CLSI Publishes Protocol for the Evaluation, Validation, and Implementation of Coagulometers.WAYNE, Pa. -- Coagulometers are used in clinical laboratories for the common screening tests including prothrombin time, activated partial thromboplastin time Activated partial thromboplastin time Partial thromboplastin time test that uses activators to shorten the clotting time, making it more useful for heparin monitoring. , thrombin clotting time The Thrombin Clotting Time (TCT), also known as the Thrombin Time (TT), is a coagulation assay which is usually performed in order to detect for the therapeutic level of the anticoagulant Heparin. It is also sensitive in detecting the presence of a fibrinogen abnormality. , and Clauss fibrinogen Fibrinogen The major clot-forming substrate in the blood plasma of vertebrates. Though fibrinogen represents a small fraction of plasma proteins (normal human plasma has a fibrinogen content of 2–4 mg/ml of a total of 70 mg protein/ml), its conversion assay. In addition, most coagulometers also perform chromogenic chro·mo·gen·ic adj. Of or relating to a chromogen or to chromogenesis. chromogenic (krō´mōjen´ik), adj pertaining to color production. and immunoturbidometric assays. Some analyzers may also have the capability to perform chemiluminescent chem·i·lu·mi·nes·cence n. Emission of light as a result of a chemical reaction at environmental temperatures. chem assays. With newer trends in hemostasis testing and tailored reagent/instrument manufacturing, there is a need for a more holistic outlook to instrument evaluation prior to use for patient testing samples. In response to this need, Clinical and Laboratory Standards Institute (CLSI CLSI Clinical and Laboratory Standards Institute (Wayne, PA) CLSI Cisco Link Services Interface , formerly NCCLS NCCLS National Committee for Clinical Laboratory Standards ) recently published a new document, Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Proposed Guideline (H57-P), which specifies recommendations on how to plan and execute the selection, evaluation, validation, and implementation of a laboratory coagulometer. It includes assessment of safety, carryover, precision, bias, linearity, and comparability for coagulometers that perform clotting, chromogenic and/or immunoturbidometric and/or chemiluminescent testing. Finally, guidance is given on implementation, including training, education, and interfacing. The intended users of this guideline are hospitals, reference laboratories, and manufacturers. It is intended to be a guideline for evaluation of commercially available coagulometers that have received prior 510K clearance, CE mark, or other country-specific registration. For additional information on CLSI or for further information regarding this release, visit our website at http://www.clsi.org or call 610.688.0100. CLSI is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the healthcare and medical testing community. CLSI's unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system. |
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