cobas® HCV Test

Product image for cobas® HCV Test

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.

Accurate quantification and detection for an ever-changing virus

 

HCV — An ever-changing virus
Accurately detect and quantitate all HCV genotypes 1 through 6

 

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

  • Two non-overlapping detection probes, when combined with two staggered primers, ensure assay performance with HCV isolates containing sequence heterogeneity.
  • Mismatch tolerance enables the test to accurately quantify the target despite nucleotide changes in the viral genome while maintaining high specificity for HCV RNA.
RNA-image

Reference

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

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® 6800/8800 Systems** Performance

  • Sample type

    EDTA plasma, serum

  • Minimum amount of sample required

    650 µL

  • Sample processing volume

    500 µL

  • Analytical sensitivity

    EDTA plasma: 12.0 lU/mL

    Serum: 13.7 lU/mL

  • Linear range

    15 lU/mL - 1.0 x 10IU/mL

  • Performance with HBV DNA-negative samples

    100.0% (two-sided 95% confidence limit: 99.4% - 100%)

  • Specificity

    HCV genotypes 1-6

cobas® HCV Test Innovation Review

View Full Table

cobas® HCV Test Innovation Review

Key improvements in simplicity and functionality

  cobas 6800/8800 Systems Benefits
CLIA complexity categorization
Moderate
Increases flexibility with personnel
Tests per package
96
 
Control packaging
Packaged separately
Reduces waste
Onboard open reagent stability
30 days
 

cobas® HCV Test Performance Summary

View Full Table

cobas® HCV Test Performance Summary

Gold Standard Performance with additional benefits

  cobas® 6800/8800 Systems
HCV
cobas® 6800/8800 systems
Intended use 1. Diagnosis of chronic HCV infection 
2. Monitoring patients on HCV therapy 
3. Assessment of SVR
CLIA complexity categorization Moderate
Linear range 15- 1.E+08 IU/mL
Analytical sensitivity (LOD by probit analysis)
EDTA plasma (IU/mL)
12*
Serum (IU/mL) 13.7*
Packaging HCV test-specific reagent (96 tests/kit)
Control packaging
Packaged separately
Genotypes covered Genotypes 1-6
Primer and probe design Dual probe
Sample types Serum, EDTA & PPT Plasma
Sample size 650 uL
Contamination control with AmpErase Yes
Specificity 100%
Intended use

Intended use

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. 

The cobas® HCV assay detects and quantitates HCV RNA and 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 cobas® HCV assay is intended for use in the management of patients with chronic HCV undergoing anti-viral therapy:

  • 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.
  • Results must be interpreted within the context of all relevant clinical and laboratory findings.

Related systems

cobas® 4800 System image

cobas® 4800 System

Highly efficient, flexible workflows and a consolidated assay menu deliver confidence with every result. Automated PCR setup and analysis help make the most of your resources and reduce error.

More
cobas® 6800 System image

cobas® 6800 System

Transform your testing experience for IVD applications—just 2 simple user interactions per run and up to 8 hours of walk-away time.

More
cobas® 8800 System image

cobas® 8800 System

Unparalleled performance with minimal operator interaction revolutionises the future of high-throughput applications. 

More