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Verification and validation of diagnostic laboratory tests in clinical virology.

Rabenau HF, Kessler HH, Kortenbusch M, Steinhorst A, Raggam RB, Berger A

Institute for Medical Virology, Johann Wolfgang Goethe University Frankfurt/Main, Germany. rabenau@em.uni-frankfurt.de

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.

Published 24 September 2007 in J Clin Virol, 40(2): 93-8.
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