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TRYPANOSOMA gambiense TEST (CATT), reagent, wb, 1 test

https://medicalguidelines.msf.org/en/node/259
https://unicat.msf.org/cat/product/19110
STD SSDTTRYT2RT

Valid Article

Former Code(s): DDGTTRYT2RT
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).
12
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
W010505 - Parasitology (infect. immunology/nat)
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.
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)
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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TRYPANOSOMA gambiense TEST (CATT) reagent

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 250.

Definition

Reagent for the direct agglutination test allowing rapid detection of antibodies to Trypanosoma brucei gambiense in blood.

Used for the screening of Trypanosoma gambiense trypanosomiasis (sleeping sickness). Does not detect Trypanosoma rhodesiense.

Synonym

CATT test = Card Agglutination Test for Trypanosomiasis, Testtryp CATT

Specifications

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Components

Reagents box for 250 tests including:

  • CATT-antigen: 5 bottles, freeze-dried solution of fixed and stained trypanosomes, 2.5ml/bottle
  • Positive control: 1 bottle of freeze-dried goat antiserum, 0.5ml
  • Negative control: 1 bottle of freeze-dried bovine albumin, 0.5ml
  • CATT buffer : 1 bottle of buffer for reconstituting the CATT reagent and controls, 30ml

Technical specifications

  • Qualitative or quantitative test
  • Sensitivity: 98% on whole blood
  • Specificity: 74% on whole blood

Packaging & Labelling

Kit of 250 tests

Instructions for use

Follow the instructions in the leaflet.

Can be performed on whole blood.

The reagent kit and the accessories kit are sold separately, but both of them are essential for performing the test. Although they are not submitted to the same transport regulations, they must be ordered together.

Controls and reagents must be imperatively reconstituted by the corresponding buffer solution. Never split the components of a reagent kit, nor use together components of different reagent kits.

This is a screening test which must be confirmed by other examinations of CSF, blood (CTC: direct detection of parasites in the blood) or ganglionar punction before treatment.

This test needs a rotator (see related articles below) and a stand for capillary tubes to be ordered separately or manufactured locally.

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

  • Keep refrigerated between 2º and 8ºC
  • Do not freeze
  • Shelf life: 12 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life
  • Not to be used beyond expiry date
  • Once reconstituted, can be kept for maximum one week

(Cf Introduction: Thermosensitive products)

MSF requirements

Easy to perform for mass screening.

Good sensitivity.

Can be performed as qualitative or quantitative method.

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