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SYPHILIS RPR TEST, carbon test, ser/pl, 1test (ARL. 900100)

https://medicalguidelines.msf.org/en/node/299
https://unicat.msf.org/cat/product/80340
STD SSDTSYPT100T2

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).
18
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
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.
0208
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)
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
SC subscriptions: included in supply or field tools

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SYPHILIS RPR TEST (Arlington)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 25 or 100.

Definition

Qualitative or semi-quantitative non-treponema agglutination test on card using a VDRL (Veneral Disease Research Laboratory) antigen combined with carbon particles.

Used for the screening and the follow-up of syphilis in human serum or plasma.

Remark

Compared with the RPR test, the syphilis RDT (see related articles below) has two practical advantages:​

  • 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

Synonym

RPR = Rapid Plasma Reagin

Specifications

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Components

  • RPR Test cards (10-well) (3 or 10)
  • RPR Carbon antigen (0.5ml or 2.0ml)
  • Reactive control (0.5ml or 2.0ml)
  • Weak reactive control (0.5ml or 2.0ml)
  • Non reactive control (0.5ml or 2.0ml)
  • 3 ml Dropping bottle and 20G needle
  • Disposable stirrer pipets (25 or 100)

Technical specifications

  • Sample type: serum or plasma (EDTA)
  • Sample volume: at least 0,5 ml

Packaging & Labelling

Kit of 25 or 100 tests

Instructions for use

Follow the instructions.

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

The reagent may contain dangerous products (see the leaflet of the manufacturer).

Storage

  • Keep refrigerated between 2 and 8ºC
  • Do not freeze
  • Shelf life: 18 mois
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of total shelf life
  • Not to be used beyond expiry date

(Cf Introduction: Thermosensitive products)

Waste management

Incinerate the cards and the used materials.

MSF requirements

Inexpensive.

Quantitative and qualitative methods are possible.

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