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cobas® HCV for use on the cobas® 6800/8800 Systems

See what truly matters when assessing HCV viral load

Monitor using an innovative, dual-probe HCV viral load test

The combination of error-prone RNA replication and a high rate of virus production results in extreme genetic variability of the hepatitis C virus (HCV). A quantitative HCV RNA test must be able to tolerate sequence mismatches for accurate and reliable results.

Roche has been at the forefront of viral load monitoring tests for hepatitis and continues to provide a robust assay design to ensure accurate and reliable results to optimize patient management and treatment success. 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 Roche’s proprietary dual-probe assay design. It delivers reliable results 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

Precise HCV viral load assessment, optimized clinical decisions

  • Accurate HCV RNA viral load results are particularly 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

HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C RNA, genotypes 1 to 6, in human EDTA plasma or serum of HCV-infected individuals.

cobas® HCV 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 in the management of patients with chronic HCV in conjunction with clinical and laboratory markers of infection. The test can be used to predict the probability of sustained virologic response (SVR) early during a course of antiviral therapy, and to assess viral response to antiviral treatment (response guided therapy) as measured by changes of HCV RNA levels in serum or EDTA plasma. The results must be interpreted within the context of all relevant clinical and laboratory finding.

US-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 antibody positive or HCV-infected individuals. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay.

cobas® HCV 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.

cobas® HCV is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy. The assay can be used to measure HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of follow up of treatment to determine sustained or non-sustained viral response. The results must be interpreted within the context of all relevant clinical and laboratory findings.

cobas® HCV has not been approved for use as a screening test for the presence of HCV in blood or blood products.

Assay performance characteristics have been established for individuals treated with certain direct-acting antiviral agents (DAA) regimens. No information is available on the assay’s predictive value when other DAA combination therapies are used.

Performance*

Parameters Performances
Sample type EDTA plasma, serum
Sample processing volume 500 µL
Analytical sensitivity EDTA plasma: 12.0 IU/mL
Linear range 15 IU/mL – 1 x 108 IU/mL
Specificity 100% (two-sided 95% confidence limit: 99.4%-100%)
Genotypes detected HCV genotypes 1-6
*US-IVD data only

Accurately quantify and detect HCV

Every day, approximately 4,000 people die from the consequences of viral hepatitis, and 1.4 million people every year.1 Get robust and clinically relevant assay performance from a pioneer in the field of HCV viral load testing, with cobas® HCV for the cobas® 6800/8800 Systems.

References:

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