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Disease/health condition - Malaria
Plasmodium spp. antigens
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 2018
Changed in 2024
Purpose type
Diagnosis
Purpose
To diagnose infection by one or more human malaria parasite species (P. falciparum, P. vivax, P. malariae, P. ovale).
Specimen types
Capillary whole blood, Venous whole blood
WHO prequalified or recommended products
GMDN

52311

Multiple Plasmodium 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 Plasmodium, the malaria parasites (e.g., P. falciparum, P. vivax, P. ovale, P. knowlesi, P. malariae), 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. 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

W0105090401

PLASMODIUM (MALARIA) - RT & POC

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
World Health Organization. (‎2024)‎. WHO guidelines for malaria, 30 November 2024. World Health Organization. https://doi.org/10.2471/B09146 ; World Health Organization. (‎2011)‎. Universal access to malaria diagnostic testing: an operational manual. World Health Organization. https://iris.who.int/handle/10665/44657 ; Organisation mondiale de la Santé. (‎2012)‎. Accès universel aux tests diagnostiques du paludisme : manuel pratique. Organisation mondiale de la Santé. https://iris.who.int/handle/10665/78877
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