Mologic a developer of lateral-flow and rapid diagnostic technologies, has announced that its professional-use COVID-19 Rapid Antigen Test has now been certified with a CE mark.
Certification followed independent assessment by the Liverpool School of Tropical Medicine (LSTM). The test will provide health professionals with 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-qPCR-confirmed COVID-19 cases. Limit of detection studies estimate a 50% tissue culture infectious dose (TCID50/mL) of 100–350 (<5x102 pfu/mL), a key tool for estimating the infectious titre of a virus.
Considering the preliminary number of patients included so far, further studies are planned across the UK, with St George’s University of London, Northumbria Healthcare NHS Foundation Trust, Imperial College London, Nottingham University Health Trust, and the Hull Royal Infirmary, with expected report findings later this month.