Market Release of a Portable Device for COVID-19 at the Point-of-Care; a Global Diagnostics Approach

The current pandemic of the coronavirus, reported first on 31st December 2019 in China, has produced a global alert of unprecedented nature. From the beginning, immediate actions have been put in place by all relevant stakeholders, i.e., local health departments, governments, pharmaceutical companies, global organisations etc., to address the problem as quickly as possible and control the spread of the disease. Large scale testing of symptomatic and asymptomatic patients/citizens has been one of the most effective measures taken by several countries, combined with isolation and tracking. Today, after six months from the outbreak, the deaths continue to rise with over 200 affected countries. Fear of a new wave of the pandemic together with the ongoing cases worldwide make the need for developing rapid and accurate diagnostic tools for COVID-19 a global priority, as declared by the WHO. The current consortium aims to join forces in the battle against the coronavirus by producing mature and robust solutions with immediate impact. The proposal is built around the implementation of an existing and patented device and methodology based on isothermal LAMP amplification and real time quantitative colorimetric detection. This mature methodology, currently of a technology readiness level of 7, has already been proven to be able to detect SARS-CoV-2 in patients'Äô samples with 97.4% sensitivity and 100% specificity. The main objectives of this proposal are thus the immediate deployment of the device following clinical validation and fast track certification. Arrangements for the large-scale production of the device and reagents will take place in parallel, followed by the provision of a full medical certification for COVID-19 and flu detection directly in crude samples and at the point-of-care. Global uptake of the two certified products together with global sharing of the project results are important deliverables of the proposal for the current and future epidemics.