Abstract
Serological assays are important tools to identify previous exposure to SARS-CoV-2, helping to track COVID-19 cases and determine the level of humoral response to SARS-CoV-2 infections and/or immunization to future vaccines. Here, the SARS-CoV-2 nucleocapsid protein was expressed in Escherichia coli and purified to homogeneity and high yield using a single chromatography step. The purified SARS-CoV-2 nucleocapsid protein was used to develop an indirect enzyme-linked immunosorbent assay for the identification of human SARS-CoV-2 seroconverts. The assay sensitivity and specificity were determined analyzing sera from 140 RT-qPCR-confirmed COVID-19 cases and 210 pre-pandemic controls. The assay operated with 90% sensitivity and 98% specificity; identical accuracies were obtained in head-to-head comparison with a commercial ELISA kit. Antigen-coated plates were stable for up to 3 months at 4 °C. The ELISA method described is ready for mass production and will be an additional tool to track COVID-19 cases.
Keywords: COVID-19; ELISA; Immunological test; Nucleocapsid protein; SARS-CoV-2.
【저자키워드】 COVID-19, SARS-CoV-2, ELISA, nucleocapsid protein, Immunological test, 【초록키워드】 SARS-CoV-2, Vaccines, SARS-COV-2 infection, immunization, ELISA, nucleocapsid protein, Protein, sensitivity, enzyme-linked immunosorbent assay, Humoral response, Accuracy, Sensitivity and specificity, serological assays, qPCR, sera, Head-to-head comparison, SARS-CoV-2 infections, Immunological test, COVID-19 cases, Escherichia coli, humoral, exposure to, mass production, head, COVID-19 case, homogeneity, ELISA kit, SARS-CoV-2 nucleocapsid, human SARS-CoV-2, helping, controls, enzyme-linked immunosorbent, described, identify, was used, develop, determine, expressed, purified, the SARS-CoV-2, 【제목키워드】 Seroconversion, human SARS-CoV-2, detect,