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

  1. Emily R Adams
  2. Yolanda Augustin
  3. Rachel L Byrne
  4. David J Clark
  5. Michael Cocozza
  6. Ana I Cubas-Atienzar
  7. Luis E. Cuevas
  8. Martina Cusinato
  9. Benedict M O Davies
  10. Mark Davis
  11. Paul Davis
  12. Annelyse Duvoix
  13. Nicholas M Eckersley
  14. Thomas Edwards
  15. Tom Fletcher
  16. Alice J Fraser
  17. Gala Garrod
  18. Linda Hadcocks
  19. Qinxue Hu
  20. Michael Johnson
  21. Grant A Kay
  22. Katherine Keymer
  23. Daniela Kirwan
  24. Kesja Klekotko
  25. Zawditu Lewis
  26. Jenifer Mason
  27. Josie Mensah-Kane
  28. Stefanie Menzies
  29. Irene Monahan
  30. Catherine M Moore
  31. Gerhard Nebe-von-Caron
  32. Sophie I Owen
  33. Tim Planche
  34. Chris Sainter
  35. James Schouten
  36. Henry M Staines
  37. Lance Turtle
  38. Chris Williams
  39. John Wilkins
  40. Kevin Woolston
  41. Amadou Alpha Sall
  42. Joseph R A Fitchett
  43. Sanjeev Krishna
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Abstract

Here we describe an open and transparent consortium for the rapid development of COVID-19 rapid diagnostics tests. We report diagnostic accuracy data on the Mologic manufactured IgG COVID-19 ELISA on known positive serum samples and on a panel of known negative respiratory and viral serum samples pre-December 2019.

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.

834 clinical samples from known COVID-19 patients and hospital negative controls were tested on Mologic’s IgG ELISA. The reported sensitivity on 270 clinical samples from 124 prospectively enrolled patients was 94% (95% CI: 89.60% - 96.81%) on day 10 or more post laboratory diagnosis, and 96% (95% CI: 84.85% - 99.46%) between 14–21 days post symptom onset. A specificity panel comprising 564 samples collected pre-December 2019 were tested to include most common respiratory pathogens, other types of coronavirus, and flaviviruses. Specificity in this panel was 97% (95% CI: 95.65% - 98.50%).

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 low-resource settings.

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