Intended Use

Detection and quantification of HCV (genotypes 1-6) RNA in human serum for the following scenarios:

Aid in diagnosis of active HCV in:

• Individuals with antibody evidence of HCV with evidence of liver disease
• Individuals suspected to be actively infected with HCV antibody evidence
• individuals at risk for HCV infection with antibodies to HCV

Aid in management of HCV-infected patients undergoing viral therapy to measure HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of followup of treatment to determine sustained of non-sustained viral response.  The results must be interpreted within the context of all relevant clinical and laboratory findings.