Intended Use

For detection of quantification of hepatitis C viral RNA in serum before, during and after antiviral therapy for chronic hepatitis C.

Detection of acute hepatitis C virus (HCV) infection before the appearance of HCV antibodies in serum (ie, <2 months from exposure).

Detection and confirmation of chronic HCV infection.

Quantification of HCV RNA in serum of patients with chronic HCV infection (HCV antibody-positive).

Monitoring disease progression in chronic HCV infection and response to antiviral therapy.

Determining cure and detection of relapse after completion of antiviral therapy.