GXHCV-FS-CE-10 - Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)

Intended purpose

The Xpert HCV VL Fingerstick (FS) assay is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Hepatitis C Virus (HCV) RNA in human capillary fingerstick EDTA whole blood and venous EDTA whole blood from HCV-infected individuals using the automated GeneXpert® Instrument Systems. The Xpert HCV VL FS assay is intended for use as an aid in the initial diagnosis in individuals at high risk of HCV infection or in anti-HCV positive individuals. The Xpert HCV VL FS assay is intended for use as an aid in the management of HCV infected patients undergoing antiviral therapy. The Xpert HCV VL FS assay is intended to be used by laboratory professionals or specifically-trained healthcare workers

Functional description

The Xpert HCV VL Fingerstick (FS) assay is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Hepatitis C Virus (HCV) RNA in human capillary fingerstick EDTA whole blood and venous EDTA whole blood from HCV-infected individuals using the automated GeneXpert® Instrument Systems. The Xpert HCV VL FS assay is intended as an aid in the initial diagnosis in individuals at high risk of HCV infection or in anti-HCV positive individuals.