Validation of a SARS-CoV-2 spike ELISA for use in contact investigations and serosurveillance
Brandi Freeman; Sandra Lester; Lisa Mills; Mohammad Ata Ur Rasheed; Stefany Moye; Olubukola Abiona; Geoffrey Hutchinson; Maria Morales-Betoulle; Inna Krapinunaya; Ardith Gibbons; Cheng-Feng Chiang; Deborah Cannon; John Klena; Jeffrey A. Johnson; Sherry Michelle Owen; Barney S. Graham; Kizzmekia S. Corbett; Natalie J. Thornburg.
Preprint
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| PREPRINT-BIORXIV | ID: ppbiorxiv-057323
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.
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