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HIV 1/2 TEST ORAQUICK (Orasure) oral fl.,1self-test,5X4-1001

https://medicalguidelines.msf.org/en/node/289
https://unicat.msf.org/cat/product/71524
STD SSDTHIVO250T

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.
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 ORAQUICK (Orasure) oral fluid Self-test

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 250.

Definition

The OraQuick HIV 1/2 Self-Test is a single-use qualitative immunoassay used for self-testing for Human Immunodeficiency Virus Type 1 and 2 in oral fluid specimens.

Specifications

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Components

Each kit contains

  • 250 single pouches with:
    • a single use test device
    • a dissecant
    • a developer solution vial
  • 1 test stand
  • 1 instruction for use

Technical specifications

  • Self test
  • Sample type: oral fluid
  • Time to result: 20 min

Instructions for use

The OraQuick HIV Self-Test kit instructions for use must be followed carefully to get an accurate result.

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

  • Use with oral fluid only. The test is not for use with blood, serum, breast milk, plasma, semen, urine, vaginal fluid or sweat.
  • Do not eat or drink 15 minutes before starting testing
  • Do not use mouth cleaning products (such as mouth wash) 30 minutes before starting the test.
  • Remove dental products such as dentures or any other products that cover your gums prior the oral fluid collection
  • Do not use the test if you are on HIV treatment (ARVs) as false results may occur.
  • The test may not detect HIV infections that have occurred within 3 months of a risk event. If the test is negative, re-test 3 months after the risk event.

MSF requirements

To be used for HIV 1/2 Self-testing following the WHO HIV self testing guidelines

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