Validation of cell‐based fluorescence assays: Practice guidelines from the ICSH and ICCS – part V – assay performance criteria

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. © 2013 International Clinical Cytometry Society