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SYPHILIS TEST, ser/pl/wb,1 test(Bioline Syphilis 3.0 06FK10)

https://medicalguidelines.msf.org/en/node/299
https://unicat.msf.org/cat/product/19106
STD SSDTSYPT30T

Valid Article

Former Code(s): DDGTSYPT30T
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).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
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.
P
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.
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)

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SYPHILIS TEST (Bioline Syphilis 3.0)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 30.

Definition

Rapid immunochromatographic test for the qualitative detection of anti-treponemal antibodies (IgG, IgM, IgA).

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

Remark

This syphilis rapid test 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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Components

  • 30 x Test devices with desiccant in individual foil pouches
  • 1 x Assay diluent (1 x 4ml/vial)
  • 30 x 20μl capillary pipettes
  • 30 x Lancets
  • 30 x alcohol swabs
  • 1 Instructions for use

Technical specifications

  • Sample type: serum, plasma, whole blood (venous or capillary)
  • Sample volume: 10µl serum/plasma or 20µl whole blood
  • Time to result: 5-20 minutes
  • Antigens: TpN15, TpN17, TpN47
  • According to the study "Diagnostics Evaluation Series N°1. SDI Report. The Sexually Transmitted Diseases Diagnostics Initiative (SDI)", WHO/TDR, 2003:
    • Sensitivity on serum/plasma: 95 %
    • Specificity on serum/plasma: 94.9 %

Packaging & Labelling

Kit of 30 tests

Instructions for use

Follow the instructions in the leaflet.

Can be performed on serum, plasma or whole blood.

  • For whole blood samples, use a 20 µl pipette
  • For serum or plasma samples, use a 10 µl pipette (see related articles below)

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).

CAUTION: Used alone, this test has no diagnostic value. Moreover, it does not allow differentiating old syphilis from active syphilis.

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.

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 - 30ºC
  • 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

One-step rapid test.

No need for cold chain.

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