Xpert HCV VL - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Intended purpose

The HCV VL assay, performed on GeneXpert® Instrument Systems, is designed for the rapid quantitation of Hepatitis C Virus (HCV) RNA in human serum or plasma (EDTA) from HCV-infected individuals. The test utilizes automated reverse transcriptase polymerase chain reaction (RT-PCR) using fluorescence to detect the RNA of interest for the quantitation of HCV. The HCV VL assay is intended for use as an aid in the management of HCV infected patients undergoing antiviral therapy. Results from the HCV VL assay may also be used to confirm HCV infection in anti-HCV positive individuals. The assay is intended to be used by laboratory professionals or specifically-trained healthcare workers.

Functional description

The HCV VL assay, performed on GeneXpert® Instrument Systems, is designed for the rapid quantitation of Hepatitis C Virus (HCV) RNA in human serum or plasma (EDTA) from HCV-infected individuals. The test utilizes automated reverse transcriptase polymerase chain reaction (RT-PCR) using fluorescence to detect the RNA of interest for the quantitation of HCV. The HCV VL assay is intended for use as an aid in the management of HCV infected patients undergoing antiviral therapy.