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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.

cobas® HCV is a quantitative test performed on the cobas® 5800 system, cobas® 6800 system and cobas® 8800 system. cobas® HCV enables the detection and quantitation of HCV RNA in EDTA plasma or serum of infected patients. Dual probes are used to detect and quantify, but not discriminate genotypes 1–6. The viral load is quantified against a non-HCV armored RNA quantitation standard (RNA-QS), which is introduced into each specimen during sample preparation. The RNA-QS also functions as an internal control to assess substantial failures during the sample preparation and PCR amplification processes. In addition, the test utilizes three external controls: a high titer positive, a low titer positive, and a negative control.

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