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Press Release
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| Date:
2008-02-11 00:00:00 |
| Contact:
aholm@clsi.org |
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| Wayne, Pennsylvania, USA-February 2008-Coagulometers are used in clinical laboratories for the common screening tests including prothrombin time, activated partial thromboplastin time, thrombin clotting time, and Clauss fibrinogen assay. In addition, most coagulometers also perform chromogenic and immunoturbidometric assays. Some analyzers may also have the capability to perform chemiluminescent 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 testing patient samples. In response to this need, Clinical and Laboratory Standards Institute (CLSI) recently published a new document, Protocol for the Evaluation, Validation, and Implementation of Coagulometers; Approved Guideline (H57-A), 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, formerly NCCLS, is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the health care 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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For
further information please contact aholm@clsi.org or visit
www.clsi.org
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