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. Issue 1 (1st January 2020)

• Record Type: Journal Article
• Authors: Chen, Shey-Ying; Lee, Yu-Lin; Lin, Yi-Chun; Lee, Nan-Yao; Liao, Chia-Hung; Hung, Yuan-Pin; Lu, Min-Chi; Wu, Jhong-Lin; Tseng, Wen-Pin; Lin, Chien-Hao; Chung, Ming-Yi; Kang, Chun-Min; Lee, Ya-Fan; Lee, Tai-Fen; Cheng, Chien-Yu; Chen, Cheng-Pin; Huang, Chien-Hua; Liu, Chun-Eng; Cheng, Shu-Hsing; Ko, Wen-Chien; Hsueh, Po-Ren; Chen, Shyr-Chyr
• Is Part Of: Emerging microbes & infections. Volume 9:Issue 1(2020)
• Page Start: 2157
• Page End: 2168
• Publication Date: 2020-01-01
• Subjects: COVID-19 -- antibody response -- lateral flow immunoassays -- chemiluminescence immunoassays -- cross-reactivity; Medical microbiology -- Periodicals; Communicable diseases -- Periodicals; Infection -- Periodicals; 616.9041
• DOI: 10.1080/22221751.2020.1825016
• Languages: English
• ISSNs: 2222-1751

Abstract

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.