PT  - JOURNAL ARTICLE
AU  - Brandi Freeman
AU  - Sandra Lester
AU  - Lisa Mills
AU  - Mohammad Ata Ur Rasheed
AU  - Stefany Moye
AU  - Olubukola Abiona
AU  - Geoffrey B. Hutchinson
AU  - Maria Morales-Betoulle
AU  - Inna Krapinunaya
AU  - Ardith Gibbons
AU  - Cheng-Feng Chiang
AU  - Deborah Cannon
AU  - John Klena
AU  - Jeffrey A. Johnson
AU  - Sherry Michele Owen
AU  - Barney S. Graham
AU  - Kizzmekia S. Corbett
AU  - Natalie J. Thornburg
TI  - Validation of a SARS-CoV-2 spike protein ELISA for use in contact investigations and sero-surveillance
AID  - 10.1101/2020.04.24.057323
DP  - 2020 Jan 01
TA  - bioRxiv
PG  - 2020.04.24.057323
4099  - http://biorxiv.org/content/early/2020/04/25/2020.04.24.057323.short
4100  - http://biorxiv.org/content/early/2020/04/25/2020.04.24.057323.full
AB  - Since emergence of SARS-CoV-2 in late 2019, there has been a critical need to understand prevalence, transmission patterns, to calculate the burden of disease and case fatality rates. Molecular diagnostics, the gold standard for identifying viremic cases, are not ideal for determining true case counts and rates of asymptomatic infection. Serological detection of SARS-CoV-2 specific antibodies can contribute to filling these knowledge gaps. In this study, we describe optimization and validation of a SARS-CoV-2-specific-enzyme linked immunosorbent assay (ELISA) using the prefusion-stabilized form of the spike protein [1]. We performed receiver operator characteristic (ROC) analyses to define the specificities and sensitivities of the optimized assay and examined cross reactivity with immune sera from persons confirmed to have had infections with other coronaviruses. These assays will be used to perform contact investigations and to conduct large-scale, cross sectional surveillance to define disease burden in the population.Competing Interest StatementThe authors have declared no competing interest.