scope:

This guideline specifies requirements/recommendations for specimen collection, preexamination considerations, patient preparation, sample processing, testing, result analysis, and quality control (QC) in relation to platelet function testing by aggregometry using light transmission aggregometry (LTA), whole blood impedance aggregometry as well as low and high shear technologies. 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 intended users of this guideline are clinicians, hospital and reference laboratorians, manufacturers, and regulatory agencies. This guideline is not intended for use with global hemostasis, platelet counting, flow cytometry, home testing, point-of-care, or research systems. This guideline does not address therapeutic guidance or interpretive guidelines.