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

See what truly matters

The cobas® HCV quantitative nucleic acid test for use on the cobas® 6800/8800 Systems delivers robust, clinically relevant assay performance based on Roche’s proprietary dual-probe assay design.

cobas® HCV provides built-in redundancy with broad genotype coverage and incorporates mismatch tolerance to ensure confidence in viral load monitoring.

cobas® HCV is designed to deliver high sensitivity to meet the requirements of current and future chronic hepatitis C therapies.

HCV – an ever changing virus

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.

Features and Benefits

  • Tight precision at medically-relevant decision points
  • Accurate detection and quantification of HCV genotypes 1 through 6
  • High sensitivity suitable for use with new HCV therapies
  • Excellent correlation with the COBAS® AmpliPrep/COBAS® TaqMan® HCV Quantitative Test, v2.0

Intended Use

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

The cobas® HCV 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 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 (HCV) 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.

Learn more at www.cobas68008800.com/assay_menu

cobas® 6800/8800 Systems are not available in all markets, including the U.S.