Phase 3 evaluation of an innovative simple molecular test for the diagnosis of malaria in different endemic and health settings in sub-Sahara Africa (DIAGMAL)

Malaria is a severe disease caused by Plasmodium parasites. The parasites are spread to people through the bites of infected female Anopheles mosquitoes, called “malaria vectors.” There are 5 parasite species that cause malaria in humans, and 2 of these species – P. falciparum and P. vivax – pose the greatest threat.

Malaria is an acute febrile illness. In a non-immune individual, symptoms usually appear within 2 weeks after the infective mosquito bite. The first symptoms – fever, headache, and chills – may be mild and difficult to recognize as malaria; there is often confusion with the common flu. If not treated within 24 hours, P. falciparummalaria can progress to severe illness, often leading to death.

There are more than 400,000 deaths per year due to malaria. Over 200 million cases of malaria are recorded each year, and probably this number is an underestimation. The main victims of this disease are young children and pregnant women, many of them living in sub-Sahara Africa.Rapid Diagnostic Tests (RDTs) have become the cornerstone for the management of malaria in many endemic settings. However, the use of RDTs in diagnostic strategies is jeopardized due to persistent HRP2 antigen after successful treatment, leading to false-positive test results. Furthermore, studies have reported false-positive diagnosis by PfHRP2-RDTs particularly in seasonal malaria transmission settings or under harsh environmental conditions. Moreover, increasing numbers of false-negative PfHRP2 results are reported from malaria-endemic regions due to hrp2 deletions. In general, all malaria RDTs (pLDH- and HRP2-based) have limited sensitivity, often resulting in false-negative tests. This is particularly evident in near malaria elimination settings. Consequently, there is a pressing need to develop and evaluate more sensitive and accurate diagnostic tests that circumvent the above-mentioned limitations of RDTs.

The innovative diagnostic platform (miniaturized molecular diagnostic test) does not require DNA extraction, has a simple read-out system, can be battery operated, can be used as point-of-care and is controlled via a mobile telephone. This makes this test well suited for implementation in resource-limited settings, which is often the reality in many malaria endemic countries. The test is in late stage of development and has passed phase 1/2 diagnostic evaluations. Diagnostic accuracy will be assessed through a phase 3 diagnostic trial conducted in Ethiopia, Sudan, Namibia, Kenya and Burkina Faso.

EDCTP GrantsDIAGMAL project website

Diagnostics

Dec 2019 — Nov 2024

$3.19M

Burkina Faso
Ethiopia
Kenya
Namibia
Sudan
The Netherlands
United Kingdom