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Review
. 2007 Oct;40(2):93-8.
doi: 10.1016/j.jcv.2007.07.009. Epub 2007 Sep 4.

Verification and validation of diagnostic laboratory tests in clinical virology

Holger F Rabenau  1 , Harald H Kessler, Marhild Kortenbusch, Andreas Steinhorst, Reinhard B Raggam, Annemarie Berger
Affiliations
Review

Verification and validation of diagnostic laboratory tests in clinical virology

Holger F Rabenau et al. J Clin Virol. 2007 Oct.

Abstract

This review summarizes major issues of verification and validation procedures and describes minimum requirements for verification and validation of diagnostic assays in clinical virology including instructions for CE/IVD-labeled as well as for self-developed ("home-brewed") tests or test systems. It covers techniques useful for detection of virus specific antibodies, for detection of viral antigens, for detection of viral nucleic acids, and for isolation of viruses on cell cultures in the routine virology laboratory.

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