Malaria parasites are hiding in the liver, undetectable by standard blood tests, and a new rapid diagnostic aims to flush them out. The problem is *Plasmodium vivax*, a malaria species that can lie dormant in the liver for months or years, reactivating to cause repeated illness and sustain transmission. Current diagnostics only spot active blood-stage infections, missing these silent carriers. This project will turn a validated laboratory test into a simple, point-of-care rapid diagnostic test (RDT) — similar to a pregnancy test — that detects antibodies to four proteins that signal the presence of dormant liver-stage parasites. If successful, the RDT will enable a new control strategy called PvSeroTAT: test people for past exposure to dormant parasites, then treat those who test positive to clear the hidden reservoir. The consortium will manufacture the test in Senegal, validate it on banked and fresh blood samples in Ethiopia and Madagascar, and pursue regulatory approval. This could transform malaria elimination efforts in sub-Saharan Africa and beyond, giving health workers a practical tool to interrupt a transmission cycle that conventional diagnostics cannot touch.
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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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