SARS-CoV-2-specific ELISA development

• DOI: 10.1016/j.jim.2020.112832
• Publication Date: 2020-08-08T10:51:15Z
• Authors: Vicky Roy; Stephanie Fischinger; Caroline Atyeo; Matthew Slein; Carolin Loos; Alejandro Balazs; Corinne Luedemann; Michael Gerino As...; Diane Yang; Duane R. Wesemann; Richelle Charles; A. John Lafrate; Jared Feldman; Blake Hauser; Tim Caradonna; Tyler E. Miller; Mandakolathur R. ...; Lindsey Baden; Eric Nilles; Edward Ryan; Douglas Lauffenbu...; Wilfredo Garcia B...; Galit Alter
• Keywords: 0303 health sciences; Time Factors; Clinical Laboratory Techniques; SARS-CoV-2; Immunology; Pneumonia, Viral; COVID-19; Reproducibility of Results; Enzyme-Linked Immunosorbent Assay; Antibodies, Viral; Sensitivity and Specificity; Article; High-Throughput Screening Assays; 3. Good health; Betacoronavirus; 03 medical and health sciences; COVID-19 Testing; Immunology and Allergy; Feasibility Studies; Humans; Coronavirus Infections; Pandemics

Critical to managing the spread of COVID-19 is the ability to diagnose infection and define the acquired immune response across the population. While genomic tests for the novel Several Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) detect the presence of viral RNA for a limited time frame, when the virus is shed in the upper respiratory tract, tests able to define exposure and infection beyond this short window of detectable viral replication are urgently needed. Following infection, antibodies are generated within days, providing a durable read-out and archive of exposure and infection. Several antibody tests have emerged to diagnose SARS-CoV-2. Here we report on a qualified quantitative ELISA assay that displays all the necessary characteristics for high-throughput sample analysis. Collectively, this test offers a quantitative opportunity to define both exposure and levels of immunity to SARS-CoV-2.