Roche’s HCV qualitative and quantitative tests have received CE mark. The tests, based on the firm’s Cobas platform, detect HCV RNA, which is a crucial marker in the management of hepatitis C infection. Cobas AmpliPrep/Cobas TaqMan HCV Qualitative Test v2.0 is intended for the confirmation of HCV antibody positive specimens. Cobas AmpliPrep/Cobas TaqMan HCV Quantitative Test v2.0 is intended for viral load monitoring and the prediction of virological response to antiviral therapy. Both tests are reportedly standardized with the World Health Organization (WHO) international standard and have a limit of detection and lower limit of quantitation of 15 IU/mL.
