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HIV 1+2 TEST, ser/pl/wb, 1 test (ONE STEP ITPW02232-TC40)

https://medicalguidelines.msf.org/en/node/289
https://unicat.msf.org/cat/product/98192
NST SSDTHIVI40T2

Valid Article

Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
W0105090302 - Hiv 1 / 2 - rt & poc
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
CT30
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
https://www.unicat.msf.org/web/image/product.template/589150/image_1920?unique=9004431

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HIV 1+2, Intec ONE STEP

CAUTION

The test is worded and codified by unit to make the order easier, but it is always packaged in kit of 40 tests

Definition

Rapid immunochromatographic test for the qualitative detection of antibodies to HIV-1 and HIV-2 in human whole blood, serum and plasma.

Specifications

Narrow cassette with less plastic and more environmentally friendly

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Quality Standards Comment

WHO prequalified

Components

  • Test cassette: 40 pieces
  • Dropper: 40 pieces
  • Sample diluent: 4 bottles x 2 ml
  • Sterile safety lancets 21G: 40 pieces
  • Alcohol swab: 40 pieces
  • Package insert 1 piece

Technical specifications

  • Rapid test, lateral flow, 2 steps
  • Antigen: recombinant HIV antigen
  • Sample type: capillary or venous whole blood, serum or plasma
  • Sample volume: 30 µl
  • Time to result: 15 to 20 minutes
  • HIV-1 detection performance according to the WHO Prequalification report (version 5.0 May 2025):
    • Sensitivity: 100% (99.2-100%)
    • Specificity: 100% (99.5-100%)
  • HIV-2 detection performance: not evaluated

Packaging & Labelling

Kit of 40 tests

Transport Dangerous Goods

Transport not regulated

Instructions for use

Follow the instructions in the leaflet.

Can be performed on serum, plasma or whole blood.

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

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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

  • Store between 2°C and 30°C Protect from sunlight - Protect from humidity
  • Shelflife: 24 months
  • Sample diluent should be used into 8 weeks after opening.
  • Not to be used beyond expiry date
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life

(Cf Introduction: Thermosensitive products)

Waste management

Incinerate the tests and the used materials.

Classification EC Regulation N° 1272/2008

Not classified as hazardous

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.

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Validated by OCA laboratory referent, Erwan Piriou (November 2025)