LSE Principal Investigator: Lesong Conteh
Start Date: 01 December 2019
End Date: 30 November 2023
Countries: Ethiopia, Sudan, Namibia, Kenya and Burkina Faso
Keywords: Malaria, diagnostic test, sub-Sahara Africa, development
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.
DIAGMAL is a collaborative research project which aims to evaluate a novel molecular diagnostic test for malaria. It 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
- is controlled via a mobile telephone
This diagnostic test circumvents complicated DNA extraction methods and has a simple read-out system that enables near patient implementation. 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.
The team at LSE will be responsible for the Health Economics outputs. An economic evaluation will be conducted to identify the incremental costs and benefits to the health care providers of introducing and routinely using mini-dbPCR-NALFIA for P.falciparum detection compared to microscopy.
The performance of the new diagnostic tool, in terms of sensitivity and specificity assessed by the clinical study, will be combined with costs to the health system (this will include costs associated with the introduction, roll-out and scale-up ofmini-dbPCR-NALFIA) to estimate the cost-effectiveness of the novel malaria diagnostic tool.
Potential costs, barriers and facilitators associated with the implementation of mini-dbPCR-NALFIA will be identified from both the supply and demand side.
The project is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP) for a period of 4 years, starting 1 December 2019.