There is a huge need for rapid detection of COVID cases in order to achieve appropriate clinical management and infection control and adoption of community mitigation efforts.
The wide availability of testing capabilities in health care settings, reference and commercial labs and especially outside the hospital and at the point-of-care is now mandatory.
The delivery of tools for SARS-CoV-2 detection at the point-of-care is related to the following challenges: availability of robust, sensitive, cost-effective and rapid devices and tests; validation in clinical settings using real samples; availability of stable reagents for assays; and fast-track certification for immediate release and impact.
To address the above challenges, we are proposing a targeted approach to deploy a novel, yet mature technology for SARS-CoV-2 and other relevant viruses’ detection. We are focusing on the following:
Fast-track validation, certification (IVDD) and release of a device and two assays suitable for the doctor’s office, intensive care units, reference labs, or any other place where DNA extraction can take place, with the aim to achieve a result in <30 min.
Cost-optimization and large-scale production of the device and reagents to allow fast uptake by end users
Full certification (IVDR) of the device and advanced methodology for two assays for point-of-care applications, the latter referring to a COVID-19 and influenza testing directly in crude samples (swab and/or saliva)
Promote results obtained within the project by sharing data and methods with other groups working in the EU and globally towards achieving the same goals
Engagement of end users globally
Establishing commercial links for product distribution
Prof. Electra Gizeli
Foundation for Research and Technology – Hellas (FORTH)