We are pleased to announce that Mologic’s COVID-19 laboratory and point of need antibody tests have both graduated from research and development, achieved design freeze and are ready for manufacture.
Both COVID-19 tests have been independently assessed by the Liverpool School of Tropical Medicine (LSTM) and St George’s University of London (SGUL) and are now being prepared for launch with CE mark. Mologic is proactively engaging with further independent validation groups, including the UK government, the World Health Organization, and the Africa CDC.
Clinical performance of IgG ELISA among known COVID-19 cases (PCR positive >10 days of diagnosis):
- Sensitivity 99% and Specificity 98%
- Total PCR positive cases tested 101
- Total negative cases tested 314 (pre-2019)
Mologic will be announcing several critical milestones in the coming week, including open access publication of the full data and additional results.
The unprecedented speed of this initiative has only been possible thanks to the openness, collaboration, and effort of all laboratory, clinical, logistics, and support staff. We have been humbled by those who have volunteered to assist Mologic in any way, to help us reach this remarkable juncture in just 6 weeks.