The HCV RNA Viral Load assay is a reverse transcription-polymerase chain reaction (RT-PCR) assay for the quantitation of hepatitis C viral (HCV) RNA in human serum or plasma (EDTA) from HCV-infected individuals. This assay is intended for use as an aid in the management of HCV-infected patients undergoing antiviral 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 from the RT-HCV assay must be interpreted within the context of all relevant clinical and laboratory findings. The Abbott RT-HCV assay is not for screening blood, plasma, serum or tissue donors for HCV.