Periodic Reporting for period 1 - DECIPHER (Decentralized microfluidic in vitro diagnostic patch for pandemic control)
Período documentado: 2024-01-01 hasta 2025-06-30
The DECIPHER consortium aims to revolutionize the in vitro diagnostic (IVD) point-of-care (POC) field by developing for the first time a true quantitative sample-to-result POC test based on a re-purposed glucose meter, supported by socio-economic system analysis and artificial intelligence (AI)-based models for efficient and effective implementation in the field.
IVD technologies have revolutionized healthcare but because they still depend on a laboratory environment for quantitative results, they remain bound to the traditional centralized healthcare approach. Hence, over the past decade, we have witnessed enormous efforts in the IVD field to bring lab-quality bioassays from the lab to the POC (i.e. clinics, homes, and remote communities). While some qualitative RDTs have reached the market, they still require manual off-chip pre-processing of sample (e.g. metering or dilution). This limits their usage to only trained and experienced operators, therefore preventing their broad implementation as POC devices. Moreover, the COVID-19 pandemic has confronted medical device developers with the many access and practical issues encountered from the end-user side.
The DECIPHER consortium will develop an innovative microfluidic-based DECIPHER patch capable of both biofluids (self-)sampling via hollow microneedles (HMNs) and immediate analysis of this sample on the very same patch in a completely self-powered manner, producing a quantitative result to be read out with a re-purposed glucose meter. Ebola and Lassa viruses are selected as relevant model systems because they are highly contagious with human-to-human transmission, high mortality rate and no vaccine/treatment available, thus having a meaningful potential for new pandemic threats.
To offer such a genuine sample-to-result quantitative POC solution, the DECIPHER value chain will, besides innovations in the field of high-throughput manufacturing processes based on novel photopolymers, microfluidics and HMNs, focus on (1) novel quantitative molecular bioassays, (2) analytical and clinical validation (both retrospective and prospective), (3) AI-based models, (4) socio-economic/systems analysis and (5) life cycle assessment. This true interdisciplinarity will be represented by the highly experienced DECIPHER consortium with partners from 3 universities, 5 research institutes, 2 companies and 1 non-governmental organization from 6 countries.
In the DECIPHER project, we aim to contribute to the EU pandemic preparedness program by providing innovative and flexible solutions deployable on short-term upon pandemic threats identification. In this context, flexibility of an IVD infrastructure is key since the source of the next big pandemic cannot be fully predicted. Therefore, the DECIPHER project will use a multifaceted approach, combining quantitative molecular IVD tests with AI-based predictive disease modelling, next to assessing the socio-economic sustainability of this approach.
IVD technologies have revolutionized healthcare but because they still depend on a laboratory environment for quantitative results, they remain bound to the traditional centralized healthcare approach. Hence, over the past decade, we have witnessed enormous efforts in the IVD field to bring lab-quality bioassays from the lab to the POC (i.e. clinics, homes, and remote communities). While some qualitative RDTs have reached the market, they still require manual off-chip pre-processing of sample (e.g. metering or dilution). This limits their usage to only trained and experienced operators, therefore preventing their broad implementation as POC devices. Moreover, the COVID-19 pandemic has confronted medical device developers with the many access and practical issues encountered from the end-user side.
The DECIPHER consortium will develop an innovative microfluidic-based DECIPHER patch capable of both biofluids (self-)sampling via hollow microneedles (HMNs) and immediate analysis of this sample on the very same patch in a completely self-powered manner, producing a quantitative result to be read out with a re-purposed glucose meter. Ebola and Lassa viruses are selected as relevant model systems because they are highly contagious with human-to-human transmission, high mortality rate and no vaccine/treatment available, thus having a meaningful potential for new pandemic threats.
To offer such a genuine sample-to-result quantitative POC solution, the DECIPHER value chain will, besides innovations in the field of high-throughput manufacturing processes based on novel photopolymers, microfluidics and HMNs, focus on (1) novel quantitative molecular bioassays, (2) analytical and clinical validation (both retrospective and prospective), (3) AI-based models, (4) socio-economic/systems analysis and (5) life cycle assessment. This true interdisciplinarity will be represented by the highly experienced DECIPHER consortium with partners from 3 universities, 5 research institutes, 2 companies and 1 non-governmental organization from 6 countries.
In the DECIPHER project, we aim to contribute to the EU pandemic preparedness program by providing innovative and flexible solutions deployable on short-term upon pandemic threats identification. In this context, flexibility of an IVD infrastructure is key since the source of the next big pandemic cannot be fully predicted. Therefore, the DECIPHER project will use a multifaceted approach, combining quantitative molecular IVD tests with AI-based predictive disease modelling, next to assessing the socio-economic sustainability of this approach.
In the DECIPHER project, we have developed dynamic photopolymers that enable local thermal lamination upon UV-light activation. Additionally, we have successfully established both electrostatic-based and covalent surface functionalization strategies, as a crucial step towards biomolecule immobilization onto the DECIPHER microfluidic chip. Moreover, we have developed all the required microfluidic elements (5 novel modules) to support liquid operations of the bioassay inside the DECIPHER cartridge, which were validated with the real bioassay reagents. Next, the majority of the required bioassay aspects have been developed off-chip and the first steps towards its implementation onto the microfluidic cartridge have been taken by showing a proof-of-concept of electrochemical glucose readout using integrated commercial glucose strips. In addition, we have established a scalable protocol for fabricating HMN arrays capable of sampling capillary blood, exhibiting a high-quality surface finish with sharp tip geometry. Furthermore, as the integration of social sciences and humanities represents a key component of this project, we have conducted a stakeholder mapping and analysis for viral haemorrhagic fever (VHF) diagnostics. Besides, we gathered, processed, and displayed high-resolution spatial contextual data for Nigeria, Guinea, and DRC, using a customized geoportal. Also, a vulnerability index was developed to support prioritization of interventions and spatio-temporal data was integrated into the platform. Finally, regarding life cycle assessment, information gathering has been started to define the system boundaries and the functional unit of the DECIPHER cartridge, as well as information collection on the material flows with respect to the different steps of the production process.
The DECIPHER project will contribute beyond the state of the art to the following impacts:
- Innovation in and scale-up of photopolymer-based microfluidic devices by fabrication via R2R processes as well as the development of digital solutions for the health care via AI-based disease outbreak modelling. Moreover, we will show the synergy between hardware (i.e. microfluidic device) and software (i.e. AI) to achieve superior overall performance for pandemic prevention.
- Reduced burden of diseases in the EU and worldwide through the unique combination of (1) an innovative quantitative self-powered IVD patch, enabling early stage diagnosis, thereby improving treatment and patient isolation, with (2) system dynamics modelling and a digital AI-based outbreak predictive tool, ensuring high acceptance and uptake of the test (e.g. by stakeholder involvement) and optimized resources use (e.g. optimal locations to screen, number of tests to deploy).
- Innovation in and scale-up of photopolymer-based microfluidic devices by fabrication via R2R processes as well as the development of digital solutions for the health care via AI-based disease outbreak modelling. Moreover, we will show the synergy between hardware (i.e. microfluidic device) and software (i.e. AI) to achieve superior overall performance for pandemic prevention.
- Reduced burden of diseases in the EU and worldwide through the unique combination of (1) an innovative quantitative self-powered IVD patch, enabling early stage diagnosis, thereby improving treatment and patient isolation, with (2) system dynamics modelling and a digital AI-based outbreak predictive tool, ensuring high acceptance and uptake of the test (e.g. by stakeholder involvement) and optimized resources use (e.g. optimal locations to screen, number of tests to deploy).