CLSI Establishes Performance Guidelines for Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells

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. The newly published edition of Clinical and Laboratory Standards Institute’s (CLSI, formerly NCCLS) document, Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline–Second Edition (H43-A2), 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.

H43-A2 is designed to help clinical laboratories using different commercially available instruments and reagents obtain comparable results, and to aid these laboratories in the development of quality assurance procedures that are specifically applicable to such cases.

This document, which builds on CLSI document Enumeration of Immunologically Defined Cell Populations by Flow Cytometry (H42), covers issues specific to the study of samples of acute and chronic leukemias, non-Hodgkin’s lymphomas, plasma cell neoplasms, and myelodysplastic syndromes.

This document is a revision of H43-A, published in 1998. Since the publication of H43-A, there has been a substantial expansion of the application of flow cytometry in hematolymphoid neoplasia. This document has been revised to reflect the advances, such as:

improved instrumentation;

expansion of the routine use of four or more color flow cytometry;

development of new applications in assessment of hematolymphoid malignancies;

increased importance of clinical flow cytometry in analysis of hematolymphoid neoplasia;

clinical utility of flow cytometric analysis in new disease categories;

description of prognostic immunophenotypic markers; and

the role of flow cytometric immunophenotyping in evaluation of patients for monoclonal targeted therapies.

For additional information on CLSI or for further information regarding this release, visit our website at http://www.clsi.org or call +610.688.0100.

CLSI is a global, nonprofit, membership-based organization dedicated to developing standards and guidelines for the healthcare and medical testing community. CLSI’s unique consensus process facilitates the creation of standards and guidelines that are reliable, practical, and achievable for an effective quality system.