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HIV 1 + 2 TEST, ser/pl/wb, 1 test (Determine HIV-1/2 7D2343)

https://medicalguidelines.msf.org/en/node/289
https://unicat.msf.org/cat/product/19086
STD SSDTHIVD10T

Valid Article

Former Code(s): DDGTHIVD1T-
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).
18
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
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.
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)

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HIV 1 + 2 TEST (Determine)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 100.

Definition

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

Specifications

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Technical specifications

  • Reagent strips attached by 10 (stripable)
  • One-step rapid test (15 minutes)
  • Sample type: serum, plasma or venous blood (or capillary blood)
  • Sample volume: 50 µl
  • Antigen: recombinant proteins and synthetic peptides
  • Performance according to the WHO Prequalification report (version January 2020):
    • Sensitivity: 100% (99.1% - 100%)
    • Specificity: 98.93% (97.8% - 99.6%)

Packaging & Labelling

Aluminium pouch with zip closure of 100 tests (= 10 cards)

Instructions for use

Follow the instructions in the leaflet.

Provide an automatic pipette or disposable pipettes (MiniPets) and corresponding tips for the application of the 50 µl sample (see related articles below).

For serum or plasma samples

  • No additional reagent is required
  • For plasma samples, use EDTA tubes

For whole blood samples

  • Chase buffer is mandatory, ref. 7D2243 or 7D2243R(must be ordered separately, see related articles below)
  • For venous samples, use EDTA tubes
  • For capillary samples, use EDTA capillary tubes, ref. 7D2227 (must be ordered separately, see related articles below)

The absence of positive and negative external controls requires to perform a control on a known blood, fresh or kept in good conditions (2 - 8ºC).

Within the MSF pretransfusional protocol, it is recommended to collect a single blood sample in a tube with anticoagulant, EDTA, in order to perform all the necessary tests (blood group determination, screening for hepatitis, HIV, syphilis and malaria).

CAUTION: As any HIV test used alone, this test has no diagnostic value. It should be confirmed by a second rapid test.

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: 18 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life
  • 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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