CLSI releases new hematology standards on RBC diagnostic and lupus anticoagulant testing

May 2, 2014

The Clinical and Laboratory Standards Institute (CLSI) has published an updated version of H52-A2—Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition. This standard addresses the diagnostic red blood cell (RBC) 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. Points of validation and quality control and caveats of interpretation are also discussed.

This revised edition includes preferred testing methodology for diagnosis of paroxysmal nocturnal hemoglobinuria and nonimmune membrane-associated hemolytic anemias. H52-A2 examines diagnostic tools to further evaluate anemic conditions by the reliable quantitation of adult F-cells and nucleated RBCs. It discusses points of validation and quality control, and caveats of interpretation.

CLSI also published a new hematology document, H60-A—Laboratory Testing for the Lupus Anticoagulant; Approved Guideline. This standard provides guidance and recommendations regarding the proper collection and handling of the specimen; descriptions and limitations of screening and confirmatory assays, and mixing tests used to identify lupus anticoagulant (LA); determination of cutoff values and calculations associated with the various assays; and interpretation of test results in an LA panel.

This new standard assists in the standardization of LA testing and addresses pre-examination issues, examination concerns, and post-examination matters that pertain to interpretation of individual tests or combinations of assays. It was written by experts in the field who reached a consensus on six criteria needed for making the laboratory diagnosis of LA. The document guides the reader on how the criteria can be met by offering practical information sourced from nearly 300 references. H60-A also includes seven appendixes to help visually aid the reader. Read sample pages.

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