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Multicenter Study
. 2020 Dec;9(1):2157-2168.
doi: 10.1080/22221751.2020.1825016.

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  1   2 , Yu-Lin Lee  3 , Yi-Chun Lin  4   5 , Nan-Yao Lee  6   7 , Chia-Hung Liao  8 , Yuan-Pin Hung  7   9   10 , Min-Chi Lu  11   12 , Jhong-Lin Wu  1 , Wen-Pin Tseng  1 , Chien-Hao Lin  1 , Ming-Yi Chung  13 , Chun-Min Kang  13   14 , Ya-Fan Lee  13 , Tai-Fen Lee  13 , Chien-Yu Cheng  4   15 , Cheng-Pin Chen  4   16 , Chien-Hua Huang  1 , Chun-Eng Liu  4 , Shu-Hsing Cheng  4   17 , Wen-Chien Ko  6   7 , Po-Ren Hsueh  13   18 , Shyr-Chyr Chen  1
Affiliations
Multicenter Study

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 et al. Emerg Microbes Infect. 2020 Dec.

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.

Keywords: COVID-19; antibody response; chemiluminescence immunoassays; cross-reactivity; lateral flow immunoassays.

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Conflict of interest statement

No potential conflict of interest was reported by the author(s).

Figures

Figure 1.
Figure 1.
Percentage of samples showing positive antibody findings when examined using the five studied serological tests after symptom onset.
Figure 2.
Figure 2.
Chemiluminescent signal values of the two chemiluminescence immunoassays for anti-SARS-CoV-2 antibodies detection after symptom onset. (A) Roche Elecsys® Anti-SARS-CoV-2 Assay. (B) Abbott SARS-CoV-2 IgG Assay.
Figure 3.
Figure 3.
Parallel comparisons of the cumulative probability of seroconversion detection among the five studied serological tests.
Figure 4.
Figure 4.
Detection of seroconversion in patients with COVID-19 with or without pneumonia. (A) Presumptive seroconversion based on earliest detection by any serological test. (B) Roche Elecsys® Anti-SARS-CoV-2 Assay. (C) Abbott SARS-CoV-2 IgG Assay.
Figure 5.
Figure 5.
Comparison of chemiluminescent signal values in patients with COVID-19 with or without pneumonia. (A) Roche Elecsys® Anti-SARS-CoV-2 Assay. (B) Abbott SARS-CoV-2 IgG Assay.
See this image and copyright information in PMC

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