HIV 1+2, TEST, ser/pl/wb, 1 test (First Resp v2.0 PI05FRC25)
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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HIV 1 + 2 TEST (First Response), version 2.0
CAUTION
This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 25.
Definition
Specifications
Quality Standards Comment
WHO prequalified
Components
- Test device pouch containing: 1 test device, 1 desiccant,:25x
- Specimen transfer device: 25x
- Assay buffer bottle (2.5ml): 1x
- Sterile lancets: 25x
- Alcohol swabs: 25x
- IFU: 1x
Technical specifications
- Rapid test, lateral flow, 2 steps
- Antigen: recombinant HIV antigen
- Sample type: whole blood (capillary or venous blood), serum, plasma
- Sample volume: 20µl (whole blood), 10µl (serum or plasma)
- Time to result: 15 minutes
- Performance of detection of HIV-1 according to the WHO Prequalification report (version 4.0 September 2025):
- Sensitivity: 100% (99.2-100%)
- Specificity: 100% (99.5-100%)
- Performance of HIV-2: not evaluated
Packaging & Labelling
Kit of 25 tests
Instructions for use
Although this test includes a separate line for HIV-2, it is not validated by MSF for testing HIV-2 and is therefore not suitable for differentiating between HIV-1 and HIV-2 infections.
Follow the instructions in the leaflet.
Can be performed on serum, plasma or whole blood.
Provide an automatic pipette or disposable pipettes (MiniPets) and corresponding tips for the application of the 10 µl serum/plasma sample (see related articles below).
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
All biological samples must be considered as potentially infectious and handled with the usual precautions (compulsary wearing of gloves, hand washing, etc.).
Storage
- Between 4°C - 30°C, Protect from sunlight - Protect from humidity
- Do not freeze reagents
- Shelflife: 24 months
- Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life
- Not to be used beyond expiry date
Waste management
Incinerate the tests and the used materials.
MSF requirements
No need for cold chain.
NB: Different tests for HIV screening are proposed in this catalogue. To decide which one to choose, please refer to your laboratory advisor.
Any replacement of RDT in MSF HIV testing algorithms in a project should always be made in consultation with OCs laboratory advisors. Recommendation must consider multiple technical factors, be context-specific and remain flexible to adapt to field realities.