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  3. LEISHMANIASIS Kala Azar TEST (IT LEISH), ser/pl/wb,1t 710124
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LEISHMANIASIS Kala Azar TEST (IT LEISH), ser/pl/wb,1t 710124

https://medicalguidelines.msf.org/en/node/261
https://msf.oodin.sh/cat/product/19096
STD SSDTLEIS24T

Outdated Article

Former Code(s): DDGTLEIS24T
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.
15
Shelf life = length of time a product can remain active and effective. Short shelf life = shelf life = < 24 months
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.
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.
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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VISCERAL LEISHMANIASIS Kala Azar TEST (IT LEISH)

CAUTION

This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 24.

This item replaced by non-standard test SSDTLEIS24T2, for which the validation dossier is pending. Please contact your laboratory referent for more information.

Definition

Rapid immunochromatographic test using the recombinant antigen rK39 for the detection of antibodies against visceral leishmaniasis (Kala-Azar).

This test is used as a first screening test for suspected Leishmaniasis cases.

Synonym

VISCERAL LEISHMANIASIS TEST

Specifications

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Components

24 hermetically sealed pouches containing:

  • 1 device with dipstick, conjugate well, wash well
  • 1 well cover
  • 1 dropper ampoule with buffer solution
  • 1 lancet
  • 1 disinfecting swab
  • 1 pipette (printed mark for 10 µl)
  • 1 schematic test procedure

Technical specifications

Rapid test (± 20 minutes on whole blood and ± 10 minutes on serum ou plasma)

Packaging & Labelling

Kit of 24 tests

Instructions for use

Follow the instructions in the leaflet.

Can be performed on serum, plasma or whole blood (capillary or venous sample in EDTA tube).

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 2º and 30º C
  • Do not freeze
  • Shelf life: 15 months
  • Guaranteed minimum remaining shelf life at delivery: 1/3 of the total shelf life
  • Not to be used beyond expiry date

(Cf Introduction: Thermosensitive products)

Waste management

Incinerate the tests and the used materials.

MSF requirements

Screening test for detecting visceral leishmaniasis (Kala-Azar).

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