LEISHMANIASIS Kala Azar TEST (DAT), freeze-dried, ser/wb,5ml

STD SSDTLEID5AG

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Former Code(s): DDGTDATT5AG
W0105050205 - Leishmania
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.
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LEISHMANIASIS Kala Azar TEST (DAT)

Definition

Freeze-dried solution containing the visceral leishmaniasis antigen (Kala Azar). Essential reagent for the DAT test (Direct Agglutination Test).

The antigen used is a trypsin treated promastigote obtained from Leishmania donovani, preserved in formalin, and stained with Coomassie blue (non infectious part).

The DAT is used as a second test, to retest the samples that test negative with IT LEISH RDT. It has a higher sensitivity so this test will detect false negatives.

Specifications

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Technical specifications

  • Sensitivity: 95%
  • Specificity: 95-99%
  • Freeze-dried antigen
  • Parasite density: 5 x 107/ml

Packaging & Labelling

5 ml vial for 8 patients with 11 levels of dilution or for 12 patients with 8 levels of dilution.

Instructions for use

Follow the protocol provided with the test.

Can be performed on serum or whole blood.

Positive and negative controls have to be ordered separately (see related articles below).

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.).

Storage

  • Store between 20º and 35ºC, in a dark place
  • Shelf life: 24 months
  • Once reconstituted, the solution should be kept refrigerated between 2º and 8ºC for 7 days max.
  • Not to be used beyond expiry date

(Cf Introduction: Thermosensitive products)

Waste management

Incinerate the tests and the used materials.

MSF requirements

Only antigen validated by the Institutes of Tropical Medicine (Antwerp and Amsterdam).

Freeze-dried antigen, stable and easy to use.

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