A holistic approach in patient management and epidemic surveillance through convergence of diagnostic technologies, capacity building and stakeholder engagement

Project Information

HoliCare

Grant agreement ID: 101057596

DOI

10.3030/101057596

EC signature date 14 July 2022

Start date 1 September 2022

End date 31 August 2026

Funded under

• Health

Total cost

€ 5 857 773,50

EU contribution

€ 5 857 773,50

Coordinated by

KUNGLIGA TEKNISKA HOEGSKOLAN
Sweden

Periodic Reporting for period 2 - HoliCare (A holistic approach in patient management and epidemic surveillance through convergence of diagnostic technologies, capacity building and stakeholder engagement)

Reporting period: 2024-03-01 to 2025-08-31

Summary of the context and overall objectives of the project

The HOLICARE project is redefining healthcare innovation in sub-Saharan Africa by addressing the persistent burden of poverty-related diseases (PRDs). Through a holistic approach combining technology development, capacity building, and locally led implementation, the project aims to transform diagnostic access and reliability in low-resource environments. Focusing on lower respiratory tract infections (LRTIs)—a major cause of morbidity and mortality—HOLICARE is delivering scalable diagnostic and digital solutions tailored to the realities of low- and middle-income countries (LMICs), bridging advanced European know-how with local clinical needs.
During the current reporting period, HOLICARE has achieved major milestones in developing, validating, and deploying its two-tier diagnostic strategy. The multiplexed lateral flow test (Multi-LFT) has now progressed from optimization to clinical use, with patient recruitment and data collection ongoing across all three African partner countries. In parallel, the integrated Point-of-Care (POC) instrument—combining isothermal molecular detection (LAMP) and quantitative immunoassays for pathogen and host biomarker analysis—has reached the stage of functional prototype testing. The integration of these complementary components, linked via a unified digital interface for data capture and traceability, represents a major step toward establishing an interoperable, sample-to-answer diagnostic platform for clinical management and epidemic surveillance in resource-limited settings.
In tandem, HOLICARE has built a strong foundation for high-quality clinical research through the establishment of harmonized, quality-controlled biobanks in Senegal, Uganda, and Ethiopia. These facilities are now operational and fully aligned with the clinical trial workflows, ensuring standardized sample collection, transport, and storage across sites. The biobanks not only underpin ongoing clinical validation but also constitute long-term national assets for future infectious-disease research. Complementing these efforts, the consortium has deployed a robust digital data infrastructure through a unified REDCap environment and the HOLICARE mobile application, enabling real-time, secure, and interoperable management of clinical, laboratory, and biobanking data. Together, these infrastructures are accelerating the translation of diagnostic research into actionable clinical and public-health outcomes.
Human-capacity strengthening continues to be a cornerstone of HOLICARE’s mission. Over the period, numerous workshops, training sessions, and research-exchange visits have been organised, equipping healthcare staff, laboratory technicians, and early-career researchers with practical skills in diagnostic validation, data management, and biobanking. The HOLICARE Academy webinars and on-site mentorship programmes have fostered cross-learning between African and European partners, ensuring that technical competencies and leadership remain embedded locally. This integrated approach to training and knowledge transfer ensures that the benefits of the project will outlive its funding period, reinforcing long-term regional capacity for innovation and health system resilience.
The adoption and implementation strategy of HOLICARE has advanced considerably through sustained engagement with ministries of health, regulatory authorities, and private stakeholders. Regulatory mapping and dialogue have guided the development of sustainable deployment and reimbursement pathways for both the Multi-LFT and POC platforms. In parallel, collaboration with impact investors, philanthropic organisations, and local manufacturers is poised to lay the groundwork for post-project scale-up and technology transfer. These actions ensure that HOLICARE’s outcomes are not only scientifically validated but also positioned for sustainable production, distribution, and adoption within African health systems.
Communication, dissemination, and stakeholder engagement have expanded significantly. The HOLICARE website and LinkedIn channels are regularly updated, while the HOLICARE Academy continues to host webinars and training sessions that attract wide participation from both Africa and Europe. Project results have been presented at regional and international conferences, including dedicated workshops on diagnostic innovation and One-Health integration. Communication toolkits and visual materials have been produced to support partner dissemination, enhancing visibility and reinforcing the project’s role as a flagship example of EU–Africa collaboration in health research and innovation.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The HOLICARE project successfully transitioned from a technology development phase to one of active clinical implementation. A key milestone was the completion of the analytical validation for the Multi-Lateral Flow Test (Multi-LFT), paving the way for the commencement of clinical trials across our sites in Senegal, Uganda, and Ethiopia.
Concurrently, the Point-of-Care (POC) instrument evolved significantly, achieving the full integration of both LAMP-based molecular assays and host biomarker immunoassays into a single, compact, and energy-efficient system.
To ensure seamless data flow, we developed a companion mobile application, supported by a robust REDCap-based cloud infrastructure. This ecosystem now enables secure, harmonised, and GDPR-compliant data capture across all our diverse clinical sites, establishing a new standard for traceability and quality control.
Beyond the devices themselves, the project made strategic investments in capacity building. Quality-controlled biobanks and traceability workflows were established. Through the HOLICARE Academy, we trained over 100 healthcare and laboratory professionals via targeted webinars, workshops, and expert exchanges. A landmark achievement for sustainable regional production was reached at the Institut Pasteur de Dakar (IPD), where a state-of-the-art manufacturing facility became operational, boasting an annual production capacity of up to 75 million tests.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

HOLICARE was designed to tackle the most persistent challenges in diagnostics for low-resource settings: constrained laboratory capacity, slow result turnaround, fragmented data connectivity, and prohibitive costs. Our solution transcends the state of the art through a multi-faceted approach. The Multi-LFT is not merely a test strip; it is an integrated diagnostic system. It combines multi-analyte detection with smartphone-based image analysis and a cloud backend, providing immediate clinical interpretation, automatic data storage, and direct integration with national surveillance systems—all from a single test at the point of care. Furthermore, our modular POC platform breaks new ground by integrating both molecular (LAMP) and immunoassay detection in a standard reaction well format, avoiding the need for complex microfluidic cartridges. When coupled with its solar-compatible battery operation and low-energy isothermal amplification, the platform delivers an unprecedented level of efficiency and interoperability. Together, these advances form a cohesive diagnostic ecosystem that seamlessly links field testing, data management, and health-system integration across three African nations, creating a scalable model for future interventions.