SWITZERLAND—The World Health Organization (WHO) has recently prequalified the first diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency, a major step in ensuring the safe delivery of treatments for Plasmodium vivax (P. vivax) malaria.
This new test is crucial for administering WHO-recommended therapies to prevent the relapse of this common malaria strain.
This announcement follows another significant achievement by the WHO—just weeks earlier, the organization granted prequalification to the Xpert® MTB/RIF Ultra, a molecular diagnostic test for tuberculosis (TB).
Both tests meet WHO’s high standards for safety, quality, and performance, ensuring the reliability and effectiveness of the diagnostic tools used in global health efforts.
The pre-qualification of the G6PD test is a critical milestone in the global fight against P. vivax malaria, as it allows for the safe use of anti-relapse treatments, such as tafenoquine.
Without proper testing for G6PD deficiency, which affects over 500 million people globally, it has been difficult to provide these treatments safely.
If not properly managed, this deficiency can cause serious side effects, including the destruction of red blood cells.
WHO’s recent moves highlight its growing commitment to improving health equity worldwide.
The G6PD test was prequalified just after the approval of two new tafenoquine products, which are part of updated WHO malaria guidelines aimed at preventing relapses of P. vivax malaria.
Together, these actions demonstrate the WHO’s new approach to simultaneously developing essential health product recommendations and ensuring their prequalification, streamlining the process and reducing the time it takes to make life-saving treatments available in low- and middle-income countries.
- vivax malaria remains widespread, with an estimated 9.2 million cases reported in 2023, and it is particularly common outside sub-Saharan Africa.
Accurate G6PD tests are available in laboratory and field settings, providing healthcare workers with critical information to select the most appropriate treatment.
These tests distinguish between normal and low G6PD activity levels, enabling the safe use of drugs like primaquine and tafenoquine.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, emphasized that the G6PD test prequalification will help countries ensure access to high-quality tests, leading to safer and more effective malaria treatments.
Dr. Nakatani also called for more diagnostic tools to expand the options available to countries struggling with malaria.
Dr. Daniel Ngamije Madandi, Director of WHO’s Global Malaria Programme, added that the wider availability of the test would strengthen the global response to malaria, reducing P. vivax relapses and, ultimately, transmission.
The STANDARD G6PD System, developed by SD Biosensor, is a key tool in this effort, providing near-patient, semi-quantitative testing that delivers results in minutes, even in non-laboratory settings.
This breakthrough marks an important step in WHO’s ongoing efforts to improve health outcomes worldwide.
Sign up HERE to receive our email newsletters with the latest news and insights from Africa and around the world, and follow us on our WhatsApp channel for updates.
