|Title:||Multicenter evaluation of two chemiluminescence and three lateral flow immunoassays for the diagnosis of COVID-19 and assessment of antibody dynamic responses to SARS-CoV-2 in Taiwan||Authors:||SHEY-YING CHEN
|Keywords:||COVID-19; antibody response; chemiluminescence immunoassays; cross-reactivity; lateral flow immunoassays||Issue Date:||Dec-2020||Publisher:||TAYLOR & FRANCIS LTD||Journal Volume:||9||Journal Issue:||1||Start page/Pages:||2157||Source:||Emerging microbes & infections||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.
autoantibody; 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; Taiwan
|Appears in Collections:||醫學院附設醫院 (臺大醫院)|
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.