cobas HCV for use on the cobas 4800 System - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Intended purpose

cobas® HCV is an in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human EDTA plasma or serum, of HCV-infected individuals.

Functional description

cobas® HCV enables the detection and quantitation of HCV RNA in EDTA plasma or serum of infected patients. HCV genotypes 1-6 are detected and quantified but not discriminated. A non-HCV armored RNA quantitation standard (RNA-QS) is introduced into each specimen during sample preparation, and is used to quantify the viral load and act as an internal control to monitor the entire sample preparation and PCR amplification process. Three external controls are also employed.