This guideline includes validation strategies for cell-based assays performed by flow cytometry. This guideline also includes recommendations for instrument qualification and standardization and assay optimization. It also covers recommended practices for the examination and postexamination phases.
Hematology | Standards
CLSI’s Hematology standards provide guidance and recommendations for the proper collection, handling, storage, and testing of hematological specimens. These standards include recommendations for good laboratory practices related to analyzer and reagent performance, as well as information on QA and QC in the hematology laboratory.
H48 | Determination of Coagulation Factor Activities Using the One-Stage Clotting Assay, 2nd Edition
This guideline gives recommendations for the collection and handling of specimens, reagents, controls, calibrators, and materials to optimize factor assay testing.
This guideline addresses the diagnostic red blood cell (RBC) assays performed as fluorescence-based assays on a flow cytometry platform.