RE: ODX manufacturing for AVCT????5 Jan 2021 09:19
On the Mologic antigen test issue, the publicly stated position is:
"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 (<5×10^2 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 in January 2021. The data is available on request, pending full publication of results."
Given that further studies are ongoing, I would suggest that making assertions around the effectiveness of the test is unwise. Let's wait for the final results later this month. All I will say is that it is extremely unlikely that a company like Mologic, which is highly regarded internationally, would risk it's reputation by CE marking a test it was not satisfied met the relevant requirements.