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Journal of Clinical Microbiology, June 2008, p. 1901-1906, Vol. 46, No. 6
0095-1137/08/$08.00+0     doi:10.1128/JCM.02390-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Evaluation of Versant Hepatitis C Virus Genotype Assay (LiPA) 2.0{triangledown}

Jannick Verbeeck,1 Mark J. Stanley,2 Jen Shieh,2 Linda Celis,3 Els Huyck,3 Elke Wollants,1 Judy Morimoto,2 Alice Farrior,2 Erwin Sablon,3 Margaret Jankowski-Hennig,4 Carl Schaper,4 Pamela Johnson,4 Marc Van Ranst,1* and Marianne Van Brussel3

Laboratory of Clinical Virology, Rega Institute for Medical Research, Leuven, Belgium,1 Department of Microbiology, Kaiser Permanente, TPMG Regional Laboratory, Berkeley, California,2 Innogenetics NV, Gent, Belgium,3 Siemens Healthcare Diagnostics, Berkeley, California4

Received 12 December 2007/ Returned for modification 11 February 2008/ Accepted 31 March 2008

Hepatitis C virus (HCV) 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' untranslated region and the core region, allowing distinction between HCV genotype 1 and subtypes c to 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, Versant HCV genotype assay (LiPA) 1.0 was used. In this study, 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 Versant HCV genotype assay (LiPA) 1.0 were correctly genotyped by Versant HCV genotype assay (LiPA) 2.0. 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 Versant HCV genotype assay (LiPA) 2.0 results in a genotyping success rate higher than that of the current Versant HCV genotype assay (LiPA) 1.0.

* Corresponding author. Mailing address: Laboratory of Clinical & Epidemiological Virology, Rega Institute for Medical Research, University of Leuven, Minderbroedersstraat 10, BE-3000 Leuven, Belgium. Phone: 32-16-347908. Fax: 32-16-332131. E-mail: marc.vanranst{at}uz.kuleuven.ac.be

{triangledown} Published ahead of print on 9 April 2008.

Journal of Clinical Microbiology, June 2008, p. 1901-1906, Vol. 46, No. 6
0095-1137/08/$08.00+0     doi:10.1128/JCM.02390-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.





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