- 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;
- Program, on behalf of the All of Us Research
Background
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 SARS-CoV-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 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).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.