“This project is part of the EDCTP2 programme supported by the European Union"

PROJECT

Malaria

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. falciparum malaria 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.



FOTO 1: Mothers with their children waiting for malaria diagnosis

For more information on malaria check the fact sheet of the World Health Organization:
https://www.who.int/news-room/fact-sheets/detail/malaria

Need for new malaria diagnostics

Rapid diagnostic test (RDTs) have become cornerstone for the management of malaria in many endemic settings. However, the use of RDTs in diagnostic strategies is jeopardised due to persistent malaria proteins after successful treatment, leading to false positive test results. Furthermore, studies have reported false positive diagnosis by RDTs particularly in seasonal malaria transmission settings or under harsh environmental conditions. Moreover, increasing numbers of false negative test results are reported from malaria endemic regions due to deletions in the DNA of the malaria parasite. In general, all malaria RDTs 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.



FOTO 2: Performing Malaria Diagnosis in the field

A new malaria diagnostic

This DIAGMAL project aims to assess the diagnostic accuracy of a miniaturized molecular diagnostic test for malaria in five different malaria endemic settings. The innovative diagnostic platform 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.

Cost benefit studies

Too often, new diagnostic approaches are proposed without properly addressing the costs associated with their implementation and studying the acceptability of patients and health staff. Therefore, we will perform a cost effectiveness study towards the implementation of the diagnostic platform in the different endemic settings. Furthermore, social science and health system research will seek evidence of how the new diagnostic can be most successfully implemented within local socio-economic and cultural contexts and in real life conditions.



FOTO 3: Study staff interviewing people

Route to Market

The consortium, by including partners who are well positioned in the RDT market with ample expertise in diagnostic product manufacturing and registration, wants to develop a product dossier that can be used for registration purposes (CE mark), and meets prequalification of diagnostics requirements of the WHO. In order to ensure the uptake of the mini-db-PCR-NALFIA by the diagnostic market, the consortium will explore business opportunities within the diagnostic market.