What is this project?
This project supports development of advanced malaria diagnostic technologies that can benefit from early access to field sites for first rapid targeted feasibility and validation testing. Within the context of the project, we perform a prospective performance evaluation study of novel malaria diagnostic tools that have the potential to address the technical and operational limitations of current malaria rapid diagnostic tests (RDTs), particularly in view of:
- the emergence of falciparum parasites with hrp2/3 deletions
- the need for improved tools to identify all Plasmodium species
- the need for improved surveillance
Why are we working on it?
The 2030 Agenda for Sustainable Development Goals (SDG) has reignited public health interest to meet eradication targets for malaria. In striving for this goal, it is critical that all commodities, including point-of-care diagnostics which are pivotal to control and eliminate malaria, deliver optimal performances. Today, clinical case management in malaria-endemic countries heavily rely on the use of histidine-rich protein 2 (HRP2)-based RDTs; however, the gradual spread of hrp2/hrp3-deleted mutants in several endemic countries in South America, Asia, and Africa is now threatening the utility and impact of these RDTs.
A pressing need for innovative malaria diagnostics to identify all Plasmodium species including hrp2/3-deleted P. falciparum parasites and to improve malaria surveillance is, therefore, well-recognized. To support and accelerate development of the emerging new tools, it is of paramount importance that test developers have access to clinical samples obtained from real-life settings so that they can push diagnostic prototypes forward and turn a good idea into a design-locked and later regulatory-approved test.
What does it involve?
In November 2019, FIND launched a “Call for Innovation” with the distinct aim to identify novel and promising malaria innovations for inclusion in FIND-sponsored evaluation studies in malaria-endemic settings. We received a total of 24 submissions for this call, which we carefully reviewed and sorted according to six criteria:
– technology readiness level (TRL5 or higher)
– intended use case
– availability of prototypes at study start
– availability of basic performance data
– suitability to site capacity
– predicted acceptability to use in high burden countries
A total of seven novel technologies under development were selected for the in-country evaluation study:
|OmniVis||Purdue /OmniVis||US||A LAMP-based, handheld smartphone-enabled device|
|Improved pLDH-based tests||Access Bio||US||pLDH-based lateral flow assays with improved sensitivity|
|Gazelle||Hemex Health||US||A rapid malaria test based on haemozoin detection|
|Malaria Screener||NLM NIH||US||A smartphone application for automated parasite detection & counting|
|miLab||Noul||South Korea||An all-in-one automated microscopy solution from sample preparation to AI analysis and data network|
|Improved pLDH-based tests||Mologic||UK||pLDH-based lateral flow assays with improved sensitivity|
|Scanwell RDT Reader App||Scanwell Health||US||Smartphone-enabled RDT reader|
FIND has now established a study platform in Indonesia, Peru, Rwanda, and Sudan in collaboration with Eijkman Institute for Molecular Biology, Universidad Peruana Cayetano Heredia, University of Gitwe, and Institute of Endemic Diseases, respectively. The first patient was recruited in the study on October 10, 2020 in Sudan. The results of the study are expected in Q2 2021.
What do we expect to achieve?
This project will generate valuable data on the performance of novel malaria diagnostic tests in comparison to the performance of microscopy, the commonly used method for malaria diagnosis, and inform test developers and the global health community about the technical and operational assay optimization requirements for an accelerated market access of these tools.
What is the timescale?
These activities are expected to run for 2 years, between 2019 and 2021.
Partners and funding
Field activities are conducted in partnership with Eijkman Institute for Molecular Biology, Universidad Peruana Cayetano Heredia, University of Gitwe, and Institute of Endemic Diseases. This project is supported by the Australian government.
For more information please contact us.