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TEST HIV1+2/SYPHILIS, ser/pl/wb, 1test (First Resp.I20FRC25)

https://medicalguidelines.msf.org/en/node/299
https://unicat.msf.org/cat/product/85182
STD SSDTHISY25T

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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).
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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HIV1+2/SYPHILIS TEST (First Response)

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 (IgM and IgG) and T. pallidum in human whole blood, serum or plasma and capillary blood.

Specifications

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Components

  • 25 x test devices with desiccant in individual foil pouches
  • 25 x specimen transfer device
  • 1 x assay diluent (2.5 ml vial)
  • 25 x lancets
  • 25 x alcohol swabs
  • 1 instructions for use

Technical specifications

  • Sample type: whole blood, serum, plasma
  • Technology: rapid immunochromatographic assay
  • Format: lateral flow cassette, 25 tests
  • Sample type: serum, plasma, whole blood (venous or capillary)
  • Sample volume: 20µl
  • Time to result: 15-25 minutes
  • Performance according to WHO PQ report (February 2020);
    • HIV: Sensitivity 100% (98.2-100), Specificity 99.5% (97.2-100)
    • Syphilis: Sensitivity 99% (96.4-99.9), Specificity 100% (98.2-100)

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 4 - 30°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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