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

About

Plasmodium vivax is the most challenging human malaria parasite to eliminate, as conventional diagnostics fail to detect individuals with dormant liver forms that sustain malaria transmission. The PvSeroRDT project, funded by the Global Health EDCTP3, aims to address this challenge by developing a point-of-care (POC) rapid diagnostic test (RDT) to support P. vivax Serological Test and Treatment (PvSeroTAT) malaria control strategy.

The PvSeroRDT consortium has developed the first diagnostic test specifically targeting these dormant liver forms. The POC RDT will use lateral flow technology to measure antibodies to four P. vivax proteins, which serve as biomarkers for the parasite’s dormant stage. This novel approach will allow for the identification of individuals who have been recently infected and are likely to carry hypnozoites, enabling targeted treatment to prevent relapse infections and further transmission.

To ensure effective implementation, the project will establish Africa-based manufacturing capacity at DIATROPIX (Senegal) following initial development at Abingdon Health, a UK-based SME specializing in lateral flow assays. The test’s performance will be validated using bio-banked samples and subsequently through field-based clinical validation on freshly collected samples in Ethiopia and Madagascar.

In parallel, the project will develop a regulatory strategy to streamline market authorization and facilitate access to this first-in-class P. vivax serological testing tool. The PvSeroRDT project aligns with the World Health Organization’s diagnostic preferences and contributes to malaria elimination efforts by introducing a robust POC diagnostic tool in sub-Saharan Africa (SSA). Additionally, it supports the AU-EU Innovation Agenda for public health, enhances international cooperation, and strengthens training opportunities in SSA.

By translating an SME prototype into an Africa-based industrial design and testing clinical performance across multiple SSA sites, PvSeroRDT will ultimately facilitate the implementation of PvSeroTAT—providing a transformative intervention for malaria control and elimination.

Work Organization

The project begins with Work Packages* WP1 – Scientific Project Leadership led by Institut Pasteur de Dakar and WP2 – Project Management and Coordination led by Institut Pasteur. These two work packages set the foundation for coordination, project administration, and communication.

Once the leadership and project management frameworks are in place, the project focuses on Objective 1: RDT Development, which is the core of the project. This objective is supported by two work packages :

• WP3 – Biobanking and Reagent Coordination: This ensures timely access to key reagents (antigens and monoclonals) and bio-bank samples for clinical studies.
• WP4 – RDT Research & Development: WP4 handles the development of the RDT, from product requirements to creating validation batches.

Once the RDT is developed, the next major step is Objective 2: Local Manufacturing, which focuses on establishing manufacturing capacity in Africa. This is achieved through:

• WP5 – RDT Manufacturing: This supports the technology transfer to DIATROPIX (Senegal), manufactures validation batches, and conducts verification and stability studies to ensure product quality.

Next, the project moves to Objective 3: Clinical Validation, ensuring the RDT performs well in real-world settings. This is achieved through:

• WP6 – Clinical Validation: This evaluates the RDT’s performance using both bio-banked and freshly collected samples from field studies in Ethiopia and Madagascar.

Alongside the development and validation, the project must ensure that the RDT meets regulatory requirements. This is addressed through Objective 4: Regulatory Strategy:

• WP7 – Regulatory Adherence and Policy: This develops strategies for regulatory mapping, policy and stakeholder engagement, as well as market assessment to facilitate market authorization.

Finally, all the data collected from the RDT development, manufacturing, clinical validation, and regulatory strategy is analyzed in WP8 – Statistics and Modelling:

• This WP focuses on understanding factors affecting RDT performance, developing new classification algorithms, conducting formal statistical analysis of clinical data and and using mathematical models to extend findings beyond the clinical validation sites.

*The division of the project activities into “Work Packages” (WP) is typical in this type of large, international projects that are funded by the European Union. Each WP groups activities that help achieve a common objective and it is led by 1-2 researchers that work within the institutions that form the consortium.

Consortium

The following partners combine their expertise to develop and deploy rapid diagnostic tests for malaria, focusing on P. vivax, with a focus on clinical trials, serological surveillance, and capacity building across multiple African countries.

• Institut Pasteur de Dakar (IPD): A leading African research institute in infectious diseases, IPD focuses on vaccine and RDT production, surveillance, and public health services. The IPD team involved in PvSeroRDT leads projects on serological surveillance of malaria and other diseases. IPD co-coordinates the PvSeroRDT project. Dr Inès Vigan-Womas and Dr Makhtar Niang lead the PvSeroRDT work at IPD.
• Diagnostic Technologies (DTX): DTX is hosted within Institut Pasteur de Dakar and specializes in manufacturing diagnostics for diseases like malaria. It works closely with IPD to develop affordable and reliable RDTs. The DTX team involved in PvSeroRDT will lead manufacturing of the new RDT. Dr Cheikh Tidiane Diagne leads the PvSeroRDT work at DTX.
• Institut Pasteur (IP): IPP focuses on biomedical research and innovation especially on infectious diseases, while also working on public health and education. The IPP team involved in PvSeroRDT leads serological surveillance of malaria, focusing on P. vivax, and coordinates research on diagnostic methods and treatment. IP co-coordinates the PvSeroRDT project. Dr Michael White leads the PvSeroRDT work at IP.
• Armauer Hansen Research Institute (AHRI): AHRI undertakes medical research in a range of infectious diseases and non-communicable conditions. The AHRI team involved in PvSeroRDT conducts malaria research and clinical trials in Ethiopia, contributing to national malaria policies. For PvSeroRDT, it leads clinical trials to validate the RDT’s accuracy. Dr Fitsum Girma leads the PvSeroRDT work at AHRI.
• Institut Pasteur Madagascar (IPM): IPM pursues research in disease prevention and treatment, while also contributing to economic growth via research, education and public health activities. The team involved in PvSeroRDT specializes in malaria epidemiology and diagnostics, leading clinical trials, data collection, and biological sample analysis for PvSeroRDT. Dr Rindra Randremanana leads the PvSeroRDT work at IPM.
• Abingdon Health (AH): AH specializes in the development and manufacturing of diagnostic tests, including RDTs for infectious diseases. The AH team involved in PvSeroRDT leads the development of the new RDT for vivax malaria.
• London School of Hygiene & Tropical Medicine (LSHTM): LSHTM is a public health university with a network of specialist centres, units and partners around the world. It will bring to PvSeroRDT expertise on serological surveillance of malaria. Prof. Chris Drakeley leads the PvSeroRDT work at LSHTM.
• Foundation for Innovative New Diagnostics (FIND): FIND supports equitable access to diagnostics. For PvSeroRDT, it leads the development of the RDT’s reader, as well as the strategy for regulatory approval and policy change.
• Walter and Eliza Hall Institute (WEHI): WEHI tackles health problems in various fields, including immune health and infection. For PvSeroRDT, it contributes expertise in P. vivax sero-epidemiology and assists with the design and testing of serological diagnostics. Prof. Ivo Mueller leads the PvSeroRDT work at WEHI.

Funding

Get in touch with the coordination team at PvSeroRDT[at]pasteur.fr.