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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
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Siemens DCA Vantage Albumin & Creatinine AMV6011Z | 10 ea/bx L20.8.60.5.17 82044QW & 82570QW $11.41
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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�* �������
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Blood Gas Coagulation
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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� �� ����� ����� �� ��� ������� � �������, ����������, ��� ��� ����� �� ����� �� ����� �������
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Simple to Use � �� ������ �� ������� ����������� �������� � ���� ��������� ���� ������ ���� ������ ��� ���� ���� � ������������� ��������� ������� Flexible Patient Data Management � ����� �� ������� ��/���� ��� �������� �� ���� ����� ������ �� �������� ������� � �������� ������ ���������� ��������, ��������� ������� ������� ������, �������� �������, ���/�� �������� �� ���/��� � ������� ������ �� �000 ������� ���� �������� ������� ������������ � ���� �������� �� ������� �������� ���� ��� ����� ����� �� ��
Are you effectively monitoring diabetes complications? ��� ������� �������� �������� ��� ��-����� �������, ����������, ��� ��� ����� ������� ���� ���-������� ����������� ��� �����������. ������ ����, ���� �� ������� ��� ���������� ��� ����� ��� ��������, �� ����� ���� � ������� ��� ������ ������ ������� ������� � ������� ������� ���� � ��������� ����
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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 ������� ������� ��������� ����������� ������ � ����� ��������� �� �����������-������ ���������� ��������� ���� ������� ���� ��������� ���� �� ������ �� ��� ���������, ����������, ��� ���������� �� �������. ��� �������� ��� �������� ����� �������� ��� ����� ������� �� �������, ����������, ��� ������������ ������ ��� ���������� ��������� �� ������� ������� ������������� ���� ��� ����� ����������� ���� ���� �� ������� ������, ���� ������������ ���� �� �������� ������ ��� �����.
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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
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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
medlinemexico.com | mexico@medline.com
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
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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
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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
ESR
• Autoveri is based
• Integrate a user-de
• Software
Blood Gas later revi
Increase Coagulation• Continuo
centrifug manual s
Cardiac • Minimize
• You can and com LIS/Resourcesother du
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
The pro
and ma automa flow cy
• Autom flagge
ESR
• Reliab of nor manu
Blood Gas
See a C
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
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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
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The Smart Choice for POLs
N
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• Maintain control and compliance—Automated quality control checks on every test
ASSAYS TO MEET A WIDE RANGE OF CLINICAL NEEDS
MPREHE CO
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• 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
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• 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
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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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.
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)
Influenza A & B / RSV
Strep
Additional POC Urinalysis
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
Specialty
ESR Blood Gas
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
HbA1c and Glucose
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Welcome to the
SMART LAB Reliable. Accurate. Results.
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Hematology Chemistry Immunoassay
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ACE Axcel® Clinical Chemistry System
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Reliable. Accurate. Results.
Intelligence for the Physician Office Lab
Check Reagent Strep Status
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.
Additional POC
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
Blood Gas
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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
Additional POC Urinalysis
• 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
Specialty
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
Blood Gas
Coagulation Cardiac
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Over A Decade of Award-Winning Customer Service
Strep
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
Specialty
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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Reliable. Accurate. Results.
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ACE Axcel® Clinical Chemistry System
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Test Menu
Cardiovascular Risk Assessment
Cholesterol High Density Lipoprotein Cholesterol
Influenza A & B / RSV
Low Density Lipoprotein Cholesterol Triglycerides
Diabetes
Additional POC
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
HbA1c and Glucose
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Additional POC Urinalysis
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Lab Portfolio Siemens Dimension EXL Family + Test Menu
Lab Lead Form HbA1c and Glucose
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Additional POC
Urinalysis Hematology
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.
Immunoassay
Specialty
ESR Blood Gas
www.siemens.com/diagnostics
Coagulation
Cardiac LIS/Resources
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.
Specialty
ESR Blood Gas Coagulation
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2
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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
Specialty
• 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
Immunoassay
Specialty
ESR
How LOCI chemiluminescent technology works:
Blood Gas
Analyte
Chemibead
Influenza A & B / RSV
Additional POC
% 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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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:
HbA1c and Glucose
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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 ®
Urinalysis
*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.
Immunoassay
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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.
Blood Gas Coagulation
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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Chemistry Immunoassay
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Atellica Solution + Test Menu
Transform care delivery with the power of the Atellica Solution
HbA1c and Glucose
The Atellica Solution i
Lipid Profile automation-ready imm
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
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siemens.com/atellicasolution
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Atellica Solution + Test Menu
HbA1c and Glucose
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Medline POC Influenza A & B / RSV
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
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Cardiac LIS/Resources Forms
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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HbA1c and Glucose
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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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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
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The DxC 700 AU analyzer supports laboratory excellence by: Enhancing clinical effectiveness through reliable results
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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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Hematology
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.
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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
Influenza A & B / RSV
with input from clinical laboratorians
›
Real-time status alerts, notifying operators of conditions that could affect sample processing
›
Strep
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
LIS/Resources Forms
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
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Strep
Additional POC Urinalysis
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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Lab Portfolio Horiba Pentra 400 Chemistry Analyzer
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Horiba Pentra 400 Chemistry Analyzer
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Lab Portfolio Horiba Pentra 400 Chemistry Analyzer
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Lab Portfolio Horiba Pentra 400 Chemistry Analyzer
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Horiba Pentra 400 Chemistry Analyzer
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Lab Portfolio Medtest BS-200 Chemistry Analyzer
Lab Lead Form HbA1c and Glucose
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Lab Portfolio Diatron Pictus 500
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P500 INTELLIGENT WALK AWAY CHEMISTRY
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Diatron Pictus 500
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INTELLIGENT WALK AWAY CHEMISTRY
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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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P500
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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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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
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Hematology Chemistry Immunoassay
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Coagulation RELIABILITY & TRUST Diatron manufactures high performance analysers with best available quality components
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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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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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Pictus 700 THE SMART CHOICE FOR TODAY’S LABORATORY
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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
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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
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Coagulation MULTIFUNCTIONAL PROBES • Clot, crash and liquid detection on both probes • Pre-heated probe for faster test times • Variable intensity mixer
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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)
Strep
MEDICA ISE MODULE
Reaction
• Reaction temperature: 37 °C +/- 0.1 °C
Influenza A & B / RSV
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
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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
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LIS/Resources Forms
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
LIS/Resources Forms
Lab Portfolio Lab Lead Form
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
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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.
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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
Lab Portfolio Lab Lead Form
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
LIS/Resources Forms
Lab Portfolio Lab Lead Form
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
LIS/Resources Forms
Lab Portfolio Lab Lead Form
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
LIS/Resources Forms
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
Lab Portfolio Lab Lead Form
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
Cardiac LIS/Resources Forms
Lab Portfolio Lab Lead Form
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
Cardiac LIS/Resources Forms
Lab UniCel DxI The Portfolio DESIGNED WITH YOUR NEEDS IN MIND Beckman Coulter UniCel DxI
Lab Lead Form
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
Lab Portfolio Lab Lead Form
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
Cardiac LIS/Resources Forms
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
Cardiac LIS/Resources Forms
Lab Portfolio Lab Lead Form
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
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Immunoassay
Specialty
ESR Blood Gas Coagulation
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Lab Portfolio Beckman Coulter UniCel DxI
Lab Lead Form HbA1c and Glucose
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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
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ESR Blood Gas
Minimize Your Challenges Today, Before They Magnify Tomorrow ADVIA Centaur® CP Immunoassay System
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Tomorrow, You’ll Have Less Time, Space, and Staff. Are You Prepared to Face the Challenge?
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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
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Siemens ADVIA Centaur CP
HbA1c and Glucose
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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
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HbA1c and Glucose
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Medline POC Influenza A & B / RSV
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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
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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
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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
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ESR Blood Gas Coagulation
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Lab Portfolio Siemens ADVIA Centaur Test Menu
Lab Lead Form HbA1c and Glucose
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Medline POC Influenza A & B / RSV
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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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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
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Additional POC
Urinalysis Hematology
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Maximize Your Laboratory’s Potential
Specialty
ESR
IMMULITE 2000 XPi Immunoassay System Blood Gas
siemens-healthineers.com Coagulation
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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
Cardiac• Provides ro
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
LIS/Resources Forms
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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
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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
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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
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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
Forms
Lab Portfolio Diatron GEMINI
Lab Lead Form HbA1c and Glucose
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
LIS/Resources Forms
Lab Portfolio Lab Lead Form
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
LIS/Resources Forms
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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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Specialty Cepheid GeneXpert®
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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Lab Portfolio Cepheid GeneXpert
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Strep
Additional POC Urinalysis
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Specialty
ESR Blood Gas
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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HbA1c and Glucose
Lipid Profile Medline POC Influenza A & B / RSV
Strep
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Immunoassay
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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HbA1c and Glucose
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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”.
ESR Blood Gas
Coagulation Cardiac
LIS/Resources 4
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ESR Blood Gas
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LIS/Resources GAME CHANGER : CEPHEID GENEXPERT SYSTEM
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HbA1c and Glucose
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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
Hematology Chemistry
Immunoassay
Specialty
ESR Blood Gas
Coagulation Cardiac
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HbA1c and Glucose
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
Coagulation Cardiac
LIS/Resources GAME CHANGER : CEPHEID GENEXPERT SYSTEM
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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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Lab Portfolio Cepheid GeneXpert
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LIS/Resources GAME CHANGER : CEPHEID GENEXPERT SYSTEM
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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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HbA1c and Glucose
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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.
Cardiac
LIS/Resources A better way.
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HbA1c and Glucose
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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
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PHONE FAX
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MOLECULAR. SOLUTIONS.
Influenza A & B / RSV
Strep
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
LIS/Resources Quidel | Molecular Diagnostics | quidel.com | 800.874.1517 | 858.552.1100
Forms
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Quidel Solana
HbA1c and Glucose
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
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 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
LIS/Resources Forms
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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
LIS/Resources Forms
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.
Forms
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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
Forms
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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
LIS/Resources Forms
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
Forms
Lab Portfolio Lab Lead Form
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.
LIS/Resources Forms
Lab Portfolio Lab Lead Form
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
Forms
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
Strep
• 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
Strep
†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
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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
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ESR Blood Gas Coagluation Coagulation
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Lab Portfolio Siemens Hemostasis Solutions
Lab Lead Form HbA1c and Glucose
Lipid Profile
Medline POC Influenza A & B / RSV
Strep
Additional POC
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Specialty
ESR Blood Gas Coagulation Coagluation
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Lab Lead Form HbA1c and Glucose
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Lab Lead Form HbA1c and Glucose
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Additional POC
Urinalysis Hematology
Chemistry
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Specialty
ESR Blood Gas Coagluation Coagulation
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Lab Lead Form HbA1c and Glucose
Lipid Profile
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Strep
Additional POC
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Specialty
ESR Blood Gas Coagluation Coagulation
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Lab Lead Form HbA1c and Glucose
Lipid Profile
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Strep
Additional POC
Urinalysis Hematology
Chemistry
Immunoassay
Specialty
ESR Blood Gas Coagluation Coagulation
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Lab Lead Form HbA1c and Glucose
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Strep
Additional POC
Urinalysis Hematology
Chemistry
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Specialty
ESR Blood Gas Coagulation Coagluation
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Lab Lead Form HbA1c and Glucose
Lipid Profile
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Strep
Additional POC
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Chemistry
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Specialty
ESR Blood Gas Coagulation Coagluation
Cardiac LIS/Resources Forms
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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
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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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HbA1c and Glucose
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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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50
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7
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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
Forms
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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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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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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
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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
LIS/Resources Forms
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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
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COMPUGROUP MEDICAL’S Laboratory Division has the LIS solution for any facility performing laboratory testing
™
Urinalysis Hematology
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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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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ASSURITY LABS PLAN-A PHASES
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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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CGM LABDAQ
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SOLUTIONS
Chemistry
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COMPUGROUP MEDICAL’S Laboratory Division has the LIS
Blood Gas
solution for any facility performing laboratory testing
Coagulation
Cardiac ™
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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
Additional POC
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.
Hematology
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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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
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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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 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
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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