Mologic receives CE mark for COVID-19 rapid antigen test
Mologic’s professional-use COVID-19 Rapid Antigen Test has been certified with a CE mark. The test provides health professionals an accurate detection of the nucleoprotein of the SARS-CoV-2 virus in respiratory swabs, within 10 minutes. Development and validation were supported by the Wellcome Trust and the Foreign, Commonwealth and Development Office (FCDO) Joint Initiative on Research in Epidemic Preparedness and Response.
Independent assessment at Liverpool University Hospitals NHS Foundation Trust, as part of the FASTER study with 28 patients presenting for care, resulted in a sensitivity of 92%, and a specificity of 100%, corresponding to RT-qPCRconfirmed COVID-19 cases.
Global validation trials have begun with the Institut Pasteur de Dakar in Senegal, West Africa and will commence in Boston, USA, and in Jakarta, Indonesia, from January 2021. Dossiers will be prepared for submission to the US FDA and WHO at that same time.
To guarantee access to the rapid test in low- and middle-income countries, the COVID-19 Rapid Antigen Test will be manufactured and made available by Global Access Diagnostics (GAD), at cost of production and distributed through commercialisation partners.
Dr Joe Fitchett, Medical Director and Epidemics lead, Mologic, commented: “The findings are preliminary but very encouraging. We are therefore extending trials in the UK, the US,
Senegal, and Indonesia thanks to support from the Wellcome Trust. We look forward to transferring the COVID-19 Rapid Antigen Test for joint manufacture in Europe and in Africa with the Institut Pasteur de Dakar in Senegal.”
Prof. Luis Cuevas, Liverpool School of Tropical Medicine, said: “Mologic’s low-cost rapid antigen detection tests will signal a step change for health services in low- and middle-income countries, where the supply of tests is limited.”
For more information, visit: https://mologic.co.uk
