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

Delivering on clinical need requirements

Determining HCV genotype

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

Features

  • 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

Intended use

(CE-IVD)

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.

Performance

Parameters Performances
Sample type EDTA plasma, serum
Sample processing volume 400 µL
Genotype accuracy Gentoypes 1 to 6: 99.7%; Genotype 1 subtype 1a and 1b:100%
Genotypes detected HCV genotypes 1 – 6 and genotype 1 subtypes a and b

Precise genotyping for successful treatment

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.

References:

  1. World Health Organization (WHO). Fact sheet No. 164: Hepatitis C. http://www.who.int/mediacentre/factsheets/fs164/en/. Accessed May 13, 2016.
  2. EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol. 2017;66(1):153–194.
  3. AASLD HCV Guidance. Hepatitis C Guidance: AASLD-IDSA Recommendations for Testing, Managing, and Treating Adults Infected With Hepatitis C Virus. Hepatology. 2015.
  4. cobas® HCV GT for use on the cobas® 4800 System package insert.