Abstract
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.
Keywords: All of Us Research Program; Epidemic; Immunoglobulin G antibodies; SARS-CoV-2; United States.
【저자키워드】 SARS-CoV-2, Epidemic, United States, All of Us Research Program, Immunoglobulin G antibodies, 【초록키워드】 IgG, coronavirus, antibody, SARS-COV-2 infection, ELISA, sensitivity, specificity, Immunoglobulin G, SARS-CoV-2 antibody, Immunoglobulin, Sensitivity and specificity, Algorithm, Travel, community transmission, United States, Massachusetts, Euroimmun, seropositive, SARS-CoV-2 IgG, Blood, Abbott, acute respiratory syndrome, 95% confidence interval, individual, specimen, participant, Architect, positive, the epidemic, enzyme-linked immunosorbent, tested, identify, the United State, provided, study participant, CIs, SARS-CoV-2 ELISA, study visit, symptomatic patient, 【제목키워드】 coronavirus 2, Program, respiratory,