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

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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).
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)
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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 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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