(mb GeneXpert) TEST HIV-1 VL XC, cart., GXHIV-VL-XC-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 XC, cart., GXHIV-VL-XC-CE-10
This cartridge is the replacement of ELAEMBIT105, it is the new version with improved performance. It is under WHO PQ review.
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 HIV-1 VL XC test uses real-time reverse transcription polymerase chain reaction (RT-PCR) technology to achieve high sensitivity for the quantitative detection of HIV-1 RNA in human plasma from HIV-1 infected individuals.
HIV-1 Group M: A-D, F-H, J,K, CRFA/B, CRF-A/E, CRF-A/G, CRF-BC, CRF06 Group O, Group N and Group P
Specifications
Technical specifications
- Each kit is composed of:
- HIV-1 VL XC Cartridges with Integrated Reaction Tubes (10). Each cartridge contains:
- Bead 1, Bead 2, and Bead 3 (freeze-dried) 1 of each
- Lysis Reagent (Guanidinium Thiocyanate) 2.0 mL
- Rinse Reagent 0.5 mL
- Elution Reagent 1.5 mL
- Binding Reagent 2.4 mL
- Proteinase K Reagent 0.48 mL
- Disposable 1 mL Transfer Pipettes 10 per kit
- CD 1 per kit
- Assay Definition File (ADF)
- Instructions to import ADF into GeneXpert software
- Instructions for Use (Package Insert)
- Beads are solid white component in cartridge; reagents are clear liquids which are primarily buffered in aqueous solutions
Quality control
Each test includes a Sample Volume Adequacy (SVA) control, Internal Quantitative Standard High and Low (IQS-H and IQS-L), Lot Specific Parameters (LSP), 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
- GeneXpert Dx system
- Bleach or sodium hypochlorite
- Ethanol or denaturated ethanol
Instructions for use
Follow the instructions for use
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.
Classification EC Regulation N° 1272/2008
Acute toxicity Oral, 5
Signal Word
Warning
| H302 | Harmful if swallowed |
| H320 | Causes eye irritation |
| H313 | May be harmful in contact with skin |
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