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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.
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)
https://unicat.msf.org/web/image/product.template/569623/image_1920?unique=b626a3a

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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

Contains Sodium azide (0.2% - test; 0.09% - controls)

HIV STAT-PAK test:

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

HIV Control solutions:

  • 1 vial of HIV-1 reactive control
  • 1 vial of HIV-2 reactive control
  • 1 vial of non reactive control

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

Transport Dangerous Goods

Transport not regulated

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.

Classification EC Regulation N° 1272/2008

  • Test :
    • Acute toxicity, oral, category 4
  • ​Controls : not classified as hazardous

Signal Word

Test: Warning

Image
H302Harmful if swallowed
H315Causes skin irritation
H317May cause an allergic skin reaction
H319Causes serious eye irritation
H332Harmful if inhaled.
H334May cause allergy or asthma symptoms or breathing difficulties if inhaled.
H412Harmful to aquatic life with long lasting effects
EUH032Contact with acids liberates very toxic gas.
EUH208supplied by the manufacturer. Comply with the safety instructions. Contains (name of sensitising substance). May produce an allergic reaction. Contains (name of sensitising substance). May produce an allergic reaction.
P261Avoid breathing dust/fume/gas/mist/vapours/spray.
P262Do not get in eyes, on skin, or on clothing.
P273Avoid release to the environment
P280Wear protective gloves/protective clothing/eye protection/face protection
P391Collect spillage
P332 + P313If skin irritation occurs: get medical advice/attention
P342 + P311If experiencing respiratory symptoms: Call a POISON CENTER or

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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