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LEISHMANIASIS Kala Azar TEST (GAD IT LEISH) ser/wb,1t 710124

https://medicalguidelines.msf.org/en/node/261
https://unicat.msf.org/cat/product/93332
NST SSDTLEIS24T2

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).
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 (GAD IT LEISH)

This item replaces SSDTLEIS24T since september 2023; not yet validated as MSF standard, but can be considered for purchase as non standard. Please contact your laboratory referent for more information.

CAUTION

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

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 to 15 minutes on serum)

Packaging & Labelling

Kit of 24 tests

Instructions for use

Follow the instructions in the leaflet.

Can be performed on serumor 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
  • Not to be used beyond expiry date

(Cf Introduction: Thermosensitive products)

Waste management

Substance with hazardous characteristics. Please contact your watsan referent for advice on proper disposal.

Detailed hazard and precautionary information can be found in the safety data sheet (SDS).

Signal Word

Danger

Image Image
H319Causes serious eye irritation
H412Harmful to aquatic life with long lasting effects
H360DFMay damage fertility. May damage the unborn child
P201Obtain special instructions before use.
P273Avoid release to the environment
P280Wear protective gloves/protective clothing/eye protection/face protection
P305 + P351 + P338IF IN EYES: rinse cautiously with water for several minutes. If the victim wears contact lenses, remove them if possible. Keep rinsing
P308 + P313IF exposed or concerned: Get medical advice/attention.
P337 + P313If eye irritation persists: get medical advice/attention
P501Dispose of contents/container to location in accordance with local and regional/ national/ international regulations

MSF requirements

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

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