The prequalification of this G6PD diagnostic test marks a significant milestone in facilitating safe and effective P. vivax malaria treatment, reaffirming WHO’s dedication to ensuring equitable access to life-saving health solutions globally. Some 500 000 people die each year from malaria, most of them children.
This package of actions by WHO reflects the organization’s recent adoption of synchronized and parallel processes for two key functions: developing recommendations for essential health products and overseeing their prequalification.
P. vivax malaria is endemic in all WHO Regions except the European Region, with an estimated 9.2 million clinical cases occurring in 2023. P. vivax is the dominant malaria parasite in most countries outside of sub-Saharan Africa.
“The prequalification of this G6PD enzyme test for patients with P. vivax malaria can help countries in enhancing access to much-needed quality-assured tests, enabling safe and effective treatment and prevention of this type of relapsing malaria,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “Currently, no other prequalification applications are received for this type of tests. We encourage the submission of additional products to expand the range of effective diagnostic tools available to countries in need.”
Testing devices that can accurately distinguish patients with G6PD activity levels above and below the normal levels provide critical information to clinicians to decide which of P. vivax anti-relapse treatment regimens is most appropriate, including low- and high-dose primaquine and single-dose tafenoquine.
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