RESUMEN
We report dynamics of seroconversion to SARS-CoV-2 infections detected by IgG ELISA in 177 individuals diagnosed by RT-PCR. Longitudinal analysis identifies 2-8.5% of individuals who do not seroconvert even weeks after infection. They are younger than seroconverters who have increased co-morbidity and higher inflammatory markers such as C-Reactive Protein. Higher antibody responses are associated with non-white ethnicity. Antibody responses do not decline during follow up almost to 2 months. Serological assays increase understanding of disease severity. Their application in regular surveillance will clarify the duration and protective nature of humoral responses to SARS-CoV-2.
RESUMEN
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.