cobas^® HCV GT for use on the cobas^® 4800 System

The determination of hepatitis C virus (HCV) genotype prior to treatment initiation has been implemented in international HCV treatment guidelines.^1-3

cobas^® HCV GT is a highly sensitive, real-time PCR based test for the qualitative identification of HCV genotypes 1 to 6 and genotype 1 subtypes A and B in human plasma or serum from individuals with chronic HCV infection, using the cobas^® 4800 System.⁴

cobas^® HCV GT uses three different target regions in the HCV genome (5’-UTR, Core, NS5B) to achieve excellent genotyping and subtyping accuracy compared to sequencing and the capability to detect both genotypes in mixed infections down to a ratio of 1:100.⁴

• Correctly detects minor genotype in mixed infections on average at 86% (10:1 mixtures) and 63% (100:1 mixtures)
• cobas^® HCV GT can complete 3 runs in an 8-hour shift with 60% less hands-on time, allowing for a maximum of throughput of 90 specimens/day
• Optimized assay design with minimal manual intervention and hands-on time

The cobas^® HCV GT is an in vitro nucleic acid amplification test for the qualitative identification of hepatitis C Virus (HCV) genotypes 1 to 6 and genotype 1 subtypes a and b in human plasma or serum from individuals with chronic HCV infection, using the cobas^® 4800 System, the cobas x 480 Instrument for automated specimen processing and the cobas z 480 Analyzer for automated amplification and detection. cobas^® HCV GT is intended for use in selecting individuals with chronic HCV infection for antiviral therapy and in determining the duration of therapy regimens according to the antiviral therapy prescribing information.

Approximately 130–150 million people globally have a chronic hepatitis C infection, with 3 to 4 million new infections occurring each year.¹ Rely on cobas^® HCV GT for the cobas^® 4800 System for precise genotyping to define treatment in keeping with international guidelines.

CE-IVD

Access package inserts through your country’s Roche Diagnostics Website.