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 1 - HoliCare (A holistic approach in patient management and epidemic surveillance through convergence of diagnostic technologies, capacity building and stakeholder engagement)

Reporting period: 2022-09-01 to 2024-02-29

Summary of the context and overall objectives of the project

The HOLICARE project aims to revolutionize healthcare in sub-Saharan Africa, focusing on combating Poverty-Related Diseases (PRDs). We will introduce novel diagnostic tools suitable for areas with limited resources, improve healthcare infrastructure, and empower local healthcare workers through advanced technologies and training. Notable progress has been made in developing advanced diagnostic solutions tailored for Low- and Middle-Income Countries (LMICs). These include multiplexed lateral flow tests (Multi-LFT) for quick screening and a Point-of-Care (POC) instrument for precise pathogen identification and biomarker quantification. These innovations, coupled with digital solutions for streamlined data management and connectivity, represent a significant advancement in Point-of-Care diagnostics for resource-constrained environments.

The project has taken a two-tiered approach: the development of Multi-LFT connected to a mobile reader for digital connection and the creation of a POC instrument for key biomarkers. Efforts have also been directed towards enhancing infrastructural capacity and human capital development, including the establishment of quality-controlled biobanks and training initiatives. Achievements include the development of comprehensive diagnostic solutions tailored for LMICs and the creation of an infectious diseases mobile reader for point-of-care use in lower respiratory tract infections.

Addressing unmet needs in the diagnostics field, HOLICARE has developed a multi-LFT system that combines the simplicity of lateral flow assays with smartphone connectivity and cloud-based data storage. This allows for rapid digitization and transfer of diagnostic data, ensuring immediate availability for actionable insights. Additionally, the development of a POC instrument as a second tier of information holds promise for reshaping healthcare delivery in resource-limited settings. Challenges such as limited diagnostics infrastructure, high costs, and lack of connectivity are being addressed through these innovative solutions, paving the way for improved healthcare accessibility and outcomes in the region.

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

On the technical part, HOLICARE has focused on a two-tiered approach, one being multi-LFT combined with mobile based reader application and the other one on POC instrument for key biomarkers.

Significant efforts were dedicated to developing diagnostic solutions tailored specifically for Low- and Middle-Income Countries (LMICs). This included the creation of multiplexed lateral flow tests (Multi-LFT) for rapid screening and a Point-of-Care (POC) instrument for precise pathogen identification and biomarker quantification. Notable advancements included the development and implementation of Multi-LFT with digital solutions for data management and connectivity. In parallel, HOLICARE has worked on enhancing the infrastructural capacity, in particularly to support the deployment and utilization of advanced diagnostic technologies and establishing quality-controlled biobanks and fostering human capital development through training initiatives. The establishment of quality-controlled biobanks and the implementation of targeted training initiatives contributed to enhancing infrastructural capacity and human capital development, laying the foundation for sustainable healthcare improvements in the region.

Main achievements include the development of comprehensive diagnostic solutions tailored for LMICs, including Multi-LFT connected to mobile reader for digital connection and a versatile POC instrument capable of integrating various diagnostic modalities. Towards digitalising the healthcare at LMICs, iSTOC has developed an infectious diseases mobile reader which will become a turnkey solution for healthcare professionals to be used in POC settings for infectious diseases of lower respiratory tract. The solution will consist of a smartphone mobile reader application and a cloud backend solution. With very minimal instructions to untrained staff, the solution can be deployed to capture lateral flow test (LFT) diagnostic data, digitise it and automatically transfer the data to the cloud. In parallel, we are developing a flexible POC instrument that will allow the quantification of a wide range of biomakers of interest.

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)

We are developing beyond the state of the art technical solutions by addressing some of the unmet needs in the diagnostics field. Currently, many POC test measurement devices are test-specific and usually do not have wireless connection to cloud services. Most individuals have to visit clinics to get tested and wait for final confirmation of the laboratory results for days. Much of the of patient data related to POC testing is still manually recorded. Moreover, access to medical consultation following test result confirmation is often delayed due to heavy workload among healthcare professionals. The main challenge, especially in resource limited settings, are the following:
- Limitations in diagnostics infrastructure leads to lack of Connectivity at Point of Care
- Bureaucracy, lack of healthcare providers (HCPs), and human error are barriers to reliable diagnostic verification
- High cost of diagnostics reduce access to best possible patient treatment
- Too often expensive and mono-functional hardware limits the benefits of integrated mobile solutions

We have developed a multi-LFT that combines the ease of use of use of lateral flow assay with a smartphone mobile reader application and a cloud backend solution to deliver truly integrated digital healthcare. With very minimal instructions to untrained staff, the solution can be deployed to capture lateral flow test (LFT) diagnostic data, digitise it and automatically transfer the data to the cloud. The mobile application can be used by a test operator at a point of care screening site or by a technician in the field. After the scan has been performed, the results of the LFT are available immediately on both the mobile application and the cloud service. This ensures the data is immediately available where it is actionable, either at the screening site or at a central care facility. In addition, while still under development, the POC instrument that can be used for quantification of a range of key biomarkers is novel and poised to reshape the delivery of health care at resource limited settings.