Validation and performance of a quantitative IgG assay for the screening of SARS-CoV-2 antibodies

• DOI: 10.1101/2020.06.11.146332
• Publication Date: 2020-06-13T09:45:20Z
• Authors: Ana M. Espino; Petraleigh Pantoja; Carlos A. Sariol
• Keywords: Convalescent plasma; Assay sensitivity

Abstract The current COVID-19 epidemic imposed an unpreceded challenge to the scientific community in terms of treatment, epidemiology, diagnosis, social interaction, fiscal policies and many other areas. development accurate reliable diagnostic tools (high specificity sensitivity) is crucial period, near future long term. These assays should provide guidance identify immune presumptive protected persons, potential plasma, and/or B cell donors vaccine among others. Also, such will be contributory supporting prospective retrospective studies prevalence incidence characterize dynamics response. As today, only thirteen serological have received Emergency Use Authorization (EUA) by U.S. Federal Drug Administration (FDA). In this work we describe validation a quantitative IgG enzyme-linked immunoassay (ELISA) using recombinant SARS-CoV-2 Spike Protein S1 domain, containing receptor-binding domain (RBD), showing 98% sensitivity, 98.9% positive negative predictive values 100% 99.2%, respectively. assay showed useful test for antibodies plasma samples from COVID-19-recovered subjects as plasmapheresis. This currently under review request (Submission Number EUA201115).