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

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.