How to Design and Validate a Clinical Flow Cytometry Assay.

Authors :: Lagoo AS
Source :: Clinics in laboratory medicine [Clin Lab Med] 2023 Sep; Vol. 43 (3), pp. 333-349. Date of Electronic Publication: 2023 May 29.
Publication Year :: 2023
Abstract: 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.<br />Competing Interests: Disclosure The authors have nothing to disclose.<br /> (Copyright © 2023 Elsevier Inc. All rights reserved.)