Wayne, Pennsylvania, USA—24 July 2007—Given the role of platelets in both hemorrhagic and thrombotic conditions and the rising significance of antiplatelet therapy in controlling platelet function across a broad spectrum of vascular disorders, establishing clear standardization to guide uniformity among laboratories performing platelet function testing is critical. Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) recently published a new document, Platelet Function Testing by Aggregometry; Proposed Guideline (H58-P), which provides concrete, standard procedures for using aggregometry to assess platelet function in patient specimens with the intent to achieve greater uniformity of results.
This guideline specifies requirements/recommendations for specimen collection, preexamination considerations, patient preparation, sample processing, testing, and quality control in relation to platelet function testing by aggregometry. It covers anticoagulants, specimen storage and transport temperatures, sample selection for various methodologies, establishment of reference intervals, result reporting, result analysis, assay validation, and troubleshooting. The goal of this guideline is to standardize platelet function testing when using light transmission aggregometry, whole blood impedance aggregometry, and shear-flow technologies.
The intended users of this guideline are clinicians, hospital and reference laboratorians, manufacturers, and regulatory agencies.
For additional information on CLSI or for further information regarding this release, visit our website at http://www.clsi.org
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.