How to Design and Validate a Clinical Flow Cytometry Assay.

Clin Lab Med

Department of Pathology, Duke University School of Medicine, Box 3712 DUMC, NC 27710, USA. Electronic address:

Published: September 2023

Multiparametric flow cytometry assays are long recognized as an essential diagnostic test for leukemias and lymphomas. Lacking Food and Drug Administration-approved standardized tests, these assays remain laboratory developed tests. The recently published guidelines, CLSI H62, are the most detailed and up-to-date instructions for designing and validating clinical flow cytometry assays. This review provides a historical background for the current situation, summarizes key points from the CLSI guidelines, and lists practical points for assay development gained from personal experience.

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http://dx.doi.org/10.1016/j.cll.2023.04.004DOI Listing

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