POCT supplements clinical lab services

Oct. 1, 2003
Intended to supplement rather than replace central laboratory services, point-of-care testing (POCT) refers to the analytical near-patient testing provided within a healthcare institution, but performed outside the physical facility of a clinical laboratory. Apart from providing immediate results, POCT does not require permanent dedicated space, as kits and analytical instruments are temporarily transported to the patients bedside or care location (e.g., operating room, intensive care unit), with the ultimate objective of delivering quick and accurate information to facilitate the timely diagnosis and treatment of patients.Complete lipid profile

CLIA-waived, the LDX System offers efficient and economic diagnostic testing for cholesterol and related lipids, blood glucose/glycermic control and liver function at the point of care. Using a fast three-step procedure and a single fingerstick drop of blood, a complete lipid profile, plus glucose and ALT, can be measured by the system in five minutes. Factory calibrated, with easy and inexpensive software upgrades, the LDX System has a small portable footprint for easy tabletop usage/storage and includes a printer providing patient test results in duplicate.LDX
Analyzer

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Handheld chemical analyzer

The new palm-sized, CLIA-waived PocketChem UA is an automated POC urinalysis analyzer that tests for GLU, KET, BIL, URO, pH, PRO, BLD, LEU, SG and NT. Designed for use with ARKRAY Aution Sticks 10TA for urinalysis, the system standardizes urine test strip results by removing variable lighting-condition impact on test performance, eliminating different peoples skill at matching colors, errors in prescribed testing times, and reducing transcription and clerical errors. Each strip includes a calibration pad that automatically corrects for interference from the natural color of urine, optimizing the accuracy of results. The PocketChem UA also features built-in thermosensor to compensate for the influence of ambient temperature on test results, simple patient identification entry, throughput of 60 samples per hour and memory capacity of 100 most recent test results downloadable to a PC, which eliminates transcription errors with easy-to-read printouts.PocketChem
UA
www.rsleads.com/311ml-169Benchtop critical-care analysis
The GEM Premier 3000 is a blood gas, electrolyte, glucose, lactate and hematocrit analyzer. The systems analytical performance is based on state-of-the-art planar sensors, providing simplicity that streamlines every aspect of blood gas testing. The easy-to-use, cartridge-based technology only requiring replacement every three weeks incorporates sensors, solutions, gases, pump tubing waste container and sampler, all the materials needed for testing. Recently enhanced, the GEM cartridge system now offers Intelligent Quality Management, an internal, report-generating, automated system that performs continuous quality management and replaces the use of traditional quality control.GEM
Premier 3000 Analyzer

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Cardio multimarker panel
The Triage Cardio ProfilER combines four markers of cardiovascular disease in one test panel, providing rapid, simultaneous, quantitative measurement of creatinine kinase, myoglobin, all forms of troponin 1 and b-type natriuretic peptide within 15 minutes. The test is performed by placing a few drops of whole blood onto a small diagnostic chip, which is inserted into the portable Triage MeterPlus testing platform. The meter scans the chip using fluorescence technology to measure the level of a targeted marker in a patients sample. Providing quick and accurate results, the Triage MeterPlus incorporates extensive quality control features, lot-specific calibration technology, data storage capacity of 750 patient results and interfacing capabilities, enabling transfer of information from remote locations to laboratory and hospital information systems.Triage
Meterplus/Cardio Profiler

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Plug-and-play connectivity

An innovative stat analyzer offers seven test menus, including as few as three tests to as many as 19 measured and 29 calculated tests. The Stat Profile Critical Care Xpress can measure blood gases, electrolytes, chemistry and hematology with onboard co-oximetry in a single, all-in-one, compact instrument. Designed to maximize the number of tests while minimizing labor requirements, the system features snap-in reagent packs containing all required liquid and gas calibrators, and onboard controls, as well as a sealed container that stores sample and reagent waste. Compliant with NCCLS/IFCC plug-and-play connectivity standards, the Critical Care Xpress can utilize Remote Testing Management software to provide process automation, remote control, remote review and data capture for efficient operation.Stat
Profile Critical Care Express

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Photometric technology

The SureStepFlexx Professional Blood Glucose Monitoring System, together with SureStepPro Test Strips, brings photometric technology to the point of care, delivering accurate and precise results in three easy-to-use steps. Safe and convenient, the absorbent test strips provide off-meter dosing, especially suited to ICU, neonatal and isolation units, minimizing the risk of infection for patients and staff. The system is supplied with pre-set commonly preferred default settings, but provides the flexibility of customizing meter configurations. Added features include a menu-driven touch screen, customizable security lockouts, optional barcode scanner, lockouts and warnings ensuring QC and regulatory compliance, as well as automatic downloading to a data management system.SureStepPro
System

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In vitro diagnostics
A broad line of POC products, under the Instant-View brand, aid in the detection of drugs of abuse, fertility and cancer markers. A new addition is the Instant-View Fecal Occult Blood II Test, a rapid lateral flow immunoassay designed to detect human hemoglobin in stool as an indicator of possible colorectal cancer. The immunochemical nature of the test eliminates the need for dietary restrictions, thereby increasing accuracy and patient compliance over traditional guaiac-based test. The test kit includes a convenient specimen-collection tube that allows the stool sample to remain hydrated and doubles as a sample applicator. This CLIA-waived test is available in cassette or dip strip format and gives a clear visual result in five to 10 minutes upon addition of sample.Instant
View FOB II Test

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Rapid immunological test
The Link2 H. Pylori Rapid Test is a CLIA-waived, dry-chemistry, immunological rapid test for the detection of antibodies to Helicobacter pylori, the causative agent of Type B chronic gastritis. Designed to give a positive result in patients who are or have been infected with H. pylori, the POCT is an easy-to-perform three-step process, requiring no specialized equipment or instrumentation. The test device incorporates a strip of plastic-backed membrane held in a result window that displays two lines: a test line containing H. pylori antigen and a control capture line. Visible and easy to interpret, positive results are available in one minute and negative results in five.Link2
H. Pylari Rapid Test Kit

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Qualitative DOA results

For the qualitative detection of DOA in human urine, the OnTrak TesTcard9 panel is a simple yet rapid diagnostic device for the qualitative detection of nine illicit drugs: cocaine, THC (marijuana), barbiturates, benzodiazepines, phencyclidine, methamphetamine, tricyclic antidepressants, morphine and amphetamines. The testing procedure requires no mixing, timing or special training and offers the choice of sample application methods. The sample end of the card can either be dipped into the urine specimen or the urine can be pipetted into the individual sample wells. Easy-to-read results are available in three to five minnutes with a blue band indicating a negative result and the absence of blue signifying a preliminary positive result.OnTrak
TesTcard 9
www.rsleads.com/311ml-176Layered Thin Film technology

Layered Thin Film technology has been incorporated into a new rapid POCT platform that is easy to read, quick, extremely precise and is as small and thin as a credit card. The first two tests available are in the infectious vaginitis category: QuickVue Advance pH and Amines test (intended for the clinical evaluation of infectious vaginitis) and QuickVue Advance G. vaginalis test (intended for the detection of Gardnerella vaginalis). Both tests require no reagents and are ready to use without preparation, have a simple three-step procedure and can be stored at room temperature for up to 24 months.QuickVue
Advance

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Clarification
In the October 2003 issue of MLO, page 44, Innovations in blood collection the Myco Medical product photo should have been the Vaku-8 Plus, rather than the Unolok Plus infusion set as was pictured. In addition, the product description indicated that the Vaku-8 blood-collection set incorporates an OSHA-compliant shielded needle, which is not the case. We regret any confusion to our readers. 
                                                                             
November 2003: Vol. 35, No. 11
© 2003 Nelson Publishing, Inc. All rights reserved.