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Evaluation of a New-Generation Line-Probe Assay That Detects 5' Untranslated and Core Regions to Genotype and Subtype Hepatitis C Virus

Rohan Nadarajah MT(ASCP), G. Yasmeen Khan MT(ASCP), Steven A. Miller MD, PhD, Geo F. Brooks MD
DOI: http://dx.doi.org/10.1309/RBAAC0HJFWRJB1HD 300-304 First published online: 1 August 2007


The VERSANT HCV Genotype 2.0 Assay (LiPA 2.0; Innogenetics, Ghent, Belgium; distributed by Siemens Medical Solutions Diagnostics, Tarrytown, NY) is a new-generation line-probe assay that simultaneously detects sequences in the 5' untranslated (5'UTR) and core regions to genotype and subtype hepatitis C virus (HCV). We tested 60 specimens of known genotype and subtype and 2 specimens with mixed infections with the LiPA 2.0 assay. After arbitration based on genotype and subtype determined by sequencing, there was concordance in 58 of 60 specimens (specificity, 96.7%). Computer-assisted typing yielded comparable results, but much more rapidly. Of 67 clinical specimens, 64 readily yielded genotype and subtype; 3 indeterminate specimens were typed by sequencing and were uncommon types not in the database. The new-generation line-probe assay that detects the 5'UTR and core regions to genotype and subtype HCV is applicable to more than 95% of specimens. Interpretation is facilitated by computer-assisted analysis.

Key Words:
  • Hepatitis C virus
  • Genotyping
  • Line-probe assay
  • 5’ Untranslated region
  • Core region