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HIV 1 + 2 TEST (STAT-PAK), ser/pl/wb, 1 test, HIV101

https://medicalguidelines.msf.org/en/node/289
https://unicat.msf.org/cat/product/19088
STD SSDTHIVS20T

Valid Article

Former Code(s): DDGTHIVS20T
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.
1525
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 (STAT-PAK)

CAUTION

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

Controls are to be ordered separately (cold chain)!

Definition

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

Specifications

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Components

  • 20 indivdually pouched test devices
  • 1 vial of running buffer
  • 20 disposable 5 µl sample loops
  • 1 product insert

Technical specifications

  • 3 steps rapid test (10 minutes)
  • Sample type: serum, plasma and whole blood (venous and capillary)
  • Sample volume: 5 µl
  • Antigen; HIV-1 and HIV-2
  • According to the "WHO Prequalification of Diagnostics Programme Public report" (2012), performance evaluation on a panel of 1079 biological specimens showed
    • Sensitivity 99.52% (98.3% - 100%)
    • Specificity 100% (99.4% - 100%)

Packaging & Labelling

Kit of 20 tests

Control: box of 3 vials of 0.25 ml

To be Ordered Separately

Control solutions

Instructions for use

Follow instructions on the package insert.

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

TEST DEVICE

  • Store between 8 and 30ºC
  • Do not freeze
  • Shelf life: 24 months
  • Not to be used beyond expiry date

CONTROL

  • Keep refrigerated between 2 and 8°C
  • Do not freeze

(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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