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Disease/health condition - Neglected tropical diseases, Visceral leishmaniasis (Kala-azar)
Antibodies to recombinant K39 (rK39) antigen
Setting:
1. Non-laboratory
Tiered Testing Service:
Primary health care center without laboratory District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Lateral flow RDT
Information History
First added in 2019
Changed in 2024
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of clinically suspected visceral leishmaniasis (Kala-azar).
Specimen types
Capillary whole blood
WHO prequalified or recommended products
N/A
GMDN

62907

Multiple Leishmania species antigen IVD, kit, rapid ICT, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple species of the parasitic protozoan Leishmania in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method* . This is a rapid test used in the laboratory or in point-of-care analyses typically as an aid in the diagnosis of cutaneous leishmaniasis. It is not intended to be used for self-testing.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
* lateral flow test
EMDN

W0105050205

LEISHMANIA

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
WHO Expert Committee on the Control of the Leishmaniases & World Health Organization. (‎2010)‎. Control of the leishmaniases: report of a meeting of the WHO Expert Commitee on the Control of Leishmaniases, Geneva, 22-26 March 2010. World Health Organization. https://iris.who.int/handle/10665/44412 ; Comité de Expertos de la OMS sobre el Control de las Leishmaniasis & Organización Mundial de la Salud. (‎2012)‎. Control de las leishmaniasis: informe de una reunión del Comité de Expertos de la OMS sobre el Control de las Leishmaniasis, Ginebra, 22 a 26 de marzo de 2010. Organización Mundial de la Salud. https://iris.who.int/handle/10665/82766
Technical specifications
N/A
SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte and the availability of WHO guidelines and technical reports, including recommendations for the use of this test. The selection of disease specific tests for the EDL also took into account relevant priority diseases for WHO such as NCDs including DM, CVD and cancer, HIV infection, malaria, NTDs, STIs, tuberculosis, viral hepatitis B and C, among others.
N/A
The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
N/A