Worldwide, infections and death from SAR-CoV-2 continue during with more than 100.000 new cases every day despite lockdown in Europe and oversees. Although most infections are self-limited, about 15% of infected adults develop severe pneumonia that requires treatment with supplemental oxygen and an additional 5% progress to critical illness with hypoxaemic respiratory failure, acute respiratory distress syndrome, and multiorgan failure that necessitates ventilatory support, often for several week. What started as a temporary sanitary issue, has morphed into a more permanent and long-lasting pan epidemic outbreak.
One efficient manner to limit COVID-19 spreading and an adequate means of better managing the COVID-19 outbreak is through unrestrained availability of fast, efficient, accurate and cost-effective point-of-care testing (POCT) device. Here we propose C-POCT-S, a novel and innovative solution to address this medical need: a hand-held surface plasmon resonance (SPR) based POC device sensing for the presence/absence of the SARS-CoV-2 virus. With an assay time of 30 min our solution responds to the need of fast viral state identification. The aim of this project is to complete product optimization, performance validation in a clinical setting and manufacturing quality control of the C-POCT-Sand completion of its technical file, to enable declaration of conformity and affixing of CE mark.
To reach these goals, CorDial-S is based on a combination of several technologies proposed by CorDial-S consortium
- PhotonicSys brings in a handheld surface plasmon resonance (SPR) transducer adapted for diagnostic purposes.
- University of Lille (ULille) brings the surface functionalization and clinical tests methodology of the sensor chip.
- Aix Marseille Université (AUM) provides the consortium with their worldwide knowledge in nanobodies (VHH).
- Magnostics brings the specially developed magnetic nanoparticles with high magnetic strength.
- Université catholique de Louvain (UCL) adds with digital hub know-how.
- University Hospital of Lille (CHU-Lille) performs the clinical validation
- Colmeris MedTech is a consultant responsible for regulatory aspects and marketing authorization of the C-POCT-S.
- Affinité Instruments is the provider of a portable magnetic-SPR diagnostics to be used in the clinical trial study
Commercialisation of the CorDial-S diagnostic will be performed by Biosensing DiagnosticsTM