{Reference Type}: Journal Article {Title}: Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part V - assay performance criteria. {Author}: Wood B;Jevremovic D;Béné MC;Yan M;Jacobs P;Litwin V; ; {Journal}: Cytometry B Clin Cytom {Volume}: 84 {Issue}: 5 {Year}: Sep-Oct 2013 {Factor}: 3.248 {DOI}: 10.1002/cyto.b.21108 {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.