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cobas® HCV for use on the cobas® 4800 System

Innovative, dual-probe HCV viral load testing

See what truly matters when testing for HCV

A quantitative hepatitis C virus (HCV) RNA test must be able to tolerate sequence mismatches for accurate and reliable results. The combination of error-prone RNA replication and a high rate of virus production results in extreme genetic variability of HCV. Clinicians rely on regular HCV viral load assessment to achieve an optimal treatment outcome.

The cobas® HCV quantitative nucleic acid test delivers robust, clinically relevant assay performance based on the proprietary dual-probe assay design from Roche. cobas® HCV is designed to deliver high sensitivity to meet the requirements of current and future chronic hepatitis C therapies combined with an efficient workflow for laboratories.

The innovative, state-of-the-art dual-probe HCV viral load assay precisely distinguishes true signals from background noise leading to more accurate quantification of viral loads.

Features

  • Accurate detection and quantification of HCV genotypes 1 through 6
  • Clinically validated for use with new HCV therapies
  • Excellent correlation with the COBAS®AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, v2.0

Optimized clinical decisions through precise HCV viral load assessment

  • Accurate HCV RNA viral load results are important for monitoring patients treated with the DAAs to decide on continuation of therapy and assess treatment success
  • The Roche HCV dual-probe assay helps clinicians to better manage HCV patients facilitating optimized clinical decision

Intended use

CE-IVD

cobas® HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus RNA, in human EDTA plasma or serum, of HCV-infected individuals. Specimens containing HCV genotype 1 to 6 are validated for detection and quantitation in the assay.

The test is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.

The test is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy. The results must be interpreted within the context of all relevant clinical and laboratory finding.

Performance

Parameters Performances
Sample type EDTA plasma, serum
Sample processing volume 400 µL or 200 µL
Analytical sensitivity in EDTA Plasma 9.2 IU/mL (400 µL);
15.3 IU/mL (200 µL)
Linear range 400 µL: 15 IU/mL – 1 x 108 IU/mL
200 µL: 25 IU/mL – 1 x 108 IU/mL
Specificity 99.5% (95% confidence limit ≥ 98.7%)
Genotypes detected HCV genotypes 1-6

Accurate quantification and detection for an ever-changing virus

Every day, approximately 4,000 people die from the consequences of viral hepatitis, and 1.4 million people every year.1 Turn to cobas® HCV for the cobas® 4800 System for precise, dual-probe HCV viral load testing.

Reference: 

  1. World Health Organization (WHO). World Hepatitis Day. http://www.who.int/campaigns/hepatitis-day/2016/event/en. Accessed July 2016.