CLSI H52

Red Blood Cell Diagnostic Testing Using Flow Cytometry, 2nd Edition

This guideline 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 document is available in electronic format only.

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Chairholder: Bruce H. Davis, MD, FCAP

Date of Publication: March 28, 2014

Order Code PDF: CLSI H52A2E
ISBN Number: 1-56238-958-0

Order Code Print: print not available

Edition: Second

Pages: 114

CLSI H52 Additional Details

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This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of January 2021. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI H52 Abstract

Clinical and Laboratory Standards Institute document H52-A2—Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition addresses the diagnostic RBC assays performed as fluorescence-based assays on a flow cytometry platform. Preferred and alternative testing procedures for fetomaternal hemorrhage detection, paroxysmal nocturnal hematuria screening, membrane defect anemia testing for hereditary spherocytosis, and nucleated RBC counting are reviewed. Preferred testing methods, points of validation and QC, and caveats of interpretation are discussed from the perspectives of laboratory practitioners, diagnostic test developers, and regulators. Where appropriate, this guideline integrates current statements of other relevant organizations, such as the International Council for Standardization in Haematology.