Selliah Flow Validation Protocols

Guidance for Industry

This article discusses the validation suggestions for flow cytometry when determining precision, Limit of Blank (LOB), Limit of Detection (LOD), and Limit of Quantitation (LOQ) among other topics. This is a great resource in determining the needs to qualify a flow cytometry assay as well, and can potentially be applied to other assays if desired. This article discusses the statistical considerations as well as technical considerations when looking to validate a flow cytometry assay.

https://doi.org/10.1002/cpz1.868

 

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research

Published June 2015

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