411530 - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Intended purpose

Cobas® HCV DBS, performed on the Roche Cobas 6800 system by a trained laboratory operator, is an in vitro Hepatitis C virus (HCV) nucleic acid amplification test for the qualitative detection of HCV RNA, genotypes 1 to 3, in human dried blood spot (DBS) specimens of HCV-infected individuals.

Functional description

Cobas® HCV DBS enables the qualitative detection of hepatitis C virus (HCV) RNA in dried blood spot (DBS) of infected patients. HCV genotypes 1-3 are detected but not discriminated. Three external controls are used, and an internal control is introduced into each specimen to monitor the entire sample preparation and PCR amplification process.