Evaluation of Versant hepatitis C virus genotype assay (LiPA) 2.0.
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.
Verbeeck
Jannick
J
Laboratory of Clinical & Epidemiological Virology, Rega Institute for Medical Research, University of Leuven, Minderbroedersstraat 10, BE-3000 Leuven, Belgium.
Stanley
Mark J
MJ
Shieh
Jen
J
Celis
Linda
L
Huyck
Els
E
Wollants
Elke
E
Morimoto
Judy
J
Farrior
Alice
A
Sablon
Erwin
E
Jankowski-Hennig
Margaret
M
Schaper
Carl
C
Johnson
Pamela
P
Van Ranst
Marc
M
Van Brussel
Marianne
M
D020121:5' Untranslated Regions / Q000235:genetics; D005838:Genotype; D016174:Hepacivirus / Q000145:classification* / Q000235:genetics*; D006526:Hepatitis C / Q000821:virology; D006801:Humans; D009693:Nucleic Acid Hybridization / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D017422:Sequence Analysis, DNA; D013997:Time Factors; D014758:Viral Core Proteins / Q000235:genetics
D020121:5' Untranslated Regions; D011933:Reagent Kits, Diagnostic; D014758:Viral Core Proteins