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Publication – The Cobas AmpliPrep/Cobas TaqMan HCV Test, Version 2.0, Real-Time PCR Assay Accurately Quantifies Hepatitis C Virus Genotype 4 RNA

The aim of this study was to evaluate the ability of the Cobas AmpliPrep/Cobas TaqManHCV test, version 2.0 (CAP/CTMHCVv2.0), to accurately quantify HCVRNAin 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 whomHCVRNAwas undetectable using the CAP/CTM HCV.

Each specimen was tested with the third-generation branched DNA(bDNA) assay, CAP/CTM HCV, and CAP/CTMHCVv2.0. TheHCVRNAlevel was lower in CAP/CTMHCVthan inbDNAin 76.2% of cases, regardless of the HCV genotype 4 subtype. In contrast, the correlation between DNA and CAP/CTMHCVv2.0 values was excellent.

CAP/CTMHCVv2.0 accurately quantifiedHCVRNAlevels 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 the HCV genome.

In conclusion, CAP/CTMHCVv2.0 accurately quantifiesHCVRNAin genotype 4 clinical specimens, regardless of the subtype, and can be confidently used in clinical trials and clinical practice with this genotype.