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LEISHMANIASIS VISCERAL TEST (InBios), ser, 1test, INS025

https://medicalguidelines.msf.org/en/node/261
https://unicat.msf.org/cat/product/76438
NST SSDTLEIS25T

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.
W01050904 - Parasitology 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.
P
The order of this product needs to be justified and is only acceptable under certain conditions.
1525
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)
https://unicat.msf.org/web/image/product.template/588365/image_1920?unique=dd23fb1

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LEISHMANIASIS VISCERAL TEST (InBios)

CAUTION

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

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.

Specifications

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Components

  • 25 Individually pouched test strips or 25 test strips in a vial with dessicant in the cap
  • One vial of chase buffer solution

Technical specifications

  • Specimen: serum
  • Volume: 20 µl
  • Time to result: 10 minutes
  • Chase buffer: colourless liquid
  • Performance varies depending of geographic zone (Kalazar Detect showed sensibility and specificity significantly different depending of geographic zone, as described in RDT multicentric evaluation WHO 2011 : https://www.who.int/publications/i/item/9789241502238)

Packaging & Labelling

Kit of 25 tests

Transport Dangerous Goods

Transport not regulated

Instructions for use

  • Follow the instructions in the leaflet
  • Can be performed on serum
  • It is not recommended to use this test with capillary blood as it reduces significatively the performances
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Precautions for Use

All biological samples must be considered as potentially infectious and handled with the usual precautions (compulsory wearing of gloves, hand washing, etc.).

Storage

  • Store between 20 and 30ºC
  • Do not freeze
  • Shelf life: 24 months
  • Not to be used beyond expiry date

Waste management

Incinerate the tests and the used materials.

Classification EC Regulation N° 1272/2008

Not classified as hazardous

MSF requirements

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

Donation received from WHO (manufacturer InBios) for the emergency stock Leishmaniasis of WHO.

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Validated by Laurence Flevaud - OCBA Laboratory referent. July 2025