Xpert HIV-1 VL XC, Kit/10

General description:
Xpert HIV-1 Viral Load XC (Extended Coverage) is an in vitro reverse transcription polymerase chain reaction (RT-PCR) test for the quantification of human immunodeficiency virus type 1 (HIV-1) RNA in human EDTA plasma using the automated GeneXpert Systems.

Intended Use: For use as an aid in clinical management of patients infected with HIV-1.
Xpert HIV-1 Viral Load XC is intended for use in conjunction with clinical presentation and
other laboratory markers for disease prognosis and for use as an aid in assessing viral
response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels
from HIV-1 infected individuals. Xpert HIV-1 Viral Load XC is intended to be performed by trained professional users or trained healthcare workers in laboratory or near-patient testing environments. Xpert HIV-1 Viral Load XC is not intended to be used as a donor screening test for HIV-1 infection.

Technical specifications:
·Dedicated single-use testing cartridges to use with item S0004191 GeneXpert IV,10C with starter kit-laptop or with item S0004192 GeneXpert IV,10C with starter kit-desktop.
·Single-use disposable cartridges that contain the RT-PCR reagents and carry out the sample extraction and RT-PCR processes minimizing cross-contamination.
·Sample type, and volume: Plasma, 1mL. Validated with K2 EDTA, and PPT-EDTA.
·Clinical Sensitivity for the detection of virological failure at 1000 copies/mL: 94.5%
·Clinical Specificity for the detection of virological failure at 1000 copies/mL: 98.3%
·Invalid rate: 3.9%
·Specificity among HIV-negative individuals: 100%
·Limit of Detection (LOD): 4.9 copies/mL.

Manufacture product reference:
GXHIV-VL-XC-CE-10 (Cepheid)

QMS/Regulatory Requirements
·CE IVD
·ISO 13845:2016.
·WHO Prequalified product.

Items supplied with:
10 x Xpert HIV-1 Viral Load XC Cartridges with Integrated Reaction Tubes.
10 x Disposable 1 mL transfer pipettes. (1 bag of 10 /kit.)
CD (1 per kit).
IFU.

Items required, but not supplied:
·GeneXpert Dx System, GeneXpert Infinity System or GeneXpert Edge System catalogue number varies by configuration): GeneXpert instrument, computer with proprietary GeneXpert Software Version 4.7b (GeneXpert Dx System), Xpert 6.4b or higher (Infinity System), GeneXpert Edge Software Version 1.0 (GeneXpert Edge System), 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.

Shelf life upon manufacture:
18 months.

Storage and transportation:
Store the HIV-1 VL XC test cartridges at 2 to 28 °C.

Weight and Volume:
Estimated weight: 0.8 Kg.
Estimated volume: 0.011 dm3.

General recommendations:
Follow strictly manufacturer instructions for use.

Useful links.
WHO-PQ Public report Xpert HIV-1 VL XC