cobas® HCV for use on the cobas® 4800 System

See what truly matters

cobas® HCV, quantitative nucleic acid test for use on the cobas® 4800 System, delivers robust, clinically relevant assay performance based on the proprietary dual-probe assay design from Roche with built-in redundancy for broad genotype coverage and improved 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 combined with an efficient workflow for laboratories.

Features and Benefits

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.

cobas® HCV accurately detects and quantifies all HCV genotypes 1 through 6

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

Clinical relevance

Clinicians rely on regular HCV viral load assessment to achieve an optimal treatment outcome. Depending on the treatment regimen, HCV RNA measurements are made at baseline to identify likely treatment responders, to assess patient adherence during therapy, to determine if the treatment should be abbreviated or abandoned (futility rules) or that treatment has been successful and sustained virological response (SVR) has been achieved.

cobas® HCV delivers:

  • 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.

Furthermore, cobas® HCV is approved as an aid in the diagnosis of HCV to confirm active infection in individuals with HCV antibody evidence.

Intended Use

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-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.