cobas HCV (cobas 5800/6800/8800) - 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, genotypes 1 to 6, in human EDTA plasma or serum of HCV-infected individuals.

Functional description

The viral load is quantified against a non-HCV armored RNA quantitation standard (RNA-QS), which is introduced into each specimen during sample preparation. The RNA-QS also functions as an internal control to monitor the entire sample preparation and PCR amplification process. Three external controls are also utlised.