CLSI H48 Determination of Coagulation Factor Activities Using the One-Stage Clotting Assay, 2nd Edition, H48Ed2E

This guideline provides recommendations regarding the proper collection and handling of specimens, reagents, controls, calibrators, and materials needed to optimize factor assay testing. It includes recommendations for good laboratory practices related to analyzer and reagent performance, reference intervals, lot-to-lot validation, and quality control. Assay limitations and sources of errors and variability are also included