ABSTRACT This multicenter, retrospective study included 346 serum samples from 74 patients with coronavirus disease 2019 (COVID-19) and 194 serum samples from non-COVID-19 patients to evaluate the performance of five anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody tests, i.e. two chemiluminescence immunoassays (CLIAs): Roche Elecsys® Anti-SARS-CoV-2 Test (Roche Test) and Abbott SARS-CoV-2 IgG (Abbott Test), and three lateral flow immunoassays (LFIAs): Wondfo SARS-CoV-2 Antibody Test (Wondfo Test), ASK COVID-19 IgG/IgM Rapid Test (ASK Test), and Dynamiker 2019-nCoV IgG/IgM Rapid Test (Dynamiker Test). We found high diagnostic sensitivities (%, 95% confidence interval [CI]) for the Roche Test (97.4%, 93.4–99.0%), Abbott Test (94.0%, 89.1–96.8%), Wondfo Test (91.4%, 85.8–94.9%), ASK Test (97.4%, 93.4–99.0%), and Dynamiker Test (90.1%, 84.3–94.0%) after >21 days of symptom onset. Meanwhile, the diagnostic specificity was 99.0% (95% CI, 96.3–99.7%) for the Roche Test, 97.9% (95% CI, 94.8–99.2%) for the Abbott Test, and 100.0% (95% CI, 98.1–100.0%) for the three LFIAs. Cross-reactivity was observed in sera containing anti-cytomegalovirus (CMV) IgG/IgM antibodies and autoantibodies. No difference was observed in the time to seroconversion detection of the five serological tests. Specimens from patients with COVID-19 pneumonia demonstrated a shorter seroconversion time and higher chemiluminescent signal than those without pneumonia. Our data suggested that understanding the dynamic antibody response after COVID-19 infection and performance characteristics of different serological test are crucial for the appropriate interpretation of serological test result for the diagnosis and risk assessment of patient with COVID-19 infection.
【저자키워드】 COVID-19, Antibody Response, cross-reactivity, Lateral flow immunoassays, chemiluminescence immunoassays, 【초록키워드】 coronavirus disease, serological test, SARS-CoV-2, coronavirus, Pneumonia, 2019-nCoV, Infection, Test, diagnostic, Diagnosis, risk, Retrospective study, lateral flow immunoassay, sensitivity, specificity, Seroconversion, Characteristics, COVID-19 infection, autoantibodies, antibody tests, chemiluminescence immunoassay, sera, Patient, Interpretation, Rapid, CMV, multicenter, Roche, serological, IgG/IgM antibody, Abbott, symptom onset, acute respiratory syndrome, 95% CI, 95% confidence interval, LFIAs, serum sample, Abbott SARS-CoV-2 IgG, patient with COVID-19, FIVE, seroconversion time, evaluate, demonstrated, suggested, non-COVID-19 patient, patients with COVID-19, 【제목키워드】 SARS-CoV-2, antibody, lateral flow immunoassay, response, Taiwan, chemiluminescence, diagnosis of COVID-19,