Empowering Africa's Point of Care with Cutting-edge Graphene Biosensing for Rapid Detection and Interconnected Surveillance of Novel Ebola Virus Outbreaks.

Projektinformationen

EPoCA

ID Finanzhilfevereinbarung: 101145795

DOI

10.3030/101145795

EK-Unterschriftsdatum 11 Juni 2024

Startdatum 1 Juli 2024

Enddatum 30 Juni 2027

Finanziert unter

• Health

Gesamtkosten

€ 2 926 130,00

EU-Beitrag

€ 2 920 255,00

Koordiniert durch

LIBELIUM COMUNICACIONES DISTRIBUIDAS SL
Spain

Periodic Reporting for period 1 - EPoCA (Empowering Africa's Point of Care with Cutting-edge Graphene Biosensing for Rapid Detection and Interconnected Surveillance of Novel Ebola Virus Outbreaks.)

Berichtszeitraum: 2024-07-01 bis 2025-12-31

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

Ebola virus disease (EVD) remains a high-consequence public health threat, carrying a fatality rate of up to 90%. The threat is particularly severe in sub-Saharan Africa, where laboratory capacity, logistics, and connectivity are often heavily constrained. Traditional laboratory-based tests, while highly accurate, are resource-intensive and time-consuming, frequently delaying critical patient management and outbreak containment. Rapid diagnosis at the point of care (PoC) is essential to initiate appropriate clinical management and support timely outbreak responses.
The EPoCA project aims to develop, clinically validate, and deploy a highly innovative, multiplexed point-of-care biosensing platform based on graphene field-effect transistor (BioGFET) sensors. The platform is designed to quantify Ebola virus biomarkers alongside host-response and severity biomarkers from a minimal volume of blood. Diagnostic results are securely networked through an Internet of Things (IoT) infrastructure and an artificial intelligence (AI)-enabled sentinel service, supporting near real-time situational awareness and early warning across multiple sites.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

During Reporting Period 1, EPoCA achieved the following technical and scientific milestones:
1. BioGFET Functionalisation & Biomarker Strategy (WP3)
Workflow: Developed a step-by-step GFET functionalisation process. Evaluated two immobilization routes: random (PASE) and oriented (PBH), the latter preserving higher antigen-binding availability.
Stability: Integrated a PDMS microfluidic capsule; sensors demonstrated stable electrical behavior for up to 7 days in buffer, confirming field-readiness.
Multiplex Panel: Finalized a dual-target strategy combining Ebola proteins and host-response biomarkers for simultaneous infection detection and patient stratification.
2. Data Governance & Smart Data Models (WP4/Cross-cutting)
Framework: Established a FAIR-aligned Data Management Plan (DMP) and a secure GitLab repository for traceable, consortium-wide collaboration.
Interoperability: Produced "Ebola Outbreaks Smart Data Models" using NGSI-LD and JSON Schemas. Defined core entities (Patient, Sample, TestResult, Biosensor, Alert) to ensure machine-actionable data exchange across all platform tiers.
3. IoT–Edge–Cloud Architecture (WP4)
Design: Implemented an "edge-by-design" blueprint integrating Libelium One, Orion-LD (FIWARE), and MQTT protocols.
Resilience: Developed store-and-forward buffering with local encryption to ensure data continuity during WAN outages in resource-limited settings.
Analytics: Integrated edge-based processing for real-time anomaly detection and "sentinel" alerts, reducing dependency on cloud connectivity.
Security: Embedded TLS communication, RBAC, and end-to-end encryption to meet regulatory and DMP requirements.
4. Regulatory and Clinical Readiness (WP5/WP6)
Compliance: Classified the device under EU MDR 2017/745 (hardware) and IVDR 2017/746 (biologicals). Mapped QMS and Risk Management to ISO 13485 and ISO 14971.
Field Readiness: Obtained ethics approvals for sites in the DRC (INRB) and Ghana (NMIMR). Confirmed BSL-3 laboratory capacity and secured access to >10,000 archived blood samples for immediate analytical validation of the upcoming prototype.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

EPoCA advances point-of-care (PoC) diagnostics by integrating multiplexed graphene biosensing, standardized health data models, and a resilient IoT–Edge–Cloud stack.
GFET Innovation: Developed an oriented antibody immobilization workflow for GFET biosensors. This increases sensitivity and reproducibility while remaining compatible with automated, large-scale manufacturing.
Semantic Interoperability: Established an NGSI-LD semantic foundation for Ebola surveillance (aligned with FIWARE). This enables machine-readable data exchange and seamless integration with global digital health infrastructures.
Resilient Architecture: Implemented an "edge-by-design" system that processes data locally for rapid alerting and synchronizes with the cloud for longitudinal analysis, ensuring functionality during network outages.
Overview of Results
Validated Functionalization: Oriented antibody-based GFET method optimized for scalability.
Smart Data Models: NGSI-LD entities for Ebola measurements and alerts (FAIR-compliant).
Reference Architecture: Standards-based IoT–Edge–Cloud platform with local analytics and secure synchronization.
Governance Framework: Ethical and regulatory foundations for responsible human sample use and cross-border compliance.
Potential Impacts
Rapid Response: Reduces time-to-result for clinicians, strengthening early warning and situational awareness in laboratory-limited settings.
System Integration: Lower barriers for integrating PoC data into broader health ecosystems and potential adaptation for other infectious threats.
Key Needs for Further Uptake and Success
Demonstration: Continued optimization of sensor robustness, cartridge integration, and field-testing.
Clinical Evidence: Completion of clinical validation to prove performance against reference methods (RT-PCR/ELISA).
Regulatory Alignment: Compliance with IVD regulations (IVDR) and continued commitment to interoperability standards (NGSI-LD).
Commercialization: Development of sustainable business models, procurement strategies, and investment-ready propositions.
IPR and Internationalization: Strategic management of assets and hardware know-how to enable fair access through global partnerships.
Social Acceptance: Sustained Risk Communication and Community Engagement (RCCE) to build trust and ensure cultural acceptability in vulnerable regions.