Xpert HIV-1 Qual XC EID, kit/10

General description:
Xpert HIV-1 Qual XC (Extended Coverage) is an in vitro nucleic acid amplification test for the qualitative detection of human immunodeficiency virus type 1 (HIV-1) total nucleic acids, on the automated GeneXpert System. The test is used to detect HIV-1 in human dried blood spots (DBS) and EDTA capillary or venous whole blood (WB) specimens from individuals suspected of HIV-1 infection. Xpert HIV-1 Qual XC is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other laboratory markers in infant, adolescent and adult populations. Xpert HIV-1 Qual XC is intended to be used by laboratory professionals, trained health care professionals or other health care workers receiving appropriate training on the use of the device. This test may be used in laboratory or near-patient testing environments.

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.
Performance characteristics:
·Sensitivity (Infants <18months) (DBS) – 96.6%
·Specificity (Infants <18months) (DBS) – 100%
·Sensitivity Adults (DBS) – 95%
·Sensitivity Adults (WB) – 100%
·Specificity Adults (DBS) – 100%
·Specificity Adults (WB) – 100%

Manufacture product reference:
Cepheid AB, Sweden. GXHIV-QA-XC-CE-10 (Regulatory version: CE Marked)

Items supplied with:
·10 x Xpert HIV-1 Qual XC Cartridges with Integrated Reaction Tubes
·10 x Disposable 100uL transfer pipettes
·1 x CD (Includes IFU)

Items required but not provided:
•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), Xpertise 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
•Newly prepared 10% bleach/sodium hypochlorite
•Ethanol or denatured ethanol
•If using DBS:
oDBS filter paper cards for 12 mm spots, e.g., Whatman 903, Munktell or equivalent
oLancets, desiccants, plastic sealable bags
oTweezers/forceps (straight, metal, blunt-tipped, kept sterile with bleach/sodium hypochlorite
oScissors, sterile (Only needed if not using a perforated DBS card to excise DBS from filter paper)
oServiette/Wipe
oAntiseptic
•If using capillary blood:
oLancets, Serviette/Wipe
oAntiseptic
Shelf life:
18 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. Protect 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.
·Do not use a cartridge if it appears wet or if the lid seal appears to have been broken.
·Do not use a cartridge that has been dropped after removing it from the packaging.
·Wear protective disposable gloves, laboratory coats and eye protection when handling specimens and reagents. Wash hands thoroughly after handling specimens and test reagents.
·Please refer to the current version of the manufacturer’s instructions for use.