(mb GeneXpert) TEST HIV-1 Qual EID, cartridge GXHIV-QA-CE-10
Outdated Article
(mb GeneXpert) TEST HIV-1 Qual EID, cartridge
This article has been replaced by ELAEMBIT125. The new cartridge has improved coverage.
CAUTION
This test (= 1 cartridge) is worded and codified by unit to make the order easier, but it is always packaged in kit of 10.
Definition
The Xpert HIV-1 Qual assay, performed on the GeneXpert. It is cartridge based and is a qualitative in vitro diagnostic test designed to detect HIV-1 total nucleic acids using human whole blood and dried blood spots.
The Xpert HIV-1 Qual assay is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other laboratory markers.
The assay is not intended to be used as a donor screening test for HIV-1.
Specifications
Technical specifications
The Xpert® HIV-1 Qual (GXHIV-QA-CE-10) contains sufficient reagents for 10 specimens.
Each kit contains following:
- 10 HIV Qual (GXHIV-QA-CE-10) assay cartridges with integrated reaction tubes
- Bead 1, bead 2, bead 3 (freeze dried): 1 of each per cartridge
- Lysis reagent (Guanidium Thiocyanate): 1.4ml per cartridge
- Rinse reagent: 0.5ml per cartridge
- Elution reagent: 2.5ml per cartridge
- Binding reagent: 2.4ml per cartridge
- Proteinase K reagent: 0.48ml per cartridge
Clear, colorless liquid reagents
- 10 disposable 1 ml transfer pipettes
- 1 CD containing the package insert
Quality control
Each test includes a Sample Volume Adequacy (SVA) control, a Sample Processing Control (SPC) and a Probe Check Control (PCC).
External controls, not available in the kit, should be used in accordance with Ministry of Health requirements as applicable.
Packaging & Labelling
1 kit = 10 tests
To be Ordered Separately
The Eppendorf ThermoMixer C and Smartblock need to be ordered for DBS application only (see related articles).
Instructions for use
Follow the instructions for use
Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.
https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx
For offline access, contact your laboratory advisor.
Precautions for Use
- Do not open a cartridge until you are ready to perform testing
- Do not use the 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.
- Do not shake the cartridge. Shaking or dropping the cartridge after opening the cartridge lid may yield invalid results.
- Do not use any reagents that have become cloudy or discolored.
- Do not use a cartridge that has leaked.
Storage
- Store between 2 and 28°C
- Shelf life: 24 months
- Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
Waste management
The cartridge contains guanidium thiocyanate as the lysis reagent. This chemical is highly toxic and all care should be taken when using the cartridges in case of spills etc.
Please note that as this chemical is also highly toxic to aquatic life, it should optimally be disposed of by incineration. No liquids from the cartridge should be released into the environment.
Classification EC Regulation N° 1272/2008
Acute toxicity oral, 5
H302 | Harmful if swallowed |
H320 | Causes eye irritation |
H313 | May be harmful in contact with skin |