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SYPHILIS TEST, ser/pl/wb, 1 test (First response PI08FRC25)

https://medicalguidelines.msf.org/en/node/299
https://unicat.msf.org/cat/product/83734
STD SSDTSYPT25T3

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).
W0105090105 - Syphilis - 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.
S
The order of this product needs to be justified and is only acceptable under certain conditions.
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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SYPHILIS TEST (FIRST RESPONSE)
Image

CAUTION

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

Definition

Rapid immunochromatographic test for the qualitative detection of anti-treponemal antibodies.

Used for the screening of syphilis in blood donors and pregnant women.

Remark

The syphilis RDT has two practical advantages compared with the RPR syphilis test:

  • it can be performed on whole blood, serum or plasma
  • it does not require cold chain

but it doesn't allow the follow-up after treatment

Specifications

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Quality Standards Comment

Included in the WHO Model List of Essential In Vitro Diagnostics 2019

Components

  • 25 x test devices with desiccant in foil pouch
  • 25 x specimen transfer device
  • 1 assay buffer bottle (1x 2.5ml)
  • 25 x lancets
  • 25 x alcohol swabs
  • 1 instructions for use

Technical specifications

  • Single device
  • Two-step rapid test (20-25 minutes)
  • Sample type: serum/plasma/whole blood (venous or capillary)
  • Sample volume: 20µl
  • According to the WHO PQ report, January 2021:
    • Sensitivity on serum/plasma: 99.6% (98.0-100)
    • Specificity on serum/plasma: 94.9% (98.4-100)

Packaging & Labelling

Box of 25 tests

Instructions for use

Follow the instructions in the leaflet.

Can be performed on serum, plasma or whole blood.

Within the MSF pretransfusional protocol, it is recommended to collect a single blood sample in a tube with anticoagulant, EDTA if possible, in order to perform all the necessary tests (blood group determination, screening for hepatitis, HIV, syphilis and malaria).

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 (compulsory wearing of gloves, hand washing, etc.).

Storage

  • Store between 2 - 30º C
  • Do not freeze
  • Shelf life: 24 months
  • Not to be used beyond expiry date

(Cf Introduction: Thermosensitive products)

Waste management

Incinerate the tests and the used materials.

MSF requirements

Two - step rapid test.

No need for cold chain.

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