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HIV 1 + 2 TEST (Uni-Gold), ser/pl/wb, 1 test 1206502

https://medicalguidelines.msf.org/en/node/289
https://unicat.msf.org/cat/product/19090
STD SSDTHIVU20T

Valid Article

Former Code(s): DDGTHIVU20T
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.
CT25
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 (Uni-Gold)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 20.

Definition

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

Specifications

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Components

  • 20 test devices
  • 1 wash reagent: 2 ml dropper bottle
  • 20 single use pipettes

Technical specifications

  • Rapid test (± 10 minutes)
  • Antigen: recombinant protein
  • Sample type: serum, plasma and venous blood
  • Sample volume: 2 drops (approx. 60µl)
  • Performance according to the WHO Prequalification report (version April 2021):
    • Sensitivity: 99.76% (98.7%-100%)
    • Specificity: 99.85% (99.2%-100%)

Packaging & Labelling

Kit of 20 tests

Instructions for use

Follow the instructions in the leaflet: read the test result between 10 min and 12 min maximum.

Can be performed on serum, plasma or whole blood.

For whole blood capillary samples, use the pipettes included in the kit.

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 (compulsory wearing of gloves, hand washing, etc.).

Storage

  • Store between 2 and 27ºC
  • Sensitive to accumulation of exposure to high temperatures
  • 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

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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