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A point-of-care serological rapid diagnostic test for risk of Plasmodium vivax hypnozoite infection (PvSeroRDT)

Project description

A point-of-care rapid diagnostic test against malaria in Africa

Plasmodium vivax is the most challenging human malaria parasite to eliminate, as conventional diagnostics often fail to detect individuals with dormant liver forms. The consortium has developed the first diagnostic test to target these dormant forms. The EU-funded PvSeroRDT project aims to create a point-of-care (POC) rapid diagnostic test (RDT) for P. vivax to support the Serological Test and Treatment (PvSeroTAT) malaria control strategy. Using lateral flow technology, the POC RDT will measure antibodies to four P. vivax proteins, indicating the parasite’s dormant liver stage. The test will be validated using bio-banked samples and field trials in Ethiopia and Madagascar. It aligns with the World Health Organization’s diagnostic preferences and aims to support malaria elimination efforts.

Objective

Plasmodium vivax is considered the most difficult species of human malaria parasite to eliminate because of the inability of conventional diagnostics to detect individuals who carry dormant liver forms and sustain malaria transmission. The consortium has developed the first diagnostic test that addresses this problem. PvSeroRDT aims to develop a point-of-care (POC) rapid diagnostic test (RDT) to transfer the consortium’s validated lab-based test to the field to support implementation of the P. vivax Serological Test and Treatment (PvSeroTAT) malaria control strategy.

The PvSeroRDT specific objectives are:
1) Develop a POC RDT using lateral flow technology to measure antibodies to four P. vivax proteins that are biomarkers for the dormant liver-stage of P. vivax.
2) Establish Africa-based manufacturing capacity at DIATROPIX (Senegal) following RDT development at Abingdon Health, a UK-based SME specialising in lateral flow assays.
3) Validate RDT performance with bio-banked samples, followed by field-based clinical validation on freshly collected samples in Ethiopia and Madagascar.
4) Develop a clear regulatory strategy to streamline market authorization and access to this first-in-class P. vivax serological testing.

PvSeroRDT addresses all expected outcomes and impacts of this call topic and work program, respectively. Specifically, it will contribute a robust POC diagnostic to the pipeline in sub-Saharan Africa (SSA) and enable the implementation of the AU-EU Innovation Agenda for public health. The project is designed to address the WHO’s preferred profile for P. vivax diagnosis, to translate an SME prototype to Africa-based industrial design, and to test clinical performance in several SSA sites, thus enhancing international cooperation in SSA and improving training opportunities in SSA. Ultimately, PvSeroRDT will facilitate implementation of PvSeroTAT – a new intervention for malaria elimination.

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HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

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Call for proposal

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(opens in new window) HORIZON-JU-GH-EDCTP3-2023-02-two-stage

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Coordinator

INSTITUT PASTEUR
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 2 012 596,85
Address
RUE DU DOCTEUR ROUX 25-28
75724 Paris
France

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Ile-de-France Ile-de-France Hauts-de-Seine
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 2 012 596,85

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