Call for Nominations
Platelet Function Testing; Protocol for the Evaluation of Coagulometers (Coagulation Analyzers)

Platelet Function Testing

With the availability of anticoagulated blood, many techniques to measure platelet function have been developed including platelet aggregometry, release of granular contents, measurement of changes in membrane surface markers, and platelet survival. However, there is no clear standardization of which anticoagulant is best for platelet function testing, and, depending on the anticoagulant used, different test results may be obtained. This guideline is intended to be a first step toward the development of standardization of platelet function testing that will ultimately lead to improved accuracy of diagnosing those conditions where platelet hypo- and hyperactivity need to be assessed and treated. This guideline will address the following:

• sample collection, preparation, storage, and transport
• sample testing
• quality control
• reference methods for measuring platelet function
• validation of new assays or technologies

Requested Experience: Members should have a background in Hematology (clinician or scientist) and a definite knowledge of platelet biology and function. IVD manufacturers with experience in anticoagulants as well as manufacturers and end-users with experience in platelet function testing systems.

Protocol for the Evaluation of Coagulometers (Coagulation Analyzers)

Coagulometers used in clinical laboratories have become increasingly complex and the evaluation of such instruments is complicated and time consuming. Existing evaluation guidelines are generally aimed at clinical chemistry analyzers, in which well-defined analytes, with well-documented reference materials/standards are assayed and a range of suitable matrices are available. This document will describe the various levels of evaluation (i.e., preliminary, performance, and efficiency) and give guidance on how to plan and execute the evaluation of a laboratory coagulometer. This guideline will also provide methods on how to evaluate a mainline coagulometer with respect to screening tests, factor assays, chromogenic assays, and immunoturbidometric assays before introduction into a routine laboratory. It will cover the assessment of safety, carryover, precision, bias, linearity, and comparability.

Requested Experience: The committee should include clinicians, technologists, and IVD manufacturers with a background in performance evaluation of coagulometers.

Please review the volunteer experience parameters and the proposed project objective, and submit a nomination.

The deadline to submit the nomination form including a curriculum vitae and disclosure of interests form, to CLSI Offices, 940 West Valley Road, Suite 1400, Wayne, PA 19087 is 5 June 2005.

To provide input on the need for, and utility of, this proposed new project, give us your opinion on the value of the project.

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