(mb GeneXpert) TEST HIV-1 VL, cartridge, GXHIV-VL-CE-10
Valid Article
OC subscriptions: included in supply or field order tools (e.g. UniField)
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SC subscriptions: included in supply or field tools
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OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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(mb GeneXpert) TEST HIV-1 VL, cartridge
This cartridge will be phased out by December 2024 by the manufacturer and will be replaced by a new cartridge: GXHIV-VL-XC-CE-10
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 Viral Load assay runs on the GeneXpert System. It is a cartridge based test and allows measurement of HIV-1 RNA concentration (or viral load) in plasma. Assessment of the viral load levels is a strong predictor of the HIV disease progression.
The Xpert® HIV-1 Viral Load assay includes RNA extraction, purification, reverse transcription and cDNA quantitation (by real-time PCR) and provides results in 90 minutes.
Specifications
Technical specifications
The Xpert® HIV-1 Viral Load (GXHIV-VL-CE-10) contains sufficient reagents for 10 specimens.
Each kit contains the following:
- 10 HIV VL assay cartridges (GXHIV-VL-CE-10) with integrated reaction tubes per cartridge:
- Bead 1, bead 2, bead 3 (freeze dried): 1 of each
- Lysis reagent (Guanidium Thiocyanate): 2.0ml
- Rinse reagent: 0.5ml
- Elution reagent: 1.5ml
- Binding reagent: 2.4ml
- Proteinase K reagent: 0.48ml
Beads are solid white components in cartridges; reagents are clear liquids which are primarily buffered in aqueous solutions.
- 10 disposable 1 ml transfer pipettes
- 1 CD containing the package insert
Quality control
Each test includes a Sample Volume Adequacy (SVA) control, Internal Quantitative Standard High and Low (IQS-H and IQS-L) which is also 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
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
- Manipulation and transport practices : do not spill to avoid leaking
- Do not open a cartridge until you are ready to perform testing
- Use the cartridge within 4 hours after opening the cartridge lid
- Do not use a cartridge that has leaked
Storage
- Store between 2 and 28°C
- Shelf life: 18 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.
Lysis reagent contains guanidium thiocyanate
Acute toxicity oral, 5
| H302 | Harmful if swallowed |
| H320 | Causes eye irritation |
| H313 | May be harmful in contact with skin |