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Rapid development of COVID-19 rapid diagnostics for low resource settings: accelerating delivery through transparency, responsiveness, and open collaboration
Preprint
en Inglés
| medRxiv
| ID: ppmedrxiv-20082099
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 Mologics 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.
cc_by_nc_nd
Texto completo:
Disponible
Colección:
Preprints
Base de datos:
medRxiv
Tipo de estudio:
Estudio diagnóstico
/
Estudio observacional
/
Estudio pronóstico
Idioma:
Inglés
Año:
2020
Tipo del documento:
Preprint