Quality control and validation in flow cytometry

Abstract

Abstract Diagnostic flow cytometry has been established in laboratory diagnostics as an indispensable, deeply specialized method. Because of the special needs of the analysis in vital cells, the introduction and maintenance of quality management systems stays a challenge. Meanwhile, experience has been collected for quality controls and validation in diagnostic flow cytometry. This will be summarized in this article. The focus will be on the relevant rules and regulations for diagnostic laboratories and the associated requirements for medical diagnostics, as well the guidelines of the German Medical Association, Bundesärztekammer, (RiliBÄK) and in particular the accreditation according to DIN EN ISO 15189. In detail, factors influencing flow cytometry analyses, strategies for the standardization and harmonization in flow cytometry, and possibilities for verification and validation in the flow cytometry laboratory are given. A summary of the most frequent quality problems rounds up this overview.