August 2014—The Clinical and Laboratory Standards Institute published H52-A2—Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition. This standard addresses the diagnostic red blood cell assays performed as fluorescence-based assays on a flow cytometry platform, including testing procedures for fetomaternal hemorrhage detection, paroxysmal nocturnal hematuria screening, membrane defect anemia testing for hereditary spherocytosis, and nucleated RBC counting. Caveats of interpretation and points of validation and quality control are also discussed.
CLSI published a new hematology document titled H60-A—Laboratory Testing for the Lupus Anticoagulant; Approved Guideline to assist in the standardization of lupus anticoagulant testing and address preexamination issues, examination concerns, and postexamination matters that pertain to interpretation of individual tests or combinations of assays. The document, which was written by experts in the field who reached a consensus on six criteria needed for making the laboratory diagnosis of lupus anticoagulant, offers practical information sourced from nearly 300 references and includes seven appendixes to visually aid the reader.
CLSI, 610-688-0100