High‐sensitivity flow cytometric assays: Considerations for design control and analytical validation for identification of Rare events. Issue 1 (17th September 2020)

• Record Type: Journal Article
• Authors: Sommer, Ulrike; Eck, Steven; Marszalek, Laura; Stewart, Jennifer J.; Bradford, Jolene; McCloskey, Thomas W.; Green, Cherie; Vitaliti, Alessandra; Oldaker, Teri; Litwin, Virginia
• Is Part Of: Cytometry. Volume 100:Issue 1(2021)
• Page Start: 42
• Page End: 51
• Publication Date: 2020-09-17
• Subjects: design control -- flow cytometry validation -- high‐sensitivity flow cytometric assay -- LLOQ -- rare events; Flow cytometry -- Diagnostic use -- Periodicals; Cytodiagnosis -- Periodicals; 616.07582
• DOI: 10.1002/cyto.b.21949
• Languages: English
• ISSNs: 1552-4949

Abstract

Abstract: The current consensus recommendation papers dealing with the unique requirements for the analytical validation of assays performed by flow cytometry address the validation of sensitivity (both analytical and functional) only in general terms. In this paper, a detailed approach for designing and validating the sensitivity of rare event methods is described. The impact of panel design and optimization on the lower limit of quantification (LLOQ) and suggestions for reporting data near, or below, the LLOQ are addressed. This paper serves to provide best practices for the development, optimization, and analytical validation of flow cytometric assays designed to assess rare events. Note that this paper does not discuss clinical sensitivity validation, which addresses the positive and negative predictive value of the test result.