SHEY-YING CHENLee, Yu-LinYu-LinLeeLin, Yi-ChunYi-ChunLinLee, Nan-YaoNan-YaoLeeLiao, Chia-HungChia-HungLiaoHung, Yuan-PinYuan-PinHungLu, Min-ChiMin-ChiLuJHONG-LIN WUWEN-PIN TSENGCHIEN-HAO LINChung, Ming-YiMing-YiChungCHUN-MIN KANGLee, Ya-FanYa-FanLeeLee, Tai-FenTai-FenLeeCheng, Chien-YuChien-YuChengChen, Cheng-PinCheng-PinChenCHIEN-HUA HUANGLiu, Chun-EngChun-EngLiuCheng, Shu-HsingShu-HsingChengKo, Wen-ChienWen-ChienKoPO-REN HSUEHSHYR-CHYR CHEN2020-12-072020-12-072020-122222-1751https://scholars.lib.ntu.edu.tw/handle/123456789/524716This 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.enCOVID-19; antibody response; chemiluminescence immunoassays; cross-reactivity; lateral flow immunoassays[SDGs]SDG3autoantibody; immunoglobulin G; immunoglobulin M; SARS-CoV-2 antibody; virus antibody; adult; antibody blood level; antibody response; Article; chemiluminescence immunoassay; controlled study; coronavirus disease 2019; cross reaction; disease severity; early diagnosis; evaluation study; female; human; human tissue; immunoassay; lateral flow immunoassay; major clinical study; male; observational study; pneumonia; priority journal; retrospective study; seroconversion; serology; Severe acute respiratory syndrome coronavirus 2; Taiwan; aged; Betacoronavirus; blood; clinical trial; Coronavirus infection; genetics; immunoassay; immunology; luminescence; middle aged; multicenter study; pandemic; procedures; reproducibility; serology; severity of illness index; virology; virus pneumonia; Adult; Aged; Antibodies, Viral; Betacoronavirus; Coronavirus Infections; Cross Reactions; Female; Humans; Immunoassay; Luminescent Measurements; Male; Middle Aged; Pandemics; Pneumonia, Viral; Reproducibility of Results; Seroconversion; Serologic Tests; Severity of Illness Index; Taiwanjournal article10.1080/22221751.2020.182501632940547WOS:000576916300001