![]() ![]() We included analyses of performance by time from symptom onset and disease severity. Specimens were obtained from patients with SARS-CoV-2 that was confirmed by RT–PCR, contemporaneous patients with other respiratory pathogen testing and/or without SARS-CoV-2 by RT–PCR and blood donor specimens collected before 2019. We conducted a head-to-head comparison of serology tests available to our group in early April, comprising ten immunochromatographic LFAs and two enzyme-linked immunosorbent assays (ELISAs) (for details, see Supplementary Table 1). Rigorous, comparative performance data are crucial to inform clinical care and public health responses. In response, dozens of companies began to market laboratory-based immunoassays and point-of-care (POC) tests. ![]() On February 4, 2020, the Secretary of the US Department of Health and Human Services issued an emergency use authorization (EUA) for the diagnosis of SARS-CoV-2 15, allowing nucleic acid detection and immunoassay tests to be offered based on manufacturer-reported data without formal US Food and Drug Administration (FDA) clearance 16. Widely available, reliable antibody detection assays would enable more accurate estimates of SARS-CoV-2 prevalence and incidence. The proportion of undocumented cases in the original epidemic focus was estimated to be as high as 86% 8, and asymptomatic infections are suspected to play a substantial role in transmission 9, 10, 11, 12, 13, 14. Individuals with positive molecular tests represent only a small fraction of all infections, given limited deployment and the brief time window when real-time (RT)–PCR testing has the highest sensitivity 5, 6, 7. Current testing for the virus largely depends on labor-intensive molecular techniques 4. Strategies to ease restraints on human mobility and interaction without provoking a major resurgence of transmission and mortality will depend on accurate estimates of population levels of infection and immunity 3. Government interventions to slow viral spread have disrupted daily life and economic activity for billions of people. Millions of infections by SARS-CoV-2, the virus responsible for COVID-19, have been reported, although its full extent has yet to be determined owing to limited testing 2. To date, hundreds of thousands of deaths have been attributed to coronavirus disease 2019 (COVID-19) 1. Although there was no standout serological assay, four tests achieved more than 80% positivity at later time points tested and more than 95% specificity. Our results underline the importance of seropositivity threshold determination and reader training for reliable LFA deployment. LFA specificity could be increased by considering weak bands as negative, but this decreased detection of antibodies (sensitivity) in a subset of SARS-CoV-2 real-time PCR-positive cases. Test specificity ranged from 84.3% to 100.0% and was predominantly affected by variability in IgM results. The percent of seropositive individuals increased with time, peaking in the latest time interval tested (>20 d after symptom onset). We conducted a head-to-head evaluation of ten point-of-care-style lateral flow assays (LFAs) and two laboratory-based enzyme-linked immunosorbent assays to detect anti-SARS-CoV-2 IgM and IgG antibodies in 5-d time intervals from symptom onset and studied the specificity of each assay in pre-coronavirus disease 2019 specimens. Nature Biotechnology volume 38, pages 1174–1183 ( 2020) Cite this articleĪppropriate use and interpretation of serological tests for assessments of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure, infection and potential immunity require accurate data on assay performance. ![]() Evaluation of SARS-CoV-2 serology assays reveals a range of test performance ![]()
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