WHO Prequalifies First G6PD Diagnostic Test

By Crystal Lubbe

January 9, 2025

The World Health Organization’s (WHO) prequalification of the first diagnostic test for glucose-6-phosphate dehydrogenase (G6PD) deficiency is a milestone that has significant implications both globally and specifically for Africa. The G6PD diagnostic test will enhance the safety of malaria treatment, streamline access to health products, and help in reducing the incidence of malaria relapses.

Global Impact

1. Enhanced Safety in Malaria Treatment:

The prequalification of the G6PD diagnostic test is crucial for safely administering treatments for _Plasmodium vivax_ (P. vivax) malaria. G6PD deficiency, a genetic condition affecting over 500 million people, leads to acute hemolysis (destruction of red blood cells) when specific malaria treatments are used. By using the G6PD diagnostic test, clinicians can determine appropriate treatment regimens, such as low- or high-dose primaquine or single-dose tafenoquine. This approach significantly reduces the risk of adverse reactions and improves patient outcomes.

2. Streamlined Access to Health Products:

The WHO’s new approach of synchronising the development of recommendations for essential health products with their prequalification processes aims to reduce the time it takes to bring vital health products, like the G6PD diagnostic test, to low- and lower-middle-income countries. This streamlined approach will enhance global health equity by expediting access to life-saving products.

3. Reducing Malaria Relapses:

P. vivax malaria is endemic in all WHO regions except Europe, with an estimated 9.2 million clinical cases in 2023. The availability of the G6PD diagnostic test will aid in reducing the number of P. vivax infections due to relapse, thereby decreasing onward transmission of the disease. This is particularly vital in areas where P. vivax is the dominant malaria parasite.

Impact on Africa

1. Specific Endemic Context:
Although P. vivax is not the primary malaria parasite in sub-Saharan Africa (where _Plasmodium falciparum_ is more prevalent), it still poses a significant health risk in other parts of Africa. The G6PD diagnostic test will be especially beneficial in regions like North Africa and certain areas of East Africa where P. vivax is present.

2. Addressing G6PD Deficiency:
G6PD deficiency is prevalent in many African populations. The availability of a reliable and accessible G6PD test will facilitate the identification of individuals at risk of hemolysis from certain malaria treatments, ensuring safer treatment protocols are followed. This is particularly crucial in resource-limited settings where access to healthcare can be challenging.

3. Public Health and Operational Benefits:
Integrating this diagnostic test into malaria control programs across Africa can enhance the overall effectiveness of treatment and prevention strategies. By minimising the risk of relapses and adverse reactions, health systems can better manage malaria cases, leading to improved health outcomes and reduced healthcare costs associated with malaria treatment.

In summary, the WHO’s prequalification of the G6PD diagnostic test represents a significant advance in the global fight against malaria, particularly concerning P. vivax. By enhancing the safety and efficacy of malaria treatments worldwide, including in African regions where P. vivax is present, this test contributes to the broader goal of reducing malaria-related morbidity and mortality. The introduction of the G6PD diagnostic test is pivotal in both global health and strategy implementations for improving patient care.

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