Combating 2019-nCoV: Advanced Nanobiosensing platforms for POC global diagnostics and surveillance

Project Information

CoNVat

Grant agreement ID: 101003544

DOI

10.3030/101003544

Project closed

EC signature date 6 April 2020

Start date 10 March 2020

End date 9 September 2022

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 2 547 152,48

EU contribution

€ 2 547 152,48

Coordinated by

FUNDACIO INSTITUT CATALA DE NANOCIENCIA I NANOTECNOLOGIA
Spain

Periodic Reporting for period 2 - CoNVat (Combating 2019-nCoV: Advanced Nanobiosensing platforms for POC global diagnostics and surveillance)

Reporting period: 2021-03-10 to 2022-09-09

Summary of the context and overall objectives of the project

The major aim of CONVAT project is to develop innovative solutions for rapid COVID-19 diagnostics in human patients and enable an efficient surveillance of coronavirus in animal reservoir species. In contrast with conventional molecular testing for virus detection, CONVAT exploits the exceptional properties of photonics nanotechnology to provide in-situ real-time identification of the specific viruses with excellent sensitivity and reliability. The primary strategy of CONVAT is to use an photonic nanobiosensor for the label-free detection and quantification of intact SARS-CoV-2 in less than 20 min and directly at the point of care as an efficient way to screen the general population in a non-invasive manner. The BiMW nanosensor will be integrated in a portable and user-friendly device for out-of-the-lab operation, such as primary care centres or pharmacies. The project also encompasses a second approach, which targets the viral RNA analysis for both a SARS-CoV-2 specificity confirmation and a complementary tool for monitoring the coronavirus presence and evolution in animal environments.
At the end of the project, we have upgraded the proposed biosensor in terms of integration and multiplex capabilities. We have demonstrated the detection of intact SARS-CoV-2 viruses with the photonic biosensor, with a time analysis of less than 15 min, with a very high sensitivity, which has set the basis for its future implementation for COVID-19 diagnosis. The genomic approach has not been fully validated as the sensitivity achieved remains slightly low for the analytical requirements. These aspects remain to be finalized in the coming weeks. Overall, CONVAT project has reached crucial milestones towards introducing a unique and powerful technology as a novel diagnostic solution for dealing with emerging pandemics and bettering general healthcare: point-of-care testing, rapid and accurate analysis, high sensitivity and specificity, and easily adaptable to different targets including proteins, nucleic acids, viruses or bacteria.

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 work performed during the project execution has led to the following main results:
- Collection of clinical human samples (20.000) and animal reservoir samples (350). A part of them has been fully characterized.
- High quality biological reagents for diagnostics, including viral antigens, antibodies, genomic material, and inactivated virus samples have been produced.
- A photonic biosensor-based serology test for the detection of specific antibodies generated after infection has been established and fully validated with more than 100 clinical samples, demonstrating excellent diagnostic sensitivity and specificity.
- A biosensor methodology for the direct detection of intact SARS-CoV-2 viruses has been set up, demonstrating the detection of viruses in less than 15 min, with a sensitivity of around 100 FFU/mL.
- A direct hybridization assay for the detection of SARS-CoV-2 RNA strains has been evaluated. The sensitivity achieved at the end of the project has not been sufficient for the analysis of real samples, and additional efforts have been concentrated on the sensitivity enhancement.
- The BiMW biosensor prototype is being upgraded and prepared for integration and portability. Work has been done in microfluidics design, BiMW multiplexing sensor chips fabrication, electronics integration, signal readout, and software.
The CoNVAT technology have attracted huge interest from industry and investors, as well as the social and scientific media, and general population. At the European level, the CoNVat project has been mentioned in nearly 200 individual pieces globally and has also been publicized and participated in institutional communication channels.
The project has delivered relevant data related to SARS-CoV-2 molecular characterization and diagnostic tools which are shared in open-access repositories and platforms like the EVAg and GISAID, available for researchers, industrials, and the general population. Moreover, the CONVAT project and the results have been presented and shared in scientific publications (33 peer-review journals, conferences, and workshops). We have been contacted by a large number of international small, medium and large companies and private investors to know more about the maturity and the degree of development of the biosensor tests. The exploitation roadmap is essentially focused on the technological transfer of biosensor devices and approaches as in-vitro diagnostic systems. Several exploitable results included the photonic biosensors employed and upgraded during the project, the serology and virus detection assays, and the methodologies for sensor chip biofunctionalization and storage. Related to the serology assay, ICN2 has registered three Trade Secrets related to the technology and the assay. The excellent track-record of the ICN2 partner in developing optical biosensors for biomedical and clinical applications, together with the good results achieved during the CONVAT project, has boosted the upcoming creation of a new spin-off company for the commercialization of the photonic biosensors as new in-vitro diagnostic (IVD) systems.

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)

CONVAT is one of the first large European projects in COVID-19 diagnostics that bets for pioneering photonics nanotechnology as potential solution for rapid, efficient, and accurate detection of SARS-CoV-2. The development and validation of CONVAT biosensor for clinical diagnosis could definitely boost the implementation of novel technologies for improved global healthcare, promoting point-of-care testing and efficient population screenings. Besides, the application of CONVAT biosensor technology for environmental control and surveillance would greatly facilitate the monitoring of potential emerging viruses and help in the prevention of future outbreaks and epidemics. It is worth mentioning the frequency of epidemic or pandemic situations to increase in the coming years, revealing the importance of being more prepared, by having powerful tools, capable of operating in decentralized settings, that allow the tracking and monitoring of future pathogen outbreaks in wildlife and identify possible future spillovers. It is of major importance to address the "animal to humans" risk of transmission to be able to operate a "Preparedness and Response" plan as advocated by WHO Research and Development Blueprint document.
The scientific research carried out within the CONVAT project has delivered relevant data shared in open access repositories and platforms like the EVA, available for researchers, industrials, and the general population. Moreover, the CONVAT project and resultant outcomes have been presented and shared in nearly 100 online conferences and more than 30 peer-review articles have been already published. Outside academia, CONVAT has attracted massive attention from the media and the general society, mainly at the Spanish national level but also at European and International level, contributing to increasing the outreach of the research carried out. It has been mentioned in more than 300 interviews and stories so far, published in television, radio, and press. We expect that the technology output of CoNVat will become a strong competitor in existing markets of in vitro diagnostics and will open possibilities in potentially larger new markets, such as that of bacteria diagnosis and antimicrobial profiling, among other applications for IVD in the clinical practice.

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