CLSI H43

Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells, 2nd Edition

This document provides performance guidelines for the immunophenotypic analysis of neoplastic hematolymphoid cells using immunofluorescence-based flow cytometry; for sample and instrument quality control; and precautions for acquisition of data from neoplastic hematolymphoid 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: Maryalice Stetler-Stevenson, MD, PhD

Date of Publication: April 23, 2007

Order Code PDF: CLSI H43A2E
ISBN Number: 1-56238-635-2

Order Code Print: print not available

Edition: Second

Pages: 96

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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 H43 Abstract

The importance of immunophenotyping for the proper diagnosis and management of patients with hematolymphoid neoplasia necessitates the development of guidelines for the appropriate performance of these techniques in the clinical laboratory. CLSI document H43-A2—Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline—Second Edition addresses issues of safety, specimen collection and transportation, sample preparation, immunofluorescent staining, instrument quality control, data acquisition, and data storage for the application of flow cytometry to the immunophenotypic analysis of these disorders. This document builds on CLSI document H42—Enumeration of Immunologically Defined Cell Populations by Flow Cytometry.