1. Antibodies to SARS-CoV-2 in All of Us Research Program Participants, January 2-March 18, 2020
- Author
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Althoff, Keri N, Schlueter, David J, Anton-Culver, Hoda, Cherry, James, Denny, Joshua C, Thomsen, Isaac, Karlson, Elizabeth W, Havers, Fiona P, Cicek, Mine S, Thibodeau, Stephen N, Pinto, Ligia A, Lowy, Douglas, Malin, Bradley A, Ohno-Machado, Lucila, Williams, Carolyn, Goldstein, David, Kouame, Aymone, Ramirez, Andrea, Roman, Adrienne, Sharpless, Norman E, Gebo, Kelly A, Schully, Sheri D, and Program, on behalf of the All of Us Research
- Subjects
Infectious Diseases ,Emerging Infectious Diseases ,Lung ,Vaccine Related ,Biodefense ,Clinical Research ,Prevention ,Good Health and Well Being ,Antibodies ,Viral ,COVID-19 ,Enzyme-Linked Immunosorbent Assay ,Humans ,Immunoglobulin G ,Population Health ,SARS-CoV-2 ,Sensitivity and Specificity ,United States ,Epidemic ,Immunoglobulin G antibodies ,All of Us Research Program ,All of Us Research Program ,Biological Sciences ,Medical and Health Sciences ,Microbiology - Abstract
BackgroundWith limited severe acute respiratory syndrome coronavirus (SARS-CoV-2) testing capacity in the United States at the start of the epidemic (January-March 2020), testing was focused on symptomatic patients with a travel history throughout February, obscuring the picture of SARS-CoV-2 seeding and community transmission. We sought to identify individuals with SARS-CoV-2 antibodies in the early weeks of the US epidemic.MethodsAll of Us study participants in all 50 US states provided blood specimens during study visits from 2 January to 18 March 2020. Participants were considered seropositive if they tested positive for SARS-CoV-2 immunoglobulin G (IgG) antibodies with the Abbott Architect SARS-CoV-2 IgG enzyme-linked immunosorbent assay (ELISA) and the EUROIMMUN SARS-CoV-2 ELISA in a sequential testing algorithm. The sensitivity and specificity of these ELISAs and the net sensitivity and specificity of the sequential testing algorithm were estimated, along with 95% confidence intervals (CIs).ResultsThe estimated sensitivities of the Abbott and EUROIMMUN assays were 100% (107 of 107 [95% CI: 96.6%-100%]) and 90.7% (97 of 107 [83.5%-95.4%]), respectively, and the estimated specificities were 99.5% (995 of 1000 [98.8%-99.8%]) and 99.7% (997 of 1000 [99.1%-99.9%]), respectively. The net sensitivity and specificity of our sequential testing algorithm were 90.7% (97 of 107 [95% CI: 83.5%-95.4%]) and 100.0% (1000 of 1000 [99.6%-100%]), respectively. Of the 24 079 study participants with blood specimens from 2 January to 18 March 2020, 9 were seropositive, 7 before the first confirmed case in the states of Illinois, Massachusetts, Wisconsin, Pennsylvania, and Mississippi.ConclusionsOur findings identified SARS-CoV-2 infections weeks before the first recognized cases in 5 US states.
- Published
- 2022