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Disease/health condition - Malaria
Plasmodium spp. antigens
Setting:
2. Laboratory
Tiered Testing Service:
Blood establishment laboratory
Assay format
Immunoassay
Information History
First added in 2020
Purpose type
Screening
Purpose
To screen blood donations for one or more human malaria species (P. falciparum, P. vivax, P. malariae, P. ovale) in endemic areas.
Specimen types
Serum, Plasma
WHO prequalified or recommended products
N/A
GMDN

64436

Multiple Plasmodium species antigen IVD, kit, enzyme immunoassay (EIA)

A collection of reagents and other associated materials intended to be used for the qualitative and/or 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 using an enzyme immunoassay (EIA) method.

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
EMDN

W0105050209

PLASMODIUM (MALARIA)

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. (‎2009)‎. Screening donated blood for transfusion-transmissible infections : recommendations. World Health Organization. https://iris.who.int/handle/10665/44202
Technical specifications
N/A
Related Medical Devices in MeDevIS
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