We defined 8 specific and measurable objectives:
1. End-User direction assessment/evaluation of existing solutions; gaps; and lessons learnt from previous pandemics;
Lessons learnt are integrated in the CONOPS and consolidated in the ONELAB Guidance for Pandemic Testing Policies and the Pandemic Testing Playbook. End-user workshops in 6 countries assessed implementation of MCT and lessons learnt during the COVID-19 pandemic resulting in D2.4 P.E.L.S. analysis and was complemented with the citizen survey on awareness, acceptance and trust. The information was used to develop and evaluate the 2 Field Technical Exercises (FTX) and the readiness and capability assessment framework in D6.2.
2. NG RRML designed, developed & delivered to provide analytical quality by design in accordance with ICH 2 to meet wide range of monitoring mission goal.
The CONOPS provided a framework for the development of NGML. D5.1 describes detailed guidelines and workflows for both clinical studies and FTXs that ensure the implementation of analytical quality by design throughout the project development, validation and testing. ‘Lessons learned’-elements of D5.1 are again captured in D6.1 and D6.2.
3. Staged diagnostic capability and capacity for delivery of reliable and unambiguous detection and identification of infectious agents across all pandemic phases.
The CONOPS integrates current and future standards to take into account for the NGML Complementary diagnostic modalities; breath-based VOC profiling by GC-IMS and GC-MS, handheld sensor measurements, LC-MS assays were demonstrated. During the multi-centre clinical studies and in the FTX Pre-emptive exercise, outcomes consisting of blinded multi-site data, were integrated and analysed using AI/ML pipelines. Together with the 5-28-100 mobilisation premise and the Pandemic Testing Readiness scoring dashboard in D6.2 they provide a structured approach for scaling diagnostic capacity and capability across different pandemic phases.
4. ICT and data hub for field data communication & processing to facilitate decision-making by chain of command and authorities
The CONOPS provides a framework to support requirements for secure data flows, interoperability with public-health surveillance and the role of ICT. We developed an integrated ICT and data hub enabling secure multi-channel connectivity and structured storage, quality control and pre-processing of clinical and laboratory data and successfully deployed this during clinical studies and the FTX exercises.
5. Defining, classifying, and incorporating societal factors, constraints, and heuristics
The CONOPS explicitly addresses citizens’ trust and acceptance, policy objectives, ethical and legal principles and societal trade-offs in pandemic testing. In WP5&6, societal factors (inclusiveness, positive patient experience, non-intrusive sampling, accessibility, communication and trust) were incorporated in the definition of FTX scenarios, the Pandemic Testing Playbook and the ‘Assessment and capability framework’.
6. NG CONOPS for mobile pandemic monitoring operations.
D3.1 D2.4 D6.2.
7. Establish a worldwide pandemic community-testing forum
The online forum is operational and accessible via the website:
https://onelab-project.eu/(odnośnik otworzy się w nowym oknie)8. Promote international cooperation on pandemics with Japan, build scalable capacities for joint multinational intervention
The Japanese project partner made substantial contributions (integrated in D3.1) as one of the participating sites for the multicentre clinical studies and key sparring partners in the development of the FTX’s and RRML solution
