Last Updated: 29/10/2025
Validation of diagnostics to identify glucose-6-phosphate dehydrogenase (G6PD) activity in the US
Objectives
To assess the accuracy of a point-of-care (POC) G6PD test as compared to a reference assay in detecting G6PD activity.
G6PD status is particularly relevant for the treatment and prevention of malaria. Malaria is prevented and treated using a variety of treatments, some of which pose a high risk to those with G6PD deficiency. The 8-aminoquinoline– based drugs for malaria treatment and prophylaxis, such as primaquine and tafenoquine, are the only ones with the capacity to prevent relapse and eliminate the liver stage parasites in Plasmodium vivax infections. Because of the risks associated to G6PD deficiency for primaquine exposure, WHO recommends that “the G6PD status of patients should be used to guide administration of primaquine for preventing relapse”.
Given variety of clinical settings where G6PD status can be used to inform clinical care, point-of-care (POC) G6PD tests are required to support broader availability of primaquine and, in the future, tafenoquine. For treatment of women whose enzymatic activity is estimated to be normal by qualitative testing but is still too low for treatment of high-dose primaquine or tafenoquine, a quantitative portable device will be needed to obtain more accurate levels of G6PD activity to ensure appropriate and safe treatment.
ClinicalTrials.gov ID: NCT04010695
May 2019 — Aug 2019
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