Sensitivity of rapid diagnostic tests for malaria caused by P. falciparum and prevalence of histidine-rich protein gene deletion as cause of failure in several African countries | AFRi-MECA

Cooperating countries: Malawi and Austria

Coordinating institution: Medical University of Vienna

Project coordinator: Felix Lötsch

Partner institution: Kamuzu Central Hospital, Lilongwe

Project duration: 01.02.2024 - 31.01.2026

Project summary

The World Health Organization (WHO) estimated 241 million cases of malaria and 627 000 deaths attributable to malaria worldwide in 2020. Of these, 92% were reported from the African region. The gold standard for the diagnosis of malaria remains blood microscopy, as it provides unequivocal parasitological confirmation and species identification to ensure appropriate treatment. In recent years, systemic challenges with microscopy (time consuming, requiring training and electricity) led to the primary use of rapid diagnostic tests (RDTs) in many areas. RDTs are based on immunological detection of parasite antigens in the blood, such as LDH, aldolase or histidine-rich protein, and have the advantage of not requiring extensive training of the user or electricity.

Due to the dominance of Plasmodium falciparum in sub-Saharan Africa and its stability in high environmental temperatures, the predominant molecular target of the 419 million RDTs sold is the histidine-rich protein 2. In the previous years, Plasmodium falciparum histidine-rich protein (PfHRP) 2/3 deletions were confirmed in many countries around the world such as Brazil, the Democratic Republic of the Congo, Djibouti, Ethiopia, Ghana, the Sudan, Uganda and the United Republic of Tanzania, leading to false negative RDT results with potentially fatal consequences for the patient. Additionally, diagnosis of travel-related cases of malaria to non-endemic areas is often based on rapid diagnostic tests as skills for microscopy are lacking.

In summary, this study will provide important data on the current usefulness of RDTs both in endemic and non-endemic settings, and substantially contribute to patient safety by improving diagnostic standard operating procedures.