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Disease/health condition - Malaria
Semi-quantitative Glucose-6-phosphate dehydrogenase (G6PD)
Setting:
1. Non-laboratory
Tiered Testing Service:
Primary health care center without laboratory District hospital with laboratory
Assay format
Point-of-care test
Information History
First added in 2018
Changed in 2024
Purpose type
Aid to diagnosis
Purpose
To aid in the detection of G6PD deficiency in children (≥ 2 years) and adults. To determine G6PD activity levels (deficient, intermediate and normal) and to inform administration of specific treatment regimens (8-aminoquinoline drugs such as primaquine or tafenoquine) to prevent relapses in male and female patients with confirmed P. vivax or P. ovale malaria.
Specimen types
Capillary whole blood
WHO prequalified or recommended products
GMDN

63124

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, rapid colorimetric, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of glucose-6-phosphate dehydrogenase (G6PD) enzyme activity of red cells within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to aid in the diagnosis of G6PD deficiency. 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
EMDN

W01010199

ENZYMES - OTHER

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 guidelines for malaria, 30 November 2024. Geneva: World Health Organization; 2024. https://doi.org/10.2471/B09146
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