience. All other trademarks belong to their respective owners. MBI_LC_II_Placement_Contract_Medline_2019-12

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Placement Agreement

Magellan LeadCare II Placement Program

Lab Lead Form

Fax Completed Form to: Meridian Bioscience

1-513-272-5421 ®

LeadCare II Placement Program Agreement

HbA1c and Glucose

Lipid Profile

ACTION: Sales Representative and Customer complete this form and forward to customer service with a purchase order for four (4) LeadCare II Test Kits. (Incomplete forms will result in a processing delay.) Program: Medline Item # M-BLCPlacement: This Placement Program is available only to customers who have not previously purchased a Meridian Bioscience, Inc. (“Meridian ”) LeadCare II Analyzer (Item # 70-6760) (“System”). The customer signing below (“Customer”) will receive one (1) System at no charge with the purchase of four (4) Meridian LeadCare II Test Kits (“Kits”) and the commitment to purchase at least eight (8) additional Kits each year thereafter. Each Kit contains forty-eight (48) tests. Customer may choose to return the System to Meridian at any time to terminate this Agreement and eliminate Customer’s commitment to order any further Kits. Medline and Customer hereby agree as follows. 1. Subject to the terms and conditions set forth in this Agreement and upon Customer’s purchase of four (4) Kits, Meridian shall place the System at Customer’s location as indicated below. 2. Commencing on the date of System installation and the purchase of four (4) Kits and continuing for the Term (as that term is defined in Section 5 below) of this Agreement, Customer shall purchase at least eight (8) Kits in each year (“Purchase Commitment”). Customer shall use its best efforts to meet its Purchase Commitment by making regular purchases of the Kits from Medline. Notwithstanding the foregoing, Customer shall be deemed to have breached its Purchase Commitment in the event Customer fails to purchase at least the minimum commitment amount of eight (8) Kits in a year. 3. Medline will invoice Customer for the Kits at the prices shown in the attached price list (“Prices”) and Customer shall pay for such Kits within Net 30 days. 4. Should Meridian determine that Customer has failed to meet its Purchase Commitment, Meridian shall have the right, but not the obligation to remove the System from Customer's facility. 5. This Agreement is in effect for as long as Customer retains the System and meets the minimum Purchase Commitment of eight (8) Kits in each year (“Term”). If Customer fails to purchase the agreed number of Kits by the end of each year of this Agreement, then Meridian shall have the right upon termination as set forth in Section 4 above. 6. The System involved in this Agreement shall remain the exclusive property of Meridian at all times and may be subject to inspection by an authorized Meridian representative at any time during the Term thereof. Notwithstanding Meridian’s ownership of the System, Customer shall be responsible for any damage to the System while in its possession. Customer shall use the System solely in conjunction with processing of the Kits and for no other purpose. The System while it is in the possession of Customer (except for reasonable wear and tear) shall maintain adequate damage insurance coverage with respect to the System. Medline shall have no obligation with respect to the operation or use of System. The parties are independent contractors, and neither party shall act or attempt to act, or represent itself as, an agent of the other party. 7. Customer agrees: (i) not to seek reimbursement from any private or public (e.g. Medicare or Medicaid) insurance for any product, meter or additional warranty service provided at no additional charge or at reduced charge by Medline ; or, in the alternative, if reimbursement is sought; (ii) to properly disclose and appropriately reflect discounts or price reductions, including items provided at no additional charge or at reduced charge by Medline , in such costs claimed or charges made for reimbursement, or in response to requests by government agencies for such price reduction and disclosure; and (iii) to be bound by Medline ’s standard terms and conditions contained on Medline ’s invoice(s) to Customer. Customer shall purchase the Kits for its own use and shall not resell or redistribute the Kits. 8. IT IS THE INTENT OF THE PARTIES TO ESTABLISH A BUSINESS RELATIONSHIP WHICH COMPLIES WITH THE MEDICARE AND MEDICAID ANTI-KICKBACK STATUTE SET FORTH AT 42 U.S.C. §1320a-7b(b). IN CERTAIN INSTANCES, INVOICES MAY NOT ACCURATELY REFLECT THE NET COST OF PRODUCT TO CUSTOMER. WHERE A DISCOUNT OR OTHER REDUCTION IN PRICE IS APPLICABLE, THE PARTIES ALSO INTEND TO COMPLY WITH THE REQUIREMENTS OF 42 U.S.C. §1320a-7b(b)(3)(A) AND THE “SAFE HARBOR” REGULATIONS REGARDING DISCOUNTS OR OTHER REDUCTIONS IN PRICE SET FORTH AT 42 C.F.R. §1001.952(h). IN THIS REGARD, THE PARTIES ACKNOWLEDGE THAT MEDLINE WILL SATISFY ANY AND ALL REQUIREMENTS IMPOSED ON SELLERS BY THE SAFE HARBOR AND CUSTOMER WILL SATISFY ANY AND ALL REQUIREMENTS IMPOSED ON BUYERS. THUS, CUSTOMER WILL ACCURATELY REPORT, UNDER ANY STATE OR FEDERAL PROGRAM WHICH PROVIDES COST OR CHARGE BASED REIMBURSEMENT FOR THE PRODUCTS AND SERVICES COVERED BY THIS AGREEMENT, THE NET COST ACTUALLY PAID BY CUSTOMER. 9. This Agreement merges or cancels all prior negotiations, understandings or supplemental agreements between the parties, oral or written, and constitutes the entire Agreement of the parties with respect to the subject matter hereof. This Agreement shall be executed simultaneously in one (1) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute and be the same instrument. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without any construction or interpretation against the party causing this Agreement to be made and may only be amended in a writing signed by both parties. All exhibits and attachments to this Agreement, and Medline ’s standard terms and conditions contained on Meridian ’s invoice(s) to Customer, form a part of this Agreement by reference. All notices shall be in writing, including notice of termination, and sent by certified mail, return receipt requested, or a commercial overnight courier to the addresses provided below.

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR

Note: The list price for the System is $ 2,440.00

Blood Gas

Customer Name Key Contact

Telephone (

Customer Installation Address

)

City

Customer Email

Fax (

State

Zip

Coagulation

)

I am fully aware of my state’s blood lead licensing and reporting requirements. Initials required Customer Signature Medline Rep Meridian Bioscience Rep Signature

Title Medline Rep Signature Title:

Meridian Bioscience | 3471 River Hills Drive, Cincinnati, Ohio 45244 | 800-305-0197 | www.meridianbioscience.com

Date

/

/

Date

/

/

Date

/

/

Cardiac LIS/Resources

MBI_LCII_Placement_Contract_Medline_2019-12

Forms


Lab Portfolio Placement Agreement

Quidel Triage Placement Agreement

Lab Lead Form HbA1c and Glucose

TRIAGE PLACEMENT AGREEMENT This Triage Placement Agreement (the “Agreement”) is entered into by and between Quidel Corporation, a Delaware corporation (“Quidel”), having a place of business at 12544 High Bluff Drive, San Diego, CA 92130 (“Quidel Notice Address”), and the customer set forth below (“Customer”).

Customer Information Facility Name Address City, ST, ZIP Primary Contact Phone E-Mail Fax Quidel Customer # 1.

“Sold To” (Notice Address):

“Ship To” (If different than Sold To):

Lipid Profile

Medline POC Influenza A & B / RSV

Distributor Rep

Distributor Account #

Strep

NATURE OF THE AGREEMENT. Quidel desires to sell to Customer and Customer desires to purchase from Quidel or its authorized distributor, as designated, (“Distributor”) certain tests used with the Triage Meter(s) (“Consumables”), as described herein. In addition, Quidel desires to provide to Customer, and Customer desires to use, Triage Meter(s) and ancillary components (the “Equipment”) for use with the Consumables during the Term of the Agreement (the “Equipment Use”). Title to the Equipment will remain with Quidel. For purposes of this Agreement, Consumables and Equipment (or Equipment Use), are collectively referred to as “Product” or “Products.”

2.

AGREEMENT TERM (“Term”). 36-Months commencing on the Effective Date.

3.

PURCHASE COMMITMENTS. In exchange for Quidel’s agreement to provide Customer with Equipment Use at no charge during the Term of this Agreement as indicated on Exhibit A attached hereto, Customer shall purchase the following Consumables in the following amounts and prices, and shall satisfy its total requirements (the “Annual Purchase Obligation”) for Consumables in each point of care immunoassay test category (e.g., natriuretic peptide) for the duration of the Term of the Agreement from Quidel. Catalog Number

Product

Customer Price Per Kit

Annual Purchase Obligation Tests $ (Dollar Amount)

Triage BNP Panel 25T

98000XR

$

$

Triage BNP Controls Level 1 - 5T

98013XR

$

$

Triage BNP Controls Level 2 - 5T

98014XR

$

$

Triage BNP Calibration Verification Set – 2 Sets/5T each

98015XR

$

$

Triage Cardiac Panel 25T Triage Cardiac Panel/BNP Combo 50T/2kts - one of BNP and Cardiac Triage Cardiac Panel/BNP, D DIMER Combo 75T/3kts one of BNP, D DIMER and Cardiac Triage Cardiac Panel TNI 25T Triage TNI+BNP+D DIMER Combo 75T/3kts - one of BNP, D DIMER and TNI Triage Cardiac Panel TNI/CK-MB 25T Triage TNI/CK-MB with BNP 50T/2kts – one of BNP and TNI/CK-MB Triage TNI/CK-MB with BNP+ D DIMER 75T/3kts – one of BNP, D DIMER and TNI/CK-MB

97000HS

$

$

97000B

$

$

97000BD

$

$

97021HS

$

$

97021BD

$

$

97022HS

$

$

97022B

$

$

97022BD

$

$

98100

$

$

88753

$

$

88754

$

$

88755

$

$

55069

$

$

Triage D-Dimer Panel 25T TRIAGE KIT, CONTROL Level 1, TC5 - includes BNP, D DIMER, CK-MB, MYO, TNI - 5 Vials per box TRIAGE KIT, CONTROL Level2, TC5 includes BNP, D DIMER, CKMB, MYO, TNI - 5 Vials per box Triage Total Calibration Verification 2 Sets/5T each – total 10T Triage Census ATM Software

Aggregate Annual Consumable Purchase Obligation:

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

$

If Quidel determines that Customer has not met the Annual Purchase Obligation at the end of any contract year, then Customer shall have 30 days from the end of the applicable annual period to meet the purchase commitments. If Customer fails to cure the Annual Purchase Obligation, then Quidel may, in its discretion, either: (i) raise pricing for the remaining Term of the Agreement based on volumes actually purchased or (ii) terminate the Agreement and cause Customer to (and Customer agrees that it shall) return all Equipment at Customer’s expense and pay to Quidel an amount equivalent to the depreciated value of the Equipment at the termination date using straight line depreciation and list price for the Equipment on the Effective Date. The

Triage Placement Agreement - 01.08.18 1/8/2018

Additional POC

Cardiac LIS/Resources Forms


Lab Portfolio Placement Agreement

Quidel Triage Placement Agreement

Lab Lead Form HbA1c and Glucose

parties acknowledge and agree that Quidel’s offer of the Equipment Use set forth in the following section to Customer at no charge is conditioned upon Customer’s purchase of the Consumables set forth herein for use with the Equipment. This Agreement, including the Additional Terms and Conditions, exhibits and addendums, attached hereto, is entered into on the Effective Date written below and has been executed by the authorized representatives of Quidel and the Customer. Customer:

Quidel Corporation

Authorized Signature:

Authorized Signature:

Name:

Name:

Title:

Title:

Date:

Effective Date:

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources

Triage Placement Agreement - 01.08.18 1/8/2018

Forms


Lab Portfolio Placement Agreement

Quidel Triage Placement Agreement

Lab Lead Form HbA1c and Glucose

Exhibit A EQUIPMENT USE Pursuant to Customer’s purchase commitments herein, Quidel shall provide Customer with Equipment, at no additional charge during the Term of this Agreement:

Product Description

Fair Market Value of Annual Use, per Unit

Quantity

Total Fair Market Value of Annual Use Provided to Customer (Unit Value x Quantity)

Triage MeterPro, item #55070MP

$1,399.00 each

$

Bar Code Scanner for Triage Meter BOM, item #52111

$133.33 each

$

Aggregate Fair Market Value of Annual Use of Equipment Provided to Customer:

Total Charge

No charge

Lipid Profile

Medline POC Influenza A & B / RSV

No charge

Strep $

*

No charge

* The value listed here reflects the annual discount amount associated with Customer’s annual purchases of Consumables for government reporting.

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Triage Placement Agreement - 01.08.18 1/8/2018

Forms


Lab Portfolio Placement Agreement

Quidel Triage Placement Agreement

Lab Lead Form HbA1c and Glucose

ADDITIONAL TERMS AND CONDITIONS

PURCHASES OF PRODUCTS THROUGH A DISTRIBUTOR ARE GOVERNED BY CUSTOMER’S AGREEMENT WITH THAT DISTRIBUTOR WITH RESPECT TO PAYMENT, SHIPMENT, RETURNED GOODS, AND WARRANTY TERMS. 1.

2.

3.

4.

5.

6.

ORDER PLACEMENT; DELIVERY AND SHIPMENT TERMS. Customer must submit firm written purchase orders for Consumables. No order shall be binding upon Quidel unless and until accepted by Quidel in writing. Customer shall not be entitled to revoke, reschedule, or cancel any purchase order after acceptance by Quidel without Quidel's written consent, which consent shall not be unreasonably withheld, conditioned or delayed. Quidel will use reasonable efforts to deliver accepted orders in accordance with its delivery schedule provided by the order acceptance, acknowledgment, confirmation or similar document, and if no such schedule is stated, promptly. All Products will be shipped by Quidel FOB Origin Quidel’s point of shipment. All packing, transportation expenses, handling charges, freight, and insurance (if any) shall be for the account of Customer, and Quidel shall charge Customer for all such charges, costs and expenses as a separate line item on Customer’s invoice. Quidel will select the mode of shipment and the carrier, but shall not be deemed thereby to assume any liability in connection with the shipment nor shall the carrier be construed as an agent of Quidel. Title to the Consumables and risk of loss, damage and delay to the Consumables will pass to Customer upon Quidel’s tender of delivery of the Consumables. Quidel shall not be obligated to procure additional insurance. CUSTOMER PRODUCT INSPECTION, ACCEPTANCE AND RETURNED GOODS POLICY. Customer shall be allowed five (5) days from the date of receipt of any order to provide a written notice of rejection to Quidel of any Product that (i) fails in a material way to meet the Limited Warranty set forth below, (ii) is damaged, (iii) has other visible defects, or (iv) is shipped in error. Otherwise, Customer shall be deemed to have accepted the Product as shipped. PRIOR TO RETURNING ANY PRODUCT, CUSTOMER MUST REQUEST A RETURN GOODS AUTHORIZATION NUMBER FROM QUIDEL (THE "RGA NUMBER") AND DELETE ANY AND ALL PHI STORED IN THE EQUIPMENT, INCLUDING PATIENT IDS AND ORDER NUMBERS. UNLESS QUIDEL HAS AUTHORIZED IN WRITING THE RETURN OF ANY PRODUCT, QUIDEL WILL NOT BE OBLIGATED TO ACCEPT, MAKE ANY EXCHANGE, REPLACE OR PROVIDE CREDIT OR REFUND FOR ANY PRODUCT RETURNED BY CUSTOMER. As promptly as practicable after written confirmation by Quidel of properly rejected Product and if Quidel desires that Customer return a Product, Customer shall return the same to Quidel freight prepaid. PAYMENT TERMS, PRICING AND TAX INFORMATION. Terms of payment are strictly net thirty (30) days from date of invoice. Prices set forth in the Agreement are guaranteed for one year from the date of this Agreement. Quidel or Distributor, as applicable, may increase prices by an amount not to exceed three percent (3%) or the applicable increase in the National Consumer Price Index (CPI), whichever is lower, in any year beyond the initial year of the Agreement. Customer’s obligation to pay outstanding invoices and all other amounts is absolute and unconditional and is not subject to any abatement, reduction, set-off, defense, counterclaim, interruption, deferment or recoupment for any reason whatsoever. All overdue payments shall bear interest at a rate of one and one-half percent (1.5%) per quarter or the maximum rate permitted by applicable law, whichever is lower, until paid. Unless Customer is fully exempt from all taxes, Customer shall reimburse Quidel or pay directly if requested by Quidel all federal, state and local taxes which may be imposed upon the use, possession, ownership and/or loan of the Consumables and/or Equipment. EQUIPMENT USE AND CONSUMABLES. Customer shall use Equipment (i) only in the United States or any territory of the United States at the Customer’s “ship to” address (unless Quidel consents to moving the Equipment to another location); (ii) for Customer’s “own use” and not for resale purposes; (iii) in the manner described in the User Manual, applicable Product labeling or according to Quidel’s instructions; and (iv) in accordance with all applicable law. Customer shall not make any changes or alterations in, or attachments to, the Equipment, or remove any labels, signs, symbols, trademarks, or serial numbers affixed to the Equipment. Customer may use Quidel Equipment only with Quidel Consumables. Notwithstanding the limited use of Equipment, Customer may purchase non-Quidel consumables for use with Equipment when such use is safe and appropriate with Quidel Equipment and medically necessary, upon patient request, or if, it is in the best interest of the patient. SERVICE AND TECHNICAL SUPPORT. Quidel shall provide service and maintenance for the Equipment (excluding network hardware) provided under this Agreement, during the Term of the Agreement, at no additional charge to Customer, provided that Customer fully complies with this Agreement. Prior to return of the Equipment to Quidel for service or maintenance, Customer must first delete any PHI stored locally on the Equipment. This Agreement does not cover service or parts for any attachments, accessories, or alterations not marketed by Quidel, nor to correct problems from their use. Throughout the term of this Agreement, Customer shall be responsible for routine maintenance of the Equipment, including replacement of batteries and all maintenance and cleaning set forth in the Maintenance and Cleaning section of the User Manual. Customer will be responsible for any damage to the Equipment caused by Customer’s negligent acts or omissions, or by any service performed by persons other than Quidel’s authorized dealer. Quidel reserves the right to use refurbished Equipment as replacement Equipment. Service includes software upgrades for reliability or operational improvements at no additional charge (excludes menu expansion). Technical support is provided for all Products provided directly from Quidel Corporation. LIMITED WARRANTY. QUIDEL WARRANTS THAT THE CONSUMABLES SHALL CONFORM SUBSTANTIALLY WITH THE SPECIFICATIONS SET FORTH IN THE RELATED PACKAGE INSERTS AND COMPLY WITH AND BE MANUFACTURED, PACKED, STERILIZED (IF APPLICABLE), LABELED AND SHIPPED IN MATERIAL COMPLIANCE WITH ALL APPLICABLE LAWS, RULES, REGULATIONS AND STANDARDS. QUIDEL WARRANTS THAT THE EQUIPMENT WILL BE MATERIALLY FREE FROM DEFECTS IN MATERIALS AND WORKMANSHIP FOR A PERIOD OF TWELVE (12) MONTHS FROM THE DATE OF SHIPMENT. QUIDEL’S SOLE LIABILITY AND BUYER’S SOLE REMEDY FOR BREACH OF THIS LIMITED WARRANTY, OR IN RELATION TO ANY DELAY OR DEFAULT IN SUPPLYING THE PRODUCTS, OR ANY OTHER CLAIM SHALL BE LIMITED TO, AT QUIDEL’S OPTION, THE REFUND OR CREDIT OF THE PRODUCT PRICE FOR SUCH PRODUCT (INCLUDING SHIPPING COSTS) OR REPAIR OR REPLACEMENT OF SUCH PRODUCT (WITH NEW AND/OR RECONDITIONED PARTS OR PRODUCTS) AT QUIDEL’S COST AND EXPENSE (INCLUDING SHIPPING). QUIDEL MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE, AND EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, WHETHER AS TO IMPLIED WARRANTIES OF TITLE, MERCHANTABILITY OR FITNESS OF THE PRODUCT FOR ANY PARTICULAR PURPOSE, INTEROPERABILITY, OR NON-INFRINGEMENT, OR ANY OTHER MATTER. QUIDEL DOES NOT WARRANT, GUARANTEE, OR MAKE ANY REPRESENTATIONS THAT THE PRODUCT SOFTWARE IS ERROR-FREE OR WILL OPERATE WITHOUT INTERRUPTION. QUIDEL’S MAXIMUM LIABILITY FOR ANY CUSTOMER CLAIM ARISING FROM THIS AGREEMENT SHALL NOT EXCEED THE NET PRODUCT PRICE PAID BY CUSTOMER. IN NO EVENT SHALL EITHER PARTY OR ITS AFFILIATES BE LIABLE FOR ANY INCIDENTAL, INDIRECT, SPECIAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES, INCLUDING, BUT NOT LIMITED TO, DAMAGES FOR LOSS OF USE OR REVENUE, OR PROFITS IN CONNECTION WITH OR ARISING OUT OF QUIDEL’S PROVISION OF ANY PRODUCTS, OR CUSTOMER'S USE OF ANY PRODUCTS PROVIDED BY QUIDEL OR DAMAGE TO SYSTEMS, PROGRAMS, OR DATA, COST OF PROCUREMENT OF SUBSTITUTE GOODS, SERVICES, OR TECHNOLOGY, EVEN IF THE PARTIES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE LIMITED WARRANTY CONTAINED HEREIN DOES NOT APPLY TO EQUIPMENT DAMAGED THROUGH ABNORMAL USE, MISUSE, MISHANDLING, NEGLECT, ACCIDENT, NEGLIGENCE, TAMPERING OR UNAUTHORIZED SERVICE. THE TERMS SET FORTH HEREIN PURSUANT TO WHICH

Triage Placement Agreement - 01.08.18 1/8/2018

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


Lab Portfolio Quidel Triage Placement Agreement

Placement Agreement

Lab Lead Form

QUIDEL AGREES TO PROVIDE PRODUCT TO CUSTOMER REFLECT THE PARTIES' AGREED UPON ALLOCATION OF RISK AND LIMITATIONS HEREIN SHALL APPLY EVEN IF ANY LIMITED REMEDY FAILS IN ITS ESSENTIAL PURPOSE. 7. COMPLIANCE WITH LAWS AND DISCOUNT REPORTING. The parties shall comply with applicable state and federal laws in the performance of this Agreement, including, without limitation, the federal False Claims Act (31 U.S.C. §§ 3729 et seq.), the federal anti-kickback statute (42 U.S.C. § 1320a7b(b)), the federal Physician Payment Sunshine Act (the “AKS”, 42 U.S.C. § 1320a-7h), the Health Insurance Portability and Accountability Act of 1996 and the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”), and any regulations implementing such laws, as well as all comparable state and local laws and regulations. Any discounts provided in connection with the sale of products are intended to comply with the AKS. Customer shall fully and accurately report in applicable cost reports and other submissions to federal healthcare programs all discounts provided and, upon request of the Secretary of the U.S. Department of Health and Human Services or a state agency, shall make available information provided to Customer by Supplier concerning the discounts. Customer acknowledges that compliance with the AKS exception or regulatory safe harbor for discounts, including the reporting obligations, is a condition precedent for the sale of products and that Supplier would not have agreed to sell products hereunder had Customer not agreed to comply with such obligations. Customer acknowledges and agrees that Quidel is not a HIPAA Business Associate to Customer. Customer acknowledges and agrees that Quidel has the authority, in its sole and absolute discretion, to recall any Product to comply with applicable laws, and Customer agrees to fully cooperate with Quidel in the case of any such recall. 8. NON-DEBARRMENT/EXCLUSION. Each party represents and warrants that neither it, nor any of its directors, employees, or agents, has ever been barred or excluded from participating in any federal or state health care program, or convicted of a criminal offense with respect to health care reimbursement. Each party shall immediately notify the other party if the foregoing representation becomes untrue, or if either party is notified by the Office of Inspector General of the Department of Health and Human Services or other enforcement agency that an investigation of the party or any of its directors, employees, or agents has begun which could lead to such debarment, exclusion, or conviction. In the event that either party or any of its directors, employees, or agents is debarred or excluded from participating in any federal or state health care program during the term of this Agreement, or if at any time after the Effective Date of this Agreement it is determined that either party is in breach of this section, this Agreement shall, as of the effective date of such debarment or exclusion be automatically terminated. 9. TERMINATION. Either party may terminate this Agreement following a default by the other party of its obligations hereunder if such default is not cured within thirty (30) days after delivery of notice of such default to the defaulting party or the other party files a petition in bankruptcy, is adjudicated bankrupt, makes a general assignment for the benefit of creditors, or is voluntarily or involuntarily dissolved. If neither party provides prior written nonrenewal notice to the party at least sixty (60) days prior to the end of the Term, then the Term shall be automatically extended for twelve (12) months. Upon termination of this Agreement, Customer will carefully pack and ship the Equipment to Quidel in substantially the same condition as received (ordinary wear and tear excepted) in accordance with the terms herein. If the Equipment is returned, Customer shall be responsible for: (i) deleting any and all PHI (within the meaning of HIPAA) stored in the Equipment, including all Patient IDs and Order Numbers; (ii) the loss of or damage to the Equipment including while it is in return transit; and (iii) the transportation expenses for the return of the Equipment. 10. DISTRIBUTOR. Customer, at its sole discretion, may select a Distributor of its choice. Quidel may delegate to Distributor any of Quidel’s duties pertaining to distribution of Products or related activities under the Agreement. Customer acknowledges and consents to such delegation to Distributor. Any reference to Quidel in the Agreement that imparts on Quidel any duty that Quidel has delegated to Distributor shall be construed as a reference to Quidel or to Distributor. The terms and conditions contained in any invoice, sales acknowledgement, bill of lading, or other document supplied by Distributor to Customer shall (a) govern the relationship between Distributor and the Customer and (b) supersede any inconsistent terms and conditions of the Agreement and any addendum or exhibits attached hereto, with respect to the terms of shipment and payment for Products delivered to the Customer by the Distributor, which terms include, without limitation, acceptance, damage or loss in transit, credit terms, payment terms, and shipping terms, but exclude any warranty terms (which warranty terms shall be solely as expressly set forth in this Agreement). For the avoidance of doubt, pricing terms and purchase commitments for the Consumables and Equipment are as set forth in this Agreement. 11. GRANT OF LIMITED SOFTWARE LICENSE. To the extent applicable, Quidel grants Customer a limited, non-exclusive, non-transferable license to use software (“Software”) during the Term. Customer shall (i) use Software only as an integrated part of a Product and shall not separate integrated Software from any Product; (ii) not translate, disassemble, decompile, reverse engineer, alter or modify the Software; (iii) not make any copies of the Software except one (1) copy for back-up purposes; and (iv) use Software only for during the Term. The Software is owned or licensed by Quidel and is protected by copyright and other laws. Customer shall not sell, assign, sublicense, transfer or disclose or permit access to the Software to a third party. 12. MISCELLANEOUS. Quidel shall not be liable for nonperformance or delays caused by a shortage of raw materials, manufacturing problems, delivery or labor problems, priorities, acts of regulatory agencies or judicial bodies, discontinuation of a product line, acts of God or third parties, infringement claims, or other causes beyond its reasonable control. Customer agrees that in such events Quidel may allocate Products among all purchasers as it deems reasonable, without liability. This Agreement, including any addenda or exhibits, contains the entire understanding with respect to the subject matter of this Agreement and supersedes all prior written and oral agreements, proposals, and representations made between the parties. No changes to this Agreement shall be made or be binding upon either party unless made in writing and signed by both parties. No right created under this Agreement shall be waived unless expressly waived in writing and signed by the party possessing such right. This Agreement shall be governed by the laws of the state of California, without regard to any conflicts of law provision. The non-prevailing party in any claim arising from this Agreement shall pay the prevailing party reasonable attorneys’ fees and expenses incurred in such claim. Customer agrees not to disclose the terms and conditions of this Agreement to any person except as required by law upon receipt of Quidel’s prior written consent. Customer warrants that it will not, and will not permit or assist any other person or entity to, divulge, disclose, or in any way distribute or make use of Quidel trade secrets or intellectual property, and that it will not, and will not engage, permit or assist any other person or entity to, modify, reverse engineer or manufacture Products herein. If any law or court of competent jurisdiction makes any provision of the Agreement illegal, invalid or unenforceable, then the remaining terms and conditions shall remain in effect. Any notice between the parties shall be in writing and shall be deemed given only if delivered personally, by registered or certified mail, return receipt requested, or by overnight delivery to the Quidel Notice Address set forth in this Agreement, if given to Quidel, and the Customer Notice Address set forth in this Agreement, if given to Customer. Notices shall be deemed effective upon receipt. Either party may assign this Agreement in connection with the transfer or sale of a majority of its assets or stock from a merger, consolidation or change of control. Otherwise, Customer may not assign or transfer this Agreement, nor move, transfer, or assign the Equipment without Quidel’s prior written consent.

HbA1c and Glucose

Lipid Profile

Medline POC Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources

Triage Placement Agreement - 01.08.18 1/8/2018

Forms


Lab Portfolio Placement Agreement

Quidel Triage Placement Agreement

Lab Lead Form HbA1c and Glucose

Ship To Addendum This addendum permits Quidel to accept purchase orders from the following Customer “Ship To” entities referenced below, and permits Quidel to ship products directly to such entities. Customer represents that it has the authority to bind each entity to this Agreement, and each entity shall be bound by this Agreement, as if such entity signed this Agreement. Each entity shall be obligated for their purchases made pursuant to this Agreement. Participating Sites: Membership ID

Territory ID

Account Number

Account Name

Lipid Profile

Medline POC Address

City

St

Zip

Influenza A & B / RSV

Strep

Additional POC

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Triage Placement Agreement - 01.08.18 1/8/2018

Forms


Lab Portfolio Placement Agreement

DCA Vantage Analyzer Starter Kit Agreement

Lab Lead Form HbA1c and Glucose

Lipid Profile

2020 DCA Vantage® Analyzer Starter Kit Program Agreement 2018 DCA Vantage® Analyzer Starter Kit Program Agreement Promotion Codes: STARTA1C/STARTA1C5 (Jan. 1, 2020 to Dec. 31, 2020) Promotion Codes: STARTA1C/STARTA1C5 (Jan. 1, 2018 to Dec. 31, 2018)

Medline POC

Complete Completethis thisform formand andfax faxtotoSiemens SiemensCommercial CommercialServices Services(888) (888)242-9448 242-9448 OR OREmail Emailto: to:dxus.csdistributors.team@siemens-healthineers.com. customerservicedistributors.healthcare@siemens.com

Ship to Entity (“Customer”) Ship to      Entity (“Customer”)

Account Name Contact Name and Title Legal Name Address (Street#, Name) Address (City, State, Zip) Address (City)Name and Title Contact Address (State, Email and Zip) Phone No. Email Date PhoneSiemens No. Sales Rep Name Siemens Sales Rep#

Influenza A & B / RSV

Bill to Entity (“Distributor”)       Distributor Information

Distributor Name Distributor Rep Name       Distributor Name Email Distributor and PhoneRep No. Name       Distributor # Phone No.       EmailPO and Distributor Customer       Distributor PO #Acct. # Date: Distributor Customer Acct #

Strep

Check the desired warranty

Additional POC

theCODE: desired warranty 36 months of analyzer warranty at no chargeCheck (PROMO STARTA1C) 36 months of analyzer warranty at no charge (PROMO CODE: STARTA1C) 60 months of analyzer warranty at a promotional price of $250 will be added to the analyzer price of $2000 (PROMO CODE: STARTA1C5) 60 months of analyzer warranty at a promotional price of $250 will be added to the analyzer price of $2000 (PROMO CODE: STARTA1C5) Enter the desired analyzer quantity

.

Siemens Healthcare Diagnostics Inc. (“Siemens”) agrees to sell to the Distributor for a price of $2,000.00 and to ship to the Customer indicated above, a DCA Vantage® Analyzer (Siemens Item No. 5075US) valued at $2995.00 (the "Instrument”) in accordance with 1. Siemens Inc. (“Siemens”) agrees to agreement sell to the Distributor for Agreement”) a price of $2,000.00 to ship to theSiemens Customer indicated theHealthcare applicableDiagnostics provisions of that certain distribution (“Distribution betweenand Distributor and and the above, terms a DCA Vantage® Analyzer (Siemens InItem No. at the $2995.00 “Instrument”) accordancethe withterms the applicable herein (“Purchase Agreement”). case of 5075US) a conflictvalued between terms (the of the respective in Agreements, of the provisions of that certain distribution agreement (“Distribution Agreement”) between Distributor and Siemens and the terms herein (“Purchase Distribution Agreement shall control. Agreement”). In case of a conflict between the terms of the respective Agreements, the terms of the Distribution Agreement shall control. 2. Provided herein at no additional charge are 1 DCA HbA1c Reagent Kit (Siemens item No. 5035C) valued at $84.50 and 1 DCA HbA1c Control (Siemens item No. valuedReagent at $90.58. to purchase directlyatfrom Siemens, useHbA1c by 2. Provided herein at no Kit additional charge are 15068A) DCA HbA1c KitDistributor (Siemensagrees item No. 5035C) valued $84.50 and 1 for DCA DCA item HbA1c Kit products at the net rebated cost of $50.00 for the Term of by this Purchase ControlCustomer, Kit (Siemens No. Reagent 5068A) valued at $90.58. Distributor agrees contract to purchase directly from Siemens, for use Customer, DCA contract costnet herein is not transferable to $50.00 any other distributor thisPurchase Customer. Customer’sThe name and address HbA1cAgreement. Reagent Kit The products at the rebated contract cost of for the Term offorthis Agreement. contract cost herein must match to forany proper processing charge back claims. is not transferable other distributoroffor this Customer. Customer’s name and address must match for proper processing of charge back 3. The term of this Purchase Agreement is thirty-six (36) months (“Term”) and shall commence thirty (30) days after shipment of the claims. Instrument to the Customer. Distributor shall submit sales tracing to Siemens sufficient for Siemens to verify 3. The term of this Purchase Agreement is thirty-six (36) months (“Term”) and shall commence thirty (30) days after shipment of the Instrument to rebates/chargebacks. the Customer. Distributor shall submit sales tracing to Siemens sufficient for Siemens to verify rebates/chargebacks. 4. Subject to the provisions of Paragraph 2, Siemens will provide full service on the Instrument, valued at $979.00 annually, as per 4. Subject to the provisions of Paragraph 2, Siemens will provide full service on the Instrument, valued at $979.00 annually, as per the the warranty coverage selected above in accordance with Siemens’ standard service policy. warranty coverage selected above in accordance with Siemens’ standard service policy. 1.

5. 6.

5. This Purchase Agreement is subject to acceptance by Siemens. This Purchase Agreement is subject to acceptance by Siemens. 6. Distributor agrees (i) not to seek reimbursement from any private or public (e.g., Medicare or Medicaid) insurance for any Reagent Kit or service charge or at reduced or, Medicare in the alternative, (ii) toinsurance properly for disclose and appropriately Distributor agreesat (i)no notadditional to seek reimbursement from anycharge privatebyorSiemens; public (e.g., or Medicaid) any Reagent Kit or service reflect discounts reductions, including items provided no additional or atdisclose reducedand charge by Siemens, in such costs or at no additional charge or or price at reduced charge by Siemens; or, in theatalternative, (ii) charge to properly appropriately reflect discounts claimed orincluding chargesitems madeprovided for reimbursement, or in response to requests by government for such price reductionmade and for price reductions, at no additional charge or at reduced charge by Siemens, agencies in such costs claimed or charges disclosure. reimbursement, or in response to requests by government agencies for such price reduction and disclosure.

Urinalysis Hematology

Chemistry

Immunoassay

Specialty

ESR

Chargebacks must submitted using the customer’s name and address indicated above. Chargebacks must bebe submitted using the customer’s name and address asas indicated above.

Blood Gas Coagulation

Cardiac LIS/Resources

2018 DCA Vantage Starter Kit Program Agreement_BLANK[3].doc

Page 1 of 1

Forms


Lab Portfolio Placement Agreement

DCA Vantage Analyzer Placement Agreement

Lab Lead Form HbA1c and Glucose

Lipid Profile

2020 DCA Vantage® Analyzer Placement Program Agreement Promotion Codes: 1, 2020 toAgreement Dec. 31, 2020) 2018 DCAPLACEDCA/PLACEDCA5 Vantage® Analyzer Starter(Jan. Kit Program Promotion STARTA1C/STARTA1C5 (Jan. 1,Services 2018 to(888) Dec.242-9448 31, 2018) Complete Codes: this form and fax to Siemens Commercial

Medline POC

OR Email to: dxus.csdistributors.team@siemens-healthineers.com Complete this form and fax to Siemens Commercial (888) 242-9448 Ship to Entity (“Customer”) Bill to EntityServices (“Distributor”)       Distributor Name       OR Email to: customerservicedistributors.healthcare@siemens.com

Account Name Contact Name and Title       Address (Street #, Name) Ship      to Entity (“Customer”) Address (City)       Legal Name Address (State, Zip) Address (City, State, Zip)       Email Contact Name and Title       Phone No.       Email and Phone No. Siemens Date Sales Rep.       Siemens Sales Rep Name

Distributor Rep Name Email and Phone No. DistributorDistributor PO # Name DistributorDistributor CustomerRep Acct# Name Date Email and Phone No.

Influenza A & B / RSV

Distributor Information

Strep

Distributor PO # Distributor Customer Acct #

Check CheckOne theTier desired warranty

Minimum of 4ofper monthwarranty of DCA HbA1c #5035C priced atCODE: $65.00STARTA1C) per box and / or Microalbumin/ Creatinine Reagent Kits #6011A priced at 36 months analyzer at no charge (PROMO $65.00 per box (in any combination) 60 months of analyzer warranty at a promotional price of $250 will be added to the analyzer price of $2000 (PROMO CODE: STARTA1C5) Minimum of 8 per month of DCA HbA1c #5035C priced at $63.86 per box and / or Microalbumin/ Creatinine Reagent Kits #6011A priced at Tier 2       $62.00 per box (in any combination) 1. SiemensMinimum Healthcare Diagnostics Inc. (“Siemens”) agrees to sell to the for a price of $2,000.00 and priced to ship to the Customer of 12 per month of DCA HbA1c #5035C priced at $57.75 per box and /Distributor or Microalbumin/ Creatinine Reagent Kits #6011A Tier 3       indicated a box DCA Vantage® Analyzer (Siemens Item No. 5075US) valued at $2995.00 (the "Instrument”) in accordance with at above, $62.00 per (in any combination) Minimumprovisions of 20 per month of DCA HbA1c #5035C priced agreement at $54.00 per box and / or Microalbumin/ Creatinine Reagent Kits #6011A priced the applicable of that certain distribution (“Distribution Agreement”) between Distributor and Siemens and the Tier 4       at $62.00 per box (in any combination) terms herein (“Purchase Agreement”). In case of a conflict between the terms of the respective Agreements, the terms of the Tier 1

2.

Distribution Agreement shall control.

Urinalysis

Check the desired warranty

36 months of analyzer warranty at no charge (PROMO CODE: PLACEDCA) Provided herein at no additional charge are 1 DCA HbA1c Reagent Kit (Siemens 60 months of analyzer warranty at a promotional price of $250 (PROMO CODE: PLACEDCA5)

item No. 5035C) valued at $84.50 and 1 DCA HbA1c Control Kit (Siemens item No. 5068A) valued at $90.58. Distributor agrees to purchase directly from Siemens, for use by Enter the desired analyzer quantity Customer, DCA HbA1c Reagent Kitplaced. products at the net rebated contract cost of $50.00 for the Term of this Purchase       Note that reagent commitment is per analyzer Agreement. The contract cost herein is not transferable to any other distributor for this Customer. Customer’s name and address 1. Siemens Healthcare Diagnostics Inc. (“Siemens”) agrees to place the DCA Vantage Analyzer (“Instrument”) valued at $2995 per system at the Customer location indicated match for proper processing of charge claims. abovemust in accordance with the applicable provisions of thatback certain distribution agreement (“Distribution Agreement”) between Distributor and Siemens and the terms herein 3. The term of this In Purchase Agreement is the thirty-six months Agreements, (“Term”) and shall ofcommence thirty (30) days shipment of the (“Placement Agreement”). case of a conflict between terms of (36) the respective the terms the Distribution Agreement shall after control. Instrument to the Customer. Distributor shall submit sales tracing to Siemens sufficient for Siemens to verify 2. Distributor agrees to purchase the minimum quantity of Reagent Kits designated above from Siemens during the Agreement Term (“Commitment Amount”) for shipment each rebates/chargebacks. month from its inventory to the Customer identified above. The contract cost as stated above is not transferable to any other distributor for this Customer. 3.

Additional POC

4. Subject tothis thePlacement provisions of Paragraph 2, Siemens provide fullshall service on the Instrument, valued atof$979.00 annually, as per Upon The initial term of Agreement is thirty six (36) monthswill (“Initial Term”) and commence thirty (30) days after shipment the Instrument to the Customer. the warranty selected above in accordance Siemens’ service policy. to Distributor. Further, this Placement Agreement shall completion of the Initialcoverage Term and subject to the provisions of paragraph with 2, Siemens shallstandard pass title of the Instrument

automatically renew on a yearly basis (each, a “Renewal Term”) until terminated by either party as provided for herein. The total term of this Placement Agreement shall be the 5. Purchase Agreement is subject to acceptance by Siemens. Initial This Term plus any Renewal Terms (“Term”). On January 1 of any calendar thereimbursement Term, Siemens may increase the pricesorforpublic Reagent Kits Medicare specified herein, up to five (5) percent. Siemens notify Distributor in 6. Distributor agrees (i)year not during to seek from any private (e.g., or Medicaid) insurance for any will Reagent Kit writingoratservice least 30 days the effective dateor of any such pricecharge increase.by Siemens; or, in the alternative, (ii) to properly disclose and appropriately at nobefore additional charge at reduced discounts price reductions, including items provided noduring additional charge orthe at other reduced charge by Siemens, in such costs 5. Eitherreflect party may terminateor this Placement Agreement for its convenience at any at time the Term by giving at least thirty (30) days prior written notice of its intent claimed to do so. The of termination of this Placement shall be the last calendar day of the month in which of termination is given and to the other or effective chargesdate made for reimbursement, orAgreement in response to on requests by government agencies fornotice such price reduction party. disclosure. In the event of termination during the Initial Term at either the request of the Distributor or by Siemens, Distributor shall have the responsibility to retrieve the Instrument

Hematology

Chemistry

Immunoassay

4.

from Customer and return the Instrument to Siemens within forty five (45) days of the effective date of such termination. Distributor must obtain authorization from Siemens to return such Instruments by calling 1-877-885-4873. A return authorization number must accompany each returned Instrument. Distributor will be responsible for the costs of the proper packing, the proper storagemust (if applicable), and the freight charges associated with returning Instrument Siemens. above. Chargebacks be submitted using the customer’s name andthe address astoindicated

6.

Distributor shall provide Siemens with sales tracing sufficient for Siemens to determine whether volume commitments are being met by customer. If during the Term, it is determined by Siemens that actual average monthly Reagent Kits is less than the Commitment Amount, then Siemens shall change the prices for Reagent Kits herein to the price that corresponds to the Tier pricing for the actual volume of Reagent Kits purchased. If the actual average monthly Reagent Kits purchased is less than the volume in Tier 1, then; ·

During the Initial Term - Siemens may terminate this Placement Agreement, effective on the thirtieth day after notification. Distributor shall either return the Instrument to Siemens pursuant to paragraph 5 above or purchase the analyzer at its fair market value.

·

During the Renewal Term - This Placement Agreement shall expire at the end of the then-current contract year and shall not automatically renew. Distributor is not required to return the Instrument to Siemens.

7.

The Instrument involved in this Placement Agreement shall remain the property of Siemens for the Initial Term of this Agreement. The Distributor shall be responsible for risk of loss and damage to the Instrument during the Initial Term. Siemens shall have no obligation with respect to operation or use of Instrument other than that specified in the operation manual which accompanies the Instrument.

8.

Subject to the provisions of Paragraph 2, Siemens will provide full service on the Instrument, valued at $979.00 annually as per the warranty coverage selected above in accordance with Siemens’ standard service policy.

9.

This agreement is subject to acceptance by Siemens.

10. Distributor agrees (i) not to seek reimbursement from any private or public (e.g., Medicare or Medicaid) insurance for any Reagent Kit or service provided at no additional charge or at reduced charge by Siemens; or, in the alternative, (ii) to properly disclose and appropriately reflect discounts or price reductions, including items provided at no additional charge or at reduced charge by Siemens, in such costs claimed or charges made for reimbursement, or in response to requests by government agencies for such price reduction and disclosure. Chargebacks must be submitted using the customer’s name and address as indicated above.

2018 DCA Vantage Starter Kit Program Agreement_BLANK[3].doc

Page 1 of 1

Specialty

ESR Blood Gas Coagulation

Cardiac LIS/Resources Forms


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