Indication - Malaria
Plasmodium spp. antigens; species-specific (e.g. HRP2) and/or pan-species specific (e.g. pan-pLDH)
Facility level:
Assay formats
Status history
First added in 2018
Changed in 2020
Purpose type
To diagnose 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
WHO supporting documents
WHO guidelines for the treatment of malaria, third edition (2015) https://apps.who.int/iris/handle/10665/162441 Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 8 (2016–2018) https://apps.who.int/iris/handle/10665/276190 WHO good practices for selecting and procuring rapid diagnostic tests for malaria (2011) https://apps.who.int/iris/handle/10665/44530; Information note on recommended selection criteria for procurement of malaria rapid diagnostic tests https://apps.who.int/iris/handle/10665/259870; https://www.who.int/health-topics/malaria#tab=tab_1
ICD11 code: 1F45

Summary of SAGE IVD recommendation

The selection of the disease specific diagnostics tests for the EDL took into account the relevant priority diseases for the WHO such as HIV infection, tuberculosis, malaria, viral hepatitis B and C, syphilis and HPV infection. For these diseases there are WHO guidelines and technical reports, including recommendations for the appropriate IVDs. These documents are the result of significant evidence review and formed the basis for the inclusion of these IVDs in the EDL.

Details of submission from 2020

The inclusion of this entry was based on WHO guidelines and technical reports that include recommendations for the appropriate IVDs.