Article
European multi-centre validation study of NucliSens Extractor in combination with HCV Amplicor 2.0 assay for HCV-NAT screening of plasma pools.
Biologicals : journal of the International Association of Biological Standardization - 1 Dec 1999
Cuypers H T, van Dijk R, Viret J F, Schottstedt V, Lankinen M, Da Silva Cardoso M, Lelie P N
Abstract excerpt
The NucliSens Extractor in combination with the 2.0 version of the Roche Cobas HCV Amplicor test has been validated by five European blood screening laboratories in a multi-centre study. For testing the performance characteristics of this HCV-NAT method, the European Pharmacopoeia validation guidelines were followed. The CLB VQC reference reagents were used for testing robustness and sensitivity. After a...
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