Antibodies to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in All of Us Research Program Participants, 2 January to 18 March 2020

Keri N. Althoff, David J. Schlueter, Hoda Anton-Culver, James Cherry, Joshua C. Denny, Isaac Thomsen, Elizabeth W. Karlson, Fiona P. Havers, Mine S. Cicek, Stephen N. Thibodeau, Ligia A. Pinto, Douglas Lowy, Bradley A. Malin, Lucila Ohno-Machado, Carolyn Williams, David Goldstein, Aymone Kouame, Andrea Ramirez, Adrienne Roman, Norman E. SharplessKelly A. Gebo, Sheri D. Schully

Research output: Contribution to journalArticlepeer-review


With 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 SARSCoV- 2 antibodies in the early weeks of the US epidemic. Methods. All 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 SARSCoV- 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). Results. The 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. Conclusions. Our findings identified SARS-CoV-2 infections weeks before the first recognized cases in 5 US states.

Original languageEnglish (US)
Pages (from-to)584-590
Number of pages7
JournalClinical Infectious Diseases
Issue number4
StatePublished - Feb 15 2022


  • All of Us Research Program
  • Epidemic
  • Immunoglobulin G antibodies
  • SARS-CoV-2
  • United States

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases


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