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Hepatitis C Virus (HCV) Quantification, automated format

COBAS® AMPLICOR HCV MONITOR Test, v2.0 **** (CE-IVD)

The COBAS® AMPLICOR HCV MONITOR Test, v2.0 is an in vitro nucleic acid amplification test for the quantitation of hepatitis C virus RNA in human serum or plasma on the COBAS® AMPLICOR® Analyzer. The test is intended for use in conjunction with clinical presentation and other laboratory markers as an aid in assessing viral response to antiviral treatment as measured by changes in serum or plasma HCV RNA levels. Study results continue to show a lower sustained virological response in patients with genotype 1 infections, higher HCV RNA levels, or more advanced stages of fibrosis. In genotype 1 infections, the lack of an early virologic response (< 2 log decrease in HCVRNA) is associated with failure to achieve a sustained virological response. The absence of detectable serum HCV RNA after treatment has been associated with resolution of liver injury, reduction in hepatic fibrosis, and a low likelihood of a relapse of the HCV infection1,2,3.

The COBAS® AMPLICOR HCV MONITOR Test, v2.0 is not intended for use in screening blood or blood products for the presence of HCV or as a diagnostic test to confirm the presence of HCV infection.

The COBAS® AMPLICOR HCV MONITOR Test, v2.0 allows for the:

  • Quantification of HCV RNA over the range of 600 to 700,000 IU/mL
  • Measuring of changes in serum or plasma HCV RNA levels, including HCV genotypes 1 through 6
  • Sensitivity, reliability and standardization in every test
  • Ability to monitor viral response to antiviral treatment in patients infected with HCV
  • Automated HCV quantification which may contribute to greater laboratory productivity

1 Consensus Statement. EASL International Consensus Conference on Hepatitis C. Paris, 26-28 February 1999. J Hepatol 1999; 31 Suppl 1:3-8.

2 National Institutes of Health Consensus Development Conference Statement Management of Hepatitis C: 2002. June 10-12, 2002.

3 Consensus Statement. AFEF Conference on Treatment of Hepatitis C. Paris. February 27-28, 2002.

**** Available as an IVD in the EU and for Research Use Only in the United States

 
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