COBAS® AmpliPrep/COBAS® TaqMan® HCV Test

COBAS® AmpliPrep/COBAS® TaqMan® HCV Test

The COBAS® AmpliPrep/COBAS® TaqMan® HCV Test is an in vitro nucleic acid amplification test for the quantitation of hepatitis C virus (HCV) RNA in human plasma or serum using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or the COBAS®TaqMan®48 Analyzer for automated amplification and detection. The test is intended for use in conjunction with clinical presentation and other laboratory markers of HCV infection for the clinical management of patients with chronic HCV. The test can be used to assess the probability of a sustained viral response early in a course of antiviral therapy and to assess viral response to antiviral treatment as measured by changes in serum or plasma HCV RNA levels.