Premium
High‐sensitivity flow cytometric assays: Considerations for design control and analytical validation for identification of Rare events
Author(s) -
Sommer Ulrike,
Eck Steven,
Marszalek Laura,
Stewart Jennifer J.,
Bradford Jolene,
McCloskey Thomas W.,
Green Cherie,
Vitaliti Alessandra,
Oldaker Teri,
Litwin Virginia
Publication year - 2021
Publication title -
cytometry part b: clinical cytometry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.646
H-Index - 61
eISSN - 1552-4957
pISSN - 1552-4949
DOI - 10.1002/cyto.b.21949
Subject(s) - sensitivity (control systems) , computer science , identification (biology) , limit (mathematics) , data mining , flow (mathematics) , event (particle physics) , rare events , reliability engineering , engineering , statistics , mathematics , physics , biology , mathematical analysis , botany , geometry , electronic engineering , quantum mechanics
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.