INTERNATIONAL COUNCIL for STANDARDIZATION in HAEMATOLOGY
Validation of Cell-Based Fluorescence Assays: Practice Guidelines from the ICSH and ICCS
Part V – Assay Performance Criteria
Authors & Contributors
Brent Wood - Dragan Jevremovic - Marie C. Béné - Ming Yan - Patrick Jacobs - Virginia Litwin
10 September 2013
Written by the authors on behalf of ICSH/ICCS Working Group 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
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