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HIV 1+2 TEST, ser/pl/wb, 1test (Bioline HIV ½ 3.0 03FK16)

https://medicalguidelines.msf.org/en/node/289
https://unicat.msf.org/cat/product/19084
STD SSDTHIVB25T

Valid Article

Former Code(s): DDGTHIVB25T
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.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
CT30
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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)

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HIV 1 + 2 TEST (Bioline HIV-1/2)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 25 or 30.

Definition

Rapid immunochromatographic test for the qualitative detection of antibodies to HIV-1 including subtype O and HIV-2.

Specifications

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Components

Ref 03FK10

  • 30 test devices
  • 1 vial of diluent
  • NO accessories for sampling (to be ordered seperately)

Ref 03FK16

  • 25 test devices
  • 1 vial of diluent
  • 25 plastic capillary tubes of 20 µl without anticoagulant
  • 25 lancets
  • 25 alcohol swabs

Technical specifications

  • Two-step rapid test (15 minutes)
  • Antigen: recombinant protein
  • Sample type: serum, plasma and whole blood (venous and capillary)
  • Sample volume: 10µl serum/plasma or 20µl whole blood
  • Performance according to the WHO Prequalification report (version August 2020):
    • Sensitivity: 100% (99.2% - 100%)
    • Specificity: 99.9% (99.2% - 100%)

Packaging & Labelling

Kit of 25 or 30 tests

Instructions for use

Not suitable for the differentiation of 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.

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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 and 30ºC
  • Do not freeze
  • Shelf life: 24 months
  • Not to be used beyond expiry date

(Cf Introduction: Thermosensitive products)

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.

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