Xpert HCV VL FS Assay, kit/10

General description:
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 venous and capillary fingerstick EDTA whole blood from patients with a suspicion of HCV infection 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. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. 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. The assay is not intended to be used as a blood donor screening test for HCV.

Manufacture product reference: Cepheid AB, GXHCV-FS-CE-10 (Regulatory version: CE)

Items supplied with:
·10 cartridges x HCV VL FS Assay cartridges with integrated reaction tubes
·1 x CD

Items required, but not supplied:
·GeneXpert Dx System or GeneXpert Infinity Systems (catalog number varies by configuration): GeneXpert Instrument, computer with proprietary GeneXpert Dx Software Version 4.7b or higher (GeneXpert Dx systems); or Xpertise 6.4b or higher (Infinity-80/Infinity-48s), barcode scanner, and operator manual
·Printer: If a printer is needed, contact Cepheid Technical Support to arrange for the purchase of a recommended printer
·Bleach or sodium hypochlorite
·Ethanol or denatured ethanol
·Disposable Minivette® POCT 100 μL K3E (P/N: MINIVETTE 100E-100, 100 per box)
·Disposable Safety-Lancet Super, 1.5 mm (Sarstedt, P/N: 85.1018 or similar)

Shelf life:
12 months upon manufacture.

Weight & volume:
Estimated weight: 0.8kg
Estimated volume: 0.011dm3

Storage & transportation condition:
Must be stored at 2-28°C.

Packaging & labelling:
Primary packaging: All contents of Xpert HCV VL FS Assay, kit of 10 tests
Secondary packaging: One kit Xpert HCV VL FS Assay, kit/10 tests