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Cytometry B Clin Cytom. 2013 Sep-Oct;84(5):315-23. doi: 10.1002/cyto.b.21108.

Validation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS - part V - assay performance criteria.

Author information

1
University of Washington, Seattle, Washington, USA.

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.

KEYWORDS:

Cytometry; accuracy; imprecision; sensitivity; specificity

PMID:
24022854
DOI:
10.1002/cyto.b.21108
[Indexed for MEDLINE]
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