Rapid development of COVID-19 rapid diagnostics for low resource settings: accelerating delivery through transparency, responsiveness, and open collaboration

Adams, Emily R; Augustin, Yolanda; Byrne, Rachel L; Clark, David J; Cocozza, Michael; Cubas-Atienzar, Ana I; Cuevas, Luis E; Cusinato, Martina; Davies, Benedict M. O.; Davies, Mark; Davies, Paul; Duvoix, Annelyse; Eckersley, Nicholas M; Edwards, Thomas; Fletcher, Thomas; Fraser, Alice j; Garrod, Gala; Hadcocks, Linda; Hu, QInxue; johnson, Michael; Kay, Grant A; Keymer, Katherin; Kirwan, Daniela; Klekotko, Kesja; Lewis, Zawditu; Mason, Jenifer; Mensah-Kane, Josie; Menzies, Stefanie; Monahan, Irene; Moore, Catherine M; Nebe-von-Caron, Gerhard; Owen, Sophie I; Planche, Tim; Sainter, Chris; Schouten, James; Staines, Henry M; Turtle, Lance; Williams, Chris; Wilkins, John; Woolston, Kevin; Sall, Amadou A; Fitchett, Joseph R.A.; Krishna, Sanjeev

In January, Mologic, embarked on a product development pathway for COVID-19 diagnostics focusing on ELISA and rapid diagnostic tests (RDTs), with anticipated funding from Wellcome Trust and DFID. 755 clinical samples from known COVID-19 patients and hospital negative controls were tested on Mologics IgG ELISA. The reported sensitivity on 191 SGUL prospectively enrolled patients was 95% on day 7 or more post diagnosis, and 97% 10 days or more post-diagnosis. A specificity panel comprising 564 samples pre-December 2019 were tested to include most common respiratory pathogens, other types of coronavirus, and flaviviruses. Specificity in this panel was 97%. This is the first in a series of Mologic products for COVID-19, which will be deployed for COVID-19 diagnosis, contact tracing and sero-epidemiological studies to estimate disease burden and transmission with a focus on ensuring access, affordability, and availability to lowest resource settings.