Over the last two decades, flow cytometry has advanced from being primarily a research tool in the clinical laboratory to becoming the method of choice for immunophenotyping hematopoietic cells. In addition, the use of flow cytometry is crucial for the diagnosis of hematolymphoid neoplasia. Advances in the field, as well as lower costs for flow cytometers with greater data analysis capabilities, have contributed to the widespread use of flow cytometry in the clinical laboratory. With this increased utilization, laboratorians using flow cytometry need to implement quality assurance procedures to ensure that comparable results are obtained when using different commercially available instruments and reagents.

Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) has produced two new guidelines to support the clinical application of flow cytometry. Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline, 2nd ed (H42-A2) was developed to address issues of procedures and quality assurance for clinical applications of flow cytometry. 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 [1]. Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline, 2nd ed (H43-A2) is a document that builds on H42-A2 and provides guidelines for the appropriate performance of immunophenotyping for the proper diagnosis and management of patients with hematolymphoid neoplasia.

Read the full article text as published in the May 2007 issue of Clinical Cytometry.
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