JCM Accepts, published online ahead of print on 9 April 2008

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J. Clin. Microbiol. doi:10.1128/JCM.02390-07
Copyright (c) 2008, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

EVALUATION OF THE VERSANT HCV GENOTYPE ASSAY (LiPA) 2.0

Jannick Verbeeck, Mark J. Stanley, Jen Shieh, Linda Celis, Els Huyck, Elke Wollants, Judy Morimoto, Alice Farrior, Erwin Sablon, Margaret Jankowski-Hennig, Carl Schaper, Pamela Johnson, Marc Van Ranst^*, and Marianne Van Brussel

Laboratory of Clinical Virology, Rega Institute for Medical Research, Leuven, Belgium; Department of Microbiology, Kaiser Permanente, TPMG Regional Laboratory, Berkeley, CA, USA; Innogenetics NV, Gent, Belgium; Siemens Healthcare Diagnostics, Berkeley, CA, USA

^* To whom correspondence should be addressed. Email: marc.vanranst{at}uz.kuleuven.ac.be.

Hepatitis C virus genotyping is a tool used to optimize antiviral treatment regimens. The newly developed VERSANT® HCV Genotype Assay (LiPA) 2.0 uses sequence information from both the 5'UTR and the core region, allowing distinction between HCV genotype 1 and subtypes c-l of genotype 6, and between subtypes a and b of genotype 1. HCV positive samples were genotyped manually using the VERSANT® HCV Genotype Assay (LiPA) 2.0 system according to the manufacturer's instructions. For the comparison study, the VERSANT® HCV Genotype Assay (LiPA) 1.0 was used. 99.7% of the samples could be amplified, the genotype of 96.0% of samples could be determined, and the agreement with the reference method was 99.4% when a genotype was determined. The reproducibility study showed no significant differences in performance across sites (p=0.43) or across lots (p=0.88). In the comparison study, 13 samples that were uninterpretable or incorrectly genotyped with the VERSANT® HCV Genotype Assay (LiPA) 1.0, were correctly genotyped by the VERSANT® HCV Genotype Assay (LiPA) 2.0. The VERSANT® HCV Genotype Assay (LiPA) 2.0 is a sensitive, accurate, and reliable assay for HCV genotyping. The inclusion of the core region probes in the VERSANT® HCV Genotype Assay (LiPA) 2.0 results in a higher genotyping success rate than the current VERSANT® HCV Genotype Assay (LiPA) 1.0.