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High-sensitivity Flow Cytometric Assays: Considerations for Design Control and Sensitivity Validation for Identification of Rare Events

Sommer, Ulrike and Eck, Steven and Marszalek , Laura and Stewart, Jennifer J. and Bradford, Jolene and McCloskey, Thomas W. and Green, Cherie and Vitaliti Garami, Alessandra and Oldaker, Teri and Litwin, Virginia (2020) High-sensitivity Flow Cytometric Assays: Considerations for Design Control and Sensitivity Validation for Identification of Rare Events. Cytometry Part B: Clinical Cytometry, Online (Online). ISSN 1552-49491552-4957

Abstract

The current consensus recommendation papers dealing with the unique requirements for the validation of assays performed by flow cytometry address the validation of assay sensitivity only in general terms (1-3). 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) as well as suggestions for reporting data near, or below, the LLOQ will be addressed. Thus, this paper will serve to provide best practices for the development, optimization, and validation of flow cytometric assays designed to assess rare events.

Item Type: Article
Keywords: flow cytometry validation, rare events, LLOQ, high-sensitivity assay, design control
Date Deposited: 02 Feb 2021 00:45
Last Modified: 02 Feb 2021 00:45
URI: https://oak.novartis.com/id/eprint/42541

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