How POC testing is pushing the envelope I
t can be hard to remember a time when GPS was not available in cars, the Web didn’t exist, and only eight diagnostic tests were classified as waived and able to be performed at the point of care. But after CLIA’s enactment in 1988, those were some basic realities of location and speed.
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Today, whether for blood gas and electrolytes, glucose, coagulation, cardiac markers, drugs of abuse,
food pathogens, hemoglobin, or infectious diseases, hundreds of tests once considered too complex for point-of-care are routinely performed outside the laboratory. But some of the nation’s experts in point-of-care testing say that developments on the near horizon could make previous advances in POC testing look tame.
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drugs of abuse testing
PAG E 2
BluRapids™ Multi-Drug Test Cup
Multi-Panel Drug Test Cup
25 tests/box
item# TNR DOA12 A ( 12-Panel) AMP/BAR/BUP/BZO/COC/MDMA/ MET/MOP/MTD/OXY/PCP/THC
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item# TNR DOA13A ( 13-Panel) AMP/BAR/BUP/BZO/COC/MDMA/ MET/MOP/MTD/OXY/PCP/TCA/THC
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Multi-Drug Dip Card Tests
Oral Fluid Collection
25 tests/box
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Alcohol Screen Saliva Tests
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Lab Consumables
PAG E 3
Lab Coats
Nitrile Gloves
Vinyl Gloves
item# TNR 2410 • 10/pack
item# TNR 700 • 100/box
item# TNR 400 • 100/box
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Biohazard Bags
Specimen Cups
item# TNR 69BIOBG • 1000/case
item# TNR HXK 261 Non-Sterile, 3oz 400/case
• Dimensions: 6” x 9” • 3-Wall Biohazard Specimen Bags with Flap and Tear-Line (Weak-Line)
item# TNR HXK 262 Sterile, 3oz 400/case
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item# TNR HXK352 Sterile, 4oz 300/case
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Tamper Evident Seals item # SHA STR51
• Used for Chain of Custody Procedures in Drug Testing to Detect Tampering with Specimen Containers or Vials • Contains Space for Donor ID (THY 39554, THY 40008) • “Do Not Use If Protective Seal is Broken.” (SHA STR51)
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rapid tests Tanner Scientific® iFOB
PAG E 4
Strep A & Flu Test Kits
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Tanner Scientific® hCG
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item# QUI 20183 • 25 tests/kit
item# GEN 190 • 25 tests/kit
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• Immunochromatographic Assay Detects Influenza A and Influenza B Viral Nucleoprotein Antigens
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item# TNR HCGCOMBO • 50 tests/box • PREGNANCY URINE/SERUM COMBO TEST • Easy-to-Use One-Step Test, Increased Time for Patient Care
BD® Veritor™ System
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Dispette2®
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100/box
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item# TNR 0003 (5mL)
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LifeSign® Uricult® Bacterial UTI Tests item# LIX 1000 (CLED/EMB)
10/box
item# LIX 1001 (CLED/MacConkey) item# BEC 256045 • 30 test kits/pack • Rapid Chromatographic Immunoassay Used for the Direct and Qualitative Detection of Influenza A and B Viral Nucleoprotein Antigens from Nasal Swabs
item# LIX 1002 (CLED/Polymyxin/EMB) item# LIX 1003 (CLED/Polymyxin/MacConkey) • Easy-to-Perform Bacterial Culture Method for the Diagnosis of Urinary Tract Infections
Serology
PAG E 5
Serology Test Kits RPR SYPHILIS
ASO
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item# ASI 300X
25/ 100/500 tests
25/50/ 100/ 1,000 tests
5,000 ( 10 Well) tests 10,000 (30 Well) tests
CRP
RUBELL A
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item# ASI 600X
25/50/ 100/ 1,000 tests
30/ 100/500 tests
RF DIREC T
SICKLE CELL
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25/ 100/ 1,000 tests
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25/50/ 100/ 1,000 tests
25/50/ 100/ 1,000 tests
RPR/VDRL CONTROL SET
glucose testing Vital® Glucose Meter item# ARK 760001 • TEST TIME: 7 SECONDS • Sample Size: 0.5 uL • Meter Range: 20-600 mg/dL • Results: Plasma Referenced • Calibration: Auto Coding
TE ST STRIPS
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item# ASI 9050025 • 3 x 2 . 5mL
PAG E 6
Continued from Cover
“A number of tests are on the cusp of being available at point of care, from the realm of infectious disease biomarkers, all the way up to PCR and molecular testing right at the bedside,” says Timothy R. Hamill, MD, vice chair of the CAP Point-ofCare Testing Committee. Wearable biosensors and lab tests on a chip are no longer just the stuff of science fiction, says Dr. Hamill, who is director of clinical laboratories at the University of California, San Francisco. “It’s amazing technology and it’s going to bring a real revolution.”
“Other things like rapid tests for viral pathogens and/or diagnosing ventilator-associated pneumonia may be viewed as more important to clinicians than screening for MRSA carriers. Similarly, in the case of a patient with possible sepsis, being able to do a quick test to find out if it looks like grampositive or gram-negative bacteria would let clinicians start an empiric therapy right away while they’re waiting for a test to be done in the lab on a MALDI-TOF or one of the other newer bacterial identification systems.”
“Ten years ago, people would have said, yeah, maybe when we’re flying around in spaceships that’ll happen. But it’s here. And where it will go will be really interesting to see.”
More POC testing that helps reduce antimicrobial resistance would be a boon, Dr. Hamill believes. With the right POC device, “You could test at the bedside, find out the nature of the causative bacteria, and perhaps learn something about its susceptibility patterns based on the test result. Then you would know how to structure your antibiotic therapy right from the get-go, and not expose it to that heavyweight drug that we really need to reserve for that organism that’s really resistant.” Such a device isn’t available at the point of care yet, but with MALDI-TOF mass spectrometry in the central laboratory, answers that used to take 24 to 36 hours can now get out in a few hours, helping hospitals with antibiotic stewardship.
It’s not only technology that’s pushing POC testing in new directions. Research findings, new regulatory scrutiny, and economic and business imperatives are powering point-ofcare testing to carve out a new niche within the health care system. In conversations with CAP TODAY, pathologists and others all agree that it will continue to diversify and mushroom. From differing perspectives, they report on how government and industry initiatives are combining with research and clinical practice to steer POC testing into its next era.
“We’ve got competing pressure Molecular testing at the point of points on POC testing,” Dr. care is promising, Dr. Hamill Hamill says. “One is a desire to says, but it will take some time. get a quick, reliable answer “I think when the FDA approves immediately so a provider can molecular tests at point of care, make a treatment decision on a they will initially be either patient. Second, that laboratory moderate or high complexity, test is probably more expensive and at least from the institutions than what we can do in the I’ve reviewed as a CAP inspector, clinical lab. Everyone’s looking no one is going to do high- DR. TIMOTHY HAMILL at cost containment these days, complexity tests at point of care. so the cost of testing in the For example, here in California, inpatient arena is being scrutinized. In the outpatient setting, because of our regulations regarding who can perform highthe question is: Can we get reimbursed for a POC test? Is a complexity testing, if I tried to roll out a POC test that only lack of reimbursement sufficient to say we shouldn’t use it?” licensed clinical laboratory scientists or physicians could perform, it would be very hard. Certainly in inpatient care “Third, there is the ever increasing level of regulatory scrutiny and probably the physician office, it’s eventually going to on POC testing, particularly when it comes to providerhappen, but I don’t know when.” performed tests. It used to be the doctor could run any kind of test. Now pretty much everything has regulations wrapped Also likely in time, he says: Glucose, sodium, serum chemistry, around it—competency evaluations are an example. I think it and chloride testing will be done by biosensor or new POC is appropriate, but all of this weighs against the potential technology, and samples for such testing will no longer be benefits of having rapid POC testing at the bedside.” sent to the clinical lab. That means the laboratory will be moving on to testing more esoteric biomolecules, hormones, Quick answers on possible infectious diseases are a chronic drugs, and other analytes that still aren’t available as a POCneed, but there are always tradeoffs to take into account. For type test, Dr. Hamill predicts. “With point-of-care testing, I instance, a POC test for methicillin-resistant Staphylococcus think we’ll be amazed by what happens in five years. And aureus is in the regulatory pipeline and will be a significant we’ll be stupefied at what we’ll be able to do in 10 years.” step forward in identifying infections with these organisms, Copyright College of American Pathologists. Used with permission. but Dr. Hamill does not believe it would change the way patients are screened for MRSA carriage. “Although potentially quicker, the cost will likely be an issue,” he says, and the MRSA culture his hospital can do in the clinical lab probably has a fast enough turnaround already.
“With point-of-care testing, I think we’ll be amazed by what happens in five years. And we’ll be stupefied at what we’ll be able to do in 10 years.”
In the outpatient setting, the question is: “Can we get reimbursed for a POC test? Is a lack of reimbursement sufficient to say we shouldn’t use it?” - DR. TIMOTHY HAMILL
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Continued from Page 6
S
urprisingly, there has been almost no research on the question of patient satisfaction with POC testing. Do patients find POC testing as convenient as their clinicians do? That is one of the questions that interests Kent B. Lewandrowski, MD, associate chief of pathology and director of laboratory and molecular medicine at Massachusetts General Hospital, who undertook a twofold study of POC testing in a physician practice to find out. The study involved implementing POC testing for HbA1c, a lipid panel, and a comprehensive metabolic panel in a primary care practice. “We wanted to determine the impact on patient satisfaction and also on practice efficiency,” says Dr. Lewandrowski, who is a professor of pathology at Harvard Medical School. “We chose those tests because they are the most commonly ordered ones, and we gave the patients an anonymous questionnaire inquiring about their satisfaction on a scale of bad/horrible to lovely/wonderful.”
complete blood counts and they come in a convenient POC format, we might add those.” That’s not such a far-fetched idea, Dr. Lewandrowski notes, because waivers have been the trend. “Probably one sentinel event was a year or two ago when the Food and Drug Administration approved an over-the-counter salivary HIV test that is also CLIA waived for use in practices. The saliva tests are being used in settings where HIV is commonly encountered, such as EDs, STD clinics, ID clinics, and so on. So you’d have to say, if the FDA is okay with that, they’re probably going to be okay with a lot more. Because other tests are not as controversial as HIV.”
There are many companies working on molecular POC testing, and Dr. Lewandrowski predicts that molecular diagnostics for microbiological applications will be the first to take off. “It’s an ideal test for point of care because traditional methods take so long. And it will take off in hospital settings for MRSA and C. difficile where we need rapid identification of infected patients, and also in clinics where they need viral load monitoring of patients with HIV or HCV to make decisions concerning treatment.” - DR. KENT B. LEWANDROWSKI
“We wanted to determine the impact on patient satisfaction and also on practice efficiency.”
“Suffice it to say that the scores were extremely high: ‘It was great to review results with my doctor at the time of the office visit,’ ‘It’s very convenient,’ ‘It makes the whole experience much more enjoyable and positive.’ The study also found that the number of letters and phone calls as well as the total number of tests ordered and the number of re-visits fell. So there was strong improvement in practice outcomes,” Dr. Lewandrowski says. For the next phase of the study, the researchers will test the same model with different practices to see whether they can generalize their findings. “This has not been extensively studied in the past.” In fact, he says, “There are essentially no studies of efficiency outcomes in primary care.” He hopes to expand this inquiry to include other panels as they become available at point of care. “At some point, when there are CLIA-waived
Another advantage of fast molecular microbiology is managing beds, he says. “If it takes 24 hours for the lab to turn the test result around, you’re having to manage your beds based on a lack of knowledge. You can’t put an influenza patient in with a patient who doesn’t have flu, so it makes it very difficult.” He sees a strong trend toward increased POC testing across the board. “We are getting more and more requests for it, and a lot of that is being driven by the need for the hospital to improve its capacity utilization and efficiency, which can be problematic as we’re getting pushed to get more patients through the system.” Copyright College of American Pathologists. Used with permission.
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urinalysis
PAG E 8
Clarity® Urocheck 120 • UP TO 120 TESTS PER HOUR!
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hba1c
PAG E 9
A1cNow+® Analyzer item# PTS 3024 ( 10/box) • PTS 3021 (20/box) • RESULTS IN 5 MINUTES!
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hemoglobin (Hb) MissionPlus® Monitoring System item# MHB C 112 3051
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1) Lancing Patient Finger
2) Producing Bead of Blood
3) Collecting Sample #1
4) Collecting Sample #2
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Coaguchek® XS Test Strips item# ROC 046253 15160 • 4 8 strips/box • RESULTS IN LESS THAN 1 MINUTE! • For Determination of Prothrombin Time Tests for Coagulation Levels • Strips are Stored in Vials (Small Plastic Bottles), Each Containing Its Own Specific Code Chip • Whenever Possible, Strips Should Remain in Vial with Cap Closed to Protect from Humidity and Contamination • Store at Room Temperature and Out of Direct Sunlight • Uses Only a Small Drop (8uL) of Capillary Blood
chemistry
PAG E 11
Medica EasyRA® item# NAN 10405
Clinical Chemistry Analyzer for Medical Laboratories WORKLIST • Real-Time Display of Sample Status • Up to 7 Configurable Test Panels • Automatic Inventory of Reagents and Cuvettes Prior to Run • Pause Feature for “On the Fly” Editing • Automatic Search of Pending Samples • Convenient Re-Run of Tests that Require Diluting • LIS Connectivity RE SULTS • ANALYZE STAT SAMPLES WITH RESULTS IN LESS THAN 8 MINUTES! • Touch Sample Position on Display for Detailed Patient Results • Easy Access to Current and Past Results in Multiple Print and Viewing Formats • On-Board Patient Result Search and Sorting Capability • Levey Jennings QC Charts STATUS • On-Screen Display of Tables and Graphics Gives Status of Reagents, Cals and QC • Detailed Automatic Warnings
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Refurbished Chemistry Analyzers Olympus® AU400 Ideal as a primary chemistry analyzer for small to medium size hospitals and laboratories, or as a dedicated specialty analyzer for larger institutions. Automate and consolidate chemistry testing with Olympus' 125 test menu including chemistry, urine chemistry, specific proteins, esoteric chemistries and tests for therapeutic drug monitoring, drugs-of-abuse, and thyroid function. With random access throughput of up to 400 photometric tests per hour (up to 800 with electrolytes), on-board menu of over 40 tests and user-definable sample handling options, the Olympus® AU400 delivers efficiency for real world lab needs.
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immunoassay
PAG E 12
FREND™ System Get Lab Quality Results Without Giving Up Profits!
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• Fully Automated System Provides Accurate Lab Quality Test Results • Quantitative Immunoassay Analyzing Device Utilizes Disposable Kits to Provide In Vitro Measurement Results for TSH, PSA, etc • Equipped with Easily Maneuverable Touch Screen User Interface • Compact, Portable, Requires Only a Small Sample Volume item# NAN F 10 • NanoEnTek ® FREND System item# NAN FRPS025 • PSA Plus Reagent • 25 tests/box item# NAN FRTH025 • TSH Reagent • 25 tests/box
Refurbished Immunoassay Systems Beckman® Access 2 • Users View Rack and Run Completion Time in Real Time Onscreen, the Information on Requested Tests, Any Pending Work and Results, and the Status of Required Supplies • Touch-Panel User Interface; User-Defined Reflex Testing • On-Board Refrigeration which Enhances Reagent Stability • Incorporates Magnetic Particle Separation with Chemiluminescent Detection Technology for Rapid Assay Processing and Wide Analytical Range • Unique Network and Sample Handling Technologies, Allows Users to Link Up to Four Systems through One LIS Interface, Enabling Information-Sharing • Continuous Random Access and STAT Capability
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