The Cobas AmpliPrep/Cobas TaqMan HCV test, version 2.0, real-time PCR assay accurately quantifies hepatitis C virus genotype 4 RNA.

Abstract

Accurate hepatitis C virus (HCV) RNA quantification is mandatory for the management of chronic hepatitis C therapy. The first-generation Cobas AmpliPrep/Cobas TaqMan HCV test (CAP/CTM HCV) underestimated HCV RNA levels by >1-log10 international units/ml in a number of patients infected with HCV genotype 4 and occasionally failed to detect it. The aim of this study was to evaluate the ability of the Cobas AmpliPrep/Cobas TaqMan HCV test, version 2.0 (CAP/CTM HCV v2.0), to accurately quantify HCV RNA in a large series of patients infected with different subtypes of HCV genotype 4. Group A comprised 122 patients with chronic HCV genotype 4 infection, and group B comprised 4 patients with HCV genotype 4 in whom HCV RNA was undetectable using the CAP/CTM HCV. Each specimen was tested with the third-generation branched DNA (bDNA) assay, CAP/CTM HCV, and CAP/CTM HCV v2.0. The HCV RNA level was lower in CAP/CTM HCV than in bDNA in 76.2% of cases, regardless of the HCV genotype 4 subtype. In contrast, the correlation between bDNA and CAP/CTM HCV v2.0 values was excellent. CAP/CTM HCV v2.0 accurately quantified HCV RNA levels in the presence of an A-to-T substitution at position 165 alone or combined with a G-to-A substitution at position 145 of the 5' untranslated region of HCV genome. In conclusion, CAP/CTM HCV v2.0 accurately quantifies HCV RNA in genotype 4 clinical specimens, regardless of the subtype, and can be confidently used in clinical trials and clinical practice with this genotype.

• Authors: Stéphane Chevaliez, Magali Bouvier-Alias, Christophe Rodriguez, Alexandre Soulier, Jean-Dominique Poveda, Jean-Michel Pawlotsky
• Journal: Journal of clinical microbiology (J Clin Microbiol) Vol. 51 Issue 4 Pg. 1078-82 (Apr 2013) ISSN: 1098-660X [Electronic] United States
• PMID: 23325825 (Publication Type: Evaluation Study, Journal Article)

Chemical References

• RNA, Viral

Topics

• Genotype
• Hepacivirus (genetics, isolation & purification)
• Hepatitis C, Chronic (diagnosis, virology)
• Humans
• RNA, Viral (genetics, isolation & purification)
• Real-Time Polymerase Chain Reaction (methods)
• Viral Load (methods)