Emerging Microbes and Infections (Jan 2020)

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

  • Shey-Ying Chen,
  • Yu-Lin Lee,
  • Yi-Chun Lin,
  • Nan-Yao Lee,
  • Chia-Hung Liao,
  • Yuan-Pin Hung,
  • Min-Chi Lu,
  • Jhong-Lin Wu,
  • Wen-Pin Tseng,
  • Chien-Hao Lin,
  • Ming-Yi Chung,
  • Chun-Min Kang,
  • Ya-Fan Lee,
  • Tai-Fen Lee,
  • Chien-Yu Cheng,
  • Cheng-Pin Chen,
  • Chien-Hua Huang,
  • Chun-Eng Liu,
  • Shu-Hsing Cheng,
  • Wen-Chien Ko,
  • Po-Ren Hsueh,
  • Shyr-Chyr Chen

DOI
https://doi.org/10.1080/22221751.2020.1825016
Journal volume & issue
Vol. 9, no. 1
pp. 2157 – 2168

Abstract

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ABSTRACTThis 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.

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