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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.
Emerg Microbes Infect. 2020 Dec; 9(1):2157-2168.EM

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.

Authors+Show Affiliations

Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan. Center for Quality Management, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan.Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan.Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.Department of Internal Medicine and Center for Infection Control, College of Medicine, National Cheng Kung University Hospital, Tainan, Taiwan. Department of Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.Division of Infectious Diseases, Department of Internal Medicine, Ministry of Health and Welfare Nantou Hospital, Nantou, Taiwan.Department of Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Department of Internal Medicine, Tainan Hospital, Ministry of Health & Welfare, Tainan, Taiwan. Graduate Institute of Clinical Medicine, National Health Research Institutes, Tainan, Taiwan.Division of Infectious Diseases, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan. Department of Microbiology and Immunology, School of Medicine, China Medical University, Taichung, Taiwan.Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan. Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan.Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. School of Public Health, National Yang-Ming University, Taipei, Taiwan.Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. Institute of Clinical Medicine, National Yang-Ming University, Taipei, Taiwan.Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan. School of Public Health, Taipei Medical University, Taipei, Taiwan.Department of Internal Medicine and Center for Infection Control, College of Medicine, National Cheng Kung University Hospital, Tainan, Taiwan. Department of Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan. Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.Department of Emergency Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.

Pub Type(s)

Journal Article
Multicenter Study

Language

eng

PubMed ID

32940547

Citation

Chen, Shey-Ying, et al. "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." Emerging Microbes & Infections, vol. 9, no. 1, 2020, pp. 2157-2168.
Chen SY, Lee YL, Lin YC, et al. 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. Emerg Microbes Infect. 2020;9(1):2157-2168.
Chen, S. Y., Lee, Y. L., Lin, Y. C., Lee, N. Y., Liao, C. H., Hung, Y. P., Lu, M. C., Wu, J. L., Tseng, W. P., Lin, C. H., Chung, M. Y., Kang, C. M., Lee, Y. F., Lee, T. F., Cheng, C. Y., Chen, C. P., Huang, C. H., Liu, C. E., Cheng, S. H., ... Chen, S. C. (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. Emerging Microbes & Infections, 9(1), 2157-2168. https://doi.org/10.1080/22221751.2020.1825016
Chen SY, et al. 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. Emerg Microbes Infect. 2020;9(1):2157-2168. PubMed PMID: 32940547.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Chen,Shey-Ying, AU - Lee,Yu-Lin, AU - Lin,Yi-Chun, AU - Lee,Nan-Yao, AU - Liao,Chia-Hung, AU - Hung,Yuan-Pin, AU - Lu,Min-Chi, AU - Wu,Jhong-Lin, AU - Tseng,Wen-Pin, AU - Lin,Chien-Hao, AU - Chung,Ming-Yi, AU - Kang,Chun-Min, AU - Lee,Ya-Fan, AU - Lee,Tai-Fen, AU - Cheng,Chien-Yu, AU - Chen,Cheng-Pin, AU - Huang,Chien-Hua, AU - Liu,Chun-Eng, AU - Cheng,Shu-Hsing, AU - Ko,Wen-Chien, AU - Hsueh,Po-Ren, AU - Chen,Shyr-Chyr, PY - 2020/9/18/pubmed PY - 2020/10/10/medline PY - 2020/9/17/entrez KW - COVID-19 KW - antibody response KW - chemiluminescence immunoassays KW - cross-reactivity KW - lateral flow immunoassays SP - 2157 EP - 2168 JF - Emerging microbes & infections JO - Emerg Microbes Infect VL - 9 IS - 1 N2 - 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. SN - 2222-1751 UR - https://www.unboundmedicine.com/medline/citation/32940547/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_ DB - PRIME DP - Unbound Medicine ER -