Project: Phase 3 evaluation of an innovative simple molecular test for the diagnosis of malaria in different endemic and health settings in sub-Sahara Africa
| Acronym | DIAGMAL (Reference Number: RIA2018D-2496) |
| Duration | 01/12/2019 - 30/11/2023 |
| Project Topic | RDTs have become the cornerstone for the management of malaria in many endemic settings. However, the use of RDTs in diagnostic strategies is jeopardised 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.This proposal aims to assess the diagnostic accuracy of a miniaturized molecular diagnostic test for malaria in five different endemic settings. The 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. 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 and reported according to STARD principles.Too often, new diagnostic approaches are proposed without properly addressing the costs associated with their implementation and studying the acceptability of end-users (patients and health staff). Therefore, we will perform a cost-effectiveness study towards the implementation of the diagnostic platform in different endemic settings. Furthermore, social science and health system research (mixed-method study) 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.The consortium, by including a partner who is well-positioned in the RDT market with ample expertise in diagnostic product manufacturing and registration, wants furthermore 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, in line with EDCTPs objectives for the current call, the consortium includes a partner that is specialised in creating business opportunities within the diagnostic market and can assist in the uptake of the diagnostic platform by interested companies. |
| Network | EDCTP2 |
| Call | Diagnostic tools for poverty-related diseases |
Project partner
| Number | Name | Role | Country |
|---|---|---|---|
| 1 | Academisch Medisch Centrum bij de Universiteit van Amsterdam | Coordinator | Netherlands |
| 3 | Addis Ababa University | Partner | Ethiopia |
| 4 | Amref Health Africa | Partner | Kenya |
| 5 | Blue Nile National Institute for Communicable Disease , University of Gezira | Partner | South Sudan |
| 6 | Centre National de la Recherche Scientifique et Technologique - Institut de Recherche en Science de la Santé | Partner | Burkina Faso |
| 7 | Forsite Diagnostics Limited | Partner | United Kingdom |
| 8 | Innova Partnerships Ltd | Partner | United Kingdom |
| 9 | London School of Economics and Political Science | Partner | United Kingdom |
| 10 | University of Namibia | Partner | Namibia, Republic of |