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

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.

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.

Features and Benefits

  • Hepatitis C Virus (HCV) exists as 67 known subtypes which have been classified into seven genotypes varying by 31– 33% at the nucleotide level. There are multiple subtypes within each genotype that vary by 20 –25 %. Based on prevalence only genotypes 1-6 are of clinical relevance.
  • HCV genotypes and subtypes are distributed throughout the world with various genotypes dominating in specific geographic areas.
  • Identification of the infecting genotype is required before a patient is prescribed antiviral therapy as response to treatment correlates to the HCV genotype. Determination of HCV genotype prior to treatment initiation has been implemented in international HCV treatment guidelines.

Excellent genotyping and subtyping accuracy compared to sequencing

  • Overall genotype accuracy: 99.7%
  • Overall subtype (1a/1b) accuracy: 100%

Intended Use

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. cobas® HCV GT is not intended for use as a screening test for the presence of HCV in blood or blood products or as a diagnostic test to confirm the presence of HCV infection.·