GeneXpert IV, HIV1 VL cartridge kit/10

General description:
Xpert HIV-1 VL assay is an in vitro reverse transcriptase polymerase chain reaction (RT PCR) assay for the detection and quantification of Human Immunodeficiency Virus type 1 (HIV-1) RNA in human plasma from HIV-1 infected individuals, using the automated GeneXpert Instrument Systems. The Xpert HIV-1 VL assay is validated for quantification of RNA from HIV-1 Group M, Group N, and Group O.

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
- The cartridge self-contained with small inlet for sample introduction and single use reducing and eliminating potential sample cross-contamination.
- Sample volume for analysis: 1mL plasma in EDTA, EDTA-PPT or ACD coagulant
- Performance characteristics:
Sensitivity for virological failure at 1000 copies/ml: 94.14%
Specificity for virological failure at 1000 copies/ml: 98.50%
Invalid rate: 2.94%

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

Items supplied with:
10 x Xpert HIV-1 Viral Load cartridges with integrated reaction tubes
10 x Disposable 1 mL transfer pipettes
1 x CD ( Includes IFU)

Items required, but not supplied:
- GeneXpert Dx System or GeneXpert Infinity System (catalogue number varies by configuration): GeneXpert instrument, computer with proprietary GeneXpert Software Version 4.7b, Xpertise 6.4b or higher, barcode scanner, and operator manual.
- Bleach, 70% Ethanol, disposable gloves, EDTA specimen tubes, EDTA plasma preparation tubes, ACD specimen tubes, printer, Centrifuge for processing serum and plasma specimens

Shelf life:
18 months from the date of manufacturing; do not use beyond its expiry date.

Storage and transportation:
The test kit (Xpert HIV-1 Viral Load cartridges) should be stored at 2–28 °C. Protect against humidity and direct sunlight.

General recommendations:
Follow strictly manufacturer instructions of the test procedure (especially adherence to reading time)
Do not substitute reagents from other kits/batches

Weight and Volume:
Estimated weight: 0.8Kg
Estimated volume: 0.011cdm