CLSI H42

Enumeration of Immunologically Defined Cell Populations by Flow Cytometry, 2nd Edition

This document provides guidance for the immunophenotypic analysis of lymphocyte subsets and CD34+ (hematopoietic) stem cells by immunofluorescence-based flow cytometry; sample and instrument quality control; and precautions for acquisition of data from lymphocytes and CD34+ stem cells.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of June 2017. The document’s next scheduled review is generally five years after the reaffirmation date.

This document is available in electronic format only.

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Chairholder: Jan W. Gratama, MD, PhD

Date of Publication: May 22, 2007

Order Code PDF: CLSI H42A2E
ISBN Number: 1-56238-640-9

Order Code Print: print not available

Edition: Second

Pages: 88

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

CLSI H42 Abstract

Clinical and Laboratory Standards Institute document H42-A2—Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline—Second Edition was developed to address issues of procedures and quality assurance for clinical applications of flow cytometry. It is designed to aid clinical laboratorians in the development of quality assurance procedures and to establish the foundation for different laboratories using different commercially available instruments to obtain comparable results. Specific topics covered include: specimen collection, transport, and preparation; sample quality control and staining procedures; instrument calibration; sample analysis; and data analysis, storage, and reporting.