title: Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part V - assay performance criteria.
abstract: Multi-color flow cytometry is a unique technology, which enables the analysis of heterogeneous cellular systems and provides multiparametric information on a cell-by-cell basis. A variety of factors contribute to the complexity of validating cell-based flow cytometric methods, including the lack of fully characterized cellular reference materials and the difficulty in obtaining, or creating, samples with varying levels of a given cell type or varying levels of expression of a given antigen. This document summarizes validation requirements and describes validation strategies for quasi-quantitative and qualitative cell-based flow cytometric assays.
authors.affiliation: University of Washington, Seattle, Washington, USA.
authors.forename: Brent
authors.initials: B
authors.lastname: Wood
authors.forename: Dragan
authors.initials: D
authors.lastname: Jevremovic
authors.forename: Marie C
authors.initials: MC
authors.lastname: Béné
authors.forename: Ming
authors.initials: M
authors.lastname: Yan
authors.forename: Patrick
authors.initials: P
authors.lastname: Jacobs
authors.forename: Virginia
authors.initials: V
authors.lastname: Litwin
mesh_terms: D019411:Clinical Laboratory Techniques / Q000379:methods*; D005434:Flow Cytometry / Q000379:methods* / Q000592:standards; D005456:Fluorescent Dyes; D006405:Hematology / Q000592:standards*; D006801:Humans; D016130:Immunophenotyping; D017410:Practice Guidelines as Topic; D012015:Reference Standards
chemical_list: D005456:Fluorescent Dyes
keywords: Cytometry; accuracy; imprecision; sensitivity; specificity