APTIMA HCV QUANT DX ASSAY KIT - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Intended purpose

The Aptima HCV Quant Dx assay is indicated as an aid in the diagnosis of HCV infection. The assay confirms active HCV infection in patients with a positive HCV antibody result. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection.The Aptima HCV Quant Dx assay is also indicated as an aid in the management of HCV infected patients undergoing HCV antiviral drug therapy. The results from the Aptima HCV Quant Dx assay must be interpreted within the context of all relevant clinical and laboratory findings. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay.

Functional description

The Aptima HCV Quant Dx assay is a real-time transcription-mediated amplification test. This assay is used for both detection and quantitation of hepatitis C virus (HCV) RNA in fresh and frozen human serum and plasma from HCV-infected individuals.