Evaluation of a new-generation line-probe assay that detects 5' untranslated and core regions to genotype and subtype hepatitis C virus.
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 newgeneration 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.
Nadarajah
Rohan
R
Microbiology Section, Clinical Laboratories, Department of Laboratory Medicine, University of California San Francisco, CA 94107, USA.
Khan
G Yasmeen
GY
Miller
Steven A
SA
Brooks
Geo F
GF
D020121:5' Untranslated Regions / Q000235:genetics*; D003429:Cross Reactions; D005838:Genotype; D016174:Hepacivirus / Q000145:classification* / Q000235:genetics; D006801:Humans; D009693:Nucleic Acid Hybridization / Q000379:methods*; D016133:Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D014758:Viral Core Proteins / Q000235:genetics*
D020121:5' Untranslated Regions; D014758:Viral Core Proteins