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Disease/health condition - Malaria
Plasmodium spp.
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory Blood establishment laboratory
Assay format
Microscopic examination
Information History
First added in 2018
Changed in 2024
Purpose type
Diagnosis, Monitoring
Purpose
To diagnose infection by one or more human malaria parasite species (P. falciparum, P. vivax, P. malariae, P. ovale) and to monitor response to treatment. To screen blood donations for one or more human malaria species (P. falciparum, P. vivax, P. malariae, P. ovale) in endemic areas. To selectively screen blood donations from individuals identified to be at risk of transmitting malaria (travellers or previous residents of endemic countries).
Specimen types
Capillary whole blood, Venous whole blood
WHO prequalified or recommended products
N/A
GMDN

43587

Biological stain IVD

A chemical agent(s), dye(s) and/or solution(s) intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

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

W0104050102

PARASITOLOGY STAINS

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 ; World Health Organization. (‎2010)‎. Basic malaria microscopy, 2nd ed. World Health Organization. https://iris.who.int/handle/10665/44208 ; The Portuguese version is published by PAHO (‎Part 1)‎: https://iris.paho.org/handle/10665.2/52941 ; The Portuguese version is published by PAHO (‎Part 2)‎: https://iris.paho.org/handle/10665.2/52944 ;
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