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


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Former Code(s): DDGTSYPT30T DDGTMISC30T-
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.
The order of this product needs to be justified and is only acceptable under certain conditions.
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 (Bioline Syphilis 3.0)


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


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.


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


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  • 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
  • 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.

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.).


  • Store between 2º - 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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