• Health Devices. 1997 Aug 1;26(8):296-332.

AbstractWhole blood Coagulation analyzers (WBCAs) are widely used point-of-care (POC) testing devices found primarily in cardiothoracic surgical suites and cardia catheterization laboratories. Most of these devices can perform a number of coagulation tests that provide information about a patient's blood clotting status. Clinicians use the results of the WBCA tests, which are available minutes after applying a blood sample, primarily to monitor the effectiveness of heparin therapy--an anticoagulation therapy used during cardiopulmonary bypass (CPB) surgery, angioplasty, hemodialysis, and other clinical procedures. In this study we evaluated five WBCAs from four suppliers. Our testing focused on the applications for which WBCAs are primarily used: Monitoring moderate to high heparin levels, as would be required, for example, during CPB are angioplasty. For this function, WCBAs are typically used to perform an activated clotting time (ACT) test or, as one supplier refers to its test, a heparin management test (HMT). All models included in this study offered an ACT test or an HMT. Monitoring low heparin levels, as would be required, for example,during hemodialysis. For this function, WBCAs would normally be used to perform either a low-range ACT (LACT) test or a whole blood activated partial thromboplastin time (WBAPTT) test. Most of the evaluated units could perform at least one of these tests; one unit did not offer either test and was therefore not rated for this application. We rated and ranked each evaluated model separately for each of these two applications. In addition, we provided a combined rating and ranking that considers the units' appropriateness for performing both application. We based our conclusions on a unit's performance and humans factor design, as determined by our testing, and on its five-year life-cycle cost, as determined by our net present value (NPV) analysis. While we rated all evaluated units acceptable for each appropriate category, we did identify some significant differences that enabled us to rank the units in order of preference. We have included a Selection, Purchasing, and use guide at the end of this study to help facilities identify the unit that will best meet their needs.

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