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.