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TEST HIV1+2/SYPHILIS, ser/pl/wb, 1test (Standard Q 09HIV20D)

https://medicalguidelines.msf.org/en/node/299
https://unicat.msf.org/cat/product/86517
STD SSDTHISY25T3

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).
S
The order of this product needs to be justified and is only acceptable under certain conditions.
CT3+
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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HIV1+2/SYPHILIS TEST (Standard Q)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 25

Definition

A qualitative screening in vitro diagnostic test for detection of antibodies of HIV type 1 & 2 and T. pallidum in human whole blood, serum or plasma and capillary blood.

Specifications

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Components

  • 25 x test device (individually in a foil pouch with desiccant)
  • 1 x buffer Bottle 4ml
  • 25 x capillary tube (20μl)
  • 1 x instructions for use
  • 25 x sterile lancets
  • 25 x alcohol swabs

Technical specifications

  • Sample type: serum, plasma, whole blood (venous or capillary)
  • Rapid immunochromatographic assay
  • Format: lateral flow cassette, 25 tests
  • Sample volume: 20µl (whole blood), 10µl (serum or plasma)
  • Time to result: 15-20 minutes
  • Performance according to WHO PQ report, May 2020;
    • HIV: Sensitivity 100 (98.2-100), Specificity 99.5 (97.2-100)
    • Syphilis: Sensitivity 95.5 (91.6-97.9), Specificity 99.5 (97.2-100)

To be Ordered Separately

  • Micropipette and tip
  • Blood collection tube
  • PPE (Personal Protective Equipment)
  • Biohazard container
  • Timer

Instructions for use

Follow the instructions in the leaflet.

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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Storage

  • Between 2 - 40°C, Protect from sunlight - Protect from humidity
  • Do not freeze reagents
  • Shelflife: 24 months

Waste management

Incinerate the tests and the used materials.

MSF requirements

For specific programs only, please refer to your laboratory advisor.

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