GeneXpert HIV1 Qual EID cartridge kit/10

General description:
Xpert HIV-1 Qual assay, performed on the GeneXpert Instrument Systems, is a qualitative in vitro diagnostic test designed to detect Human Immunodeficiency Virus Type 1 (HIV-1) total nucleic acids on the automated GeneXpert Systems using human whole blood (WB) and dried blood spot (DBS) specimens from individuals suspected of HIV-1 infection and is validated for specimens across 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 and 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 infants (WB): 98.69%
Specificity infants (WB): 100%
Sensitivity infants (DBS): 99.34%
Specificity infants (DBS): 100%
Sensitivity adults (WB): 96.00%
Specificity adults (WB): 100.00%
Invalid rate: 2.2%

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

Items supplied with:
10 x Xpert HIV-1 Qual Assay cartridges with integrated reaction tubes
10 x Disposable 1mL transfer pipettes
10 x HIV-1 Qual Assay Sample Reagent Set
10 x Disposable 100 μL Transfer Micropipettes
1 x CD (Includes IFU)

Items required, but not supplied:
- GeneXpert Dx System or GeneXpert Infinity Systems (catalogue 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.
- If using DBS: Whatman 903 or Munktell filter paper cards, lancets, desiccants, plastic sealable bags, and alcohol swabs, wipes, bleach, scissor, forceps, ThermoMixer C, SmartBlock

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

Storage and transportation:
Store the HIV-1 Qual assay cartridges and reagents at 2–28 °C. Protected against humidity and direct sunlight.

Weight and Volume:
Estimated weight: 0.8kg
Estimated volume: 0.011dm3

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