cobas® HCV Test

Product image for cobas® HCV Test

Innovative, dual-probe HCV viral load testing for the cobas® 4800/5800/6800/8800 Systems

Accurate quantification and detection for an ever-changing virus

 

Every day, approximately 3,000 people die from the consequences of viral hepatitis, and 1.1 million people every year1 Roche is committed to fighting viral hepatitis with effective diagnosis and monitoring. For hepatitis C, cobas® HCV for use on the cobas ® 4800/5800/6800/8800 Systems, offers precise, dual-probe HCV viral load testing to accurately identify disease and determine patient response to treatment.

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

Optimised 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

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 utilised 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. 

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. 

Registration status

cobas® HCV for 4800/5800/6800/8800 Systems: CE-IVD 

cobas® HCV for 6800/8800 Systems: US-IVD

 

Package inserts

Access package inserts through your country’s Roche Diagnostics Website.

 

Reference

 

  1. Global progress report on HIV, viral hepatitis and sexually transmitted infections, 2021. https://www.who.int/publications/i/item/9789240027077. Accessed December 2021.

cobas® 4800 System* Performance

  • Sample type

    EDTA plasma, serum

  • Minimum amount of sample required

    400 µL or 200 µL

  • Analytical sensitivity in EDTA plasma

    9.2 lU/mL (400 µL)
    15.3 lU/mL (200 µL)

  • Linear range

    400 µL: 15 lU/mL - 1.0 x 10IU/mL
    200 µL: 25 lU/mL - 1.0 x 10IU/mL

  • Performance with HBV DNA-negative samples

    99.5% (95% confidence interval ≥ 98.7%)

  • Specificity

    HCV genotypes 1-6

cobas® 5800*/6800/8800 Systems Performance

  • Sample type

    EDTA plasma, serum

  • Minimum amount of sample required

    650 µL

  • Sample processing volume

    500 µL or 200 µL

  • Analytical sensitivity (LoD by hit rate of ≥95%)

    500 μL: 15 IU/mL   200 μL: 40 IU/mL **

  • Linear range

    500 μL: 15 IU/mL – 1x108 IU/mL  200 μL: 40 IU/mL – 1x108 IU/mL **

  • Specificity

    100% (one-sided 95% confidence interval: 99.5%)

  • Genotypes detected

    HCV genotypes 1-6

*Not available in the United States.

**200 μL volume not commercially available in the United States.