Association of the Serum Levels of the Nucleocapsid Antigen of SARS-CoV-2 With the Diagnosis, Disease Severity, and Antibody Titers in Patients With COVID-19: A Retrospective Cross-Sectional Study

Several types of laboratory tests for COVID-19 have been established to date; however, the clinical significance of the serum SARS-CoV-2 nucleocapsid (N) antigen levels remains to be fully elucidated. In the present study, we attempted to elucidate the usefulness and clinical significance of the ser...

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Published inFrontiers in microbiology Vol. 12; p. 791489
Main Authors Yokoyama, Rin, Kurano, Makoto, Nakano, Yuki, Morita, Yoshifumi, Ohmiya, Hiroko, Kishi, Yoshiro, Okada, Jun, Qian, Chungen, Xia, Fuzhen, He, Fan, Zheng, Liang, Yu, Yi, Mizoguchi, Miyuki, Higurashi, Yoshimi, Harada, Sohei, Jubishi, Daisuke, Okamoto, Koh, Moriya, Kyoji, Kodama, Tatsuhiko, Yatomi, Yutaka
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LanguageEnglish
Published Switzerland Frontiers Media S.A 09.12.2021
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Abstract Several types of laboratory tests for COVID-19 have been established to date; however, the clinical significance of the serum SARS-CoV-2 nucleocapsid (N) antigen levels remains to be fully elucidated. In the present study, we attempted to elucidate the usefulness and clinical significance of the serum N antigen levels. We measured the serum N antigen levels in 391 serum samples collected from symptomatic patients with a confirmed diagnosis of COVID-19 and 96 serum samples collected from patients with non-COVID-19, using a fully automated chemiluminescence immunoassay analyzer. Receiver operating characteristic analysis identified the optimal cutoff value of the serum N antigen level (cutoff index, based on Youden's index) as 0.255, which yielded a sensitivity and specificity for the diagnosis of COVID-19 of 91.0 and 81.3%, respectively. The serum N antigen levels were significantly higher in the patient groups with moderate and severe COVID-19 than with mild disease. Moreover, a significant negative correlation was observed between the serum N antigen levels and the SARS-CoV-2 IgG antibody titers, especially in patients with severe COVID-19. Serum N antigen testing might be useful both for the diagnosis of COVID-19 and for obtaining a better understanding of the clinical features of the disease.
AbstractList Background: Several types of laboratory tests for COVID-19 have been established to date; however, the clinical significance of the serum SARS-CoV-2 nucleocapsid (N) antigen levels remains to be fully elucidated. In the present study, we attempted to elucidate the usefulness and clinical significance of the serum N antigen levels. Methods: We measured the serum N antigen levels in 391 serum samples collected from symptomatic patients with a confirmed diagnosis of COVID-19 and 96 serum samples collected from patients with non-COVID-19, using a fully automated chemiluminescence immunoassay analyzer. Results: Receiver operating characteristic analysis identified the optimal cutoff value of the serum N antigen level (cutoff index, based on Youden’s index) as 0.255, which yielded a sensitivity and specificity for the diagnosis of COVID-19 of 91.0 and 81.3%, respectively. The serum N antigen levels were significantly higher in the patient groups with moderate and severe COVID-19 than with mild disease. Moreover, a significant negative correlation was observed between the serum N antigen levels and the SARS-CoV-2 IgG antibody titers, especially in patients with severe COVID-19. Conclusion: Serum N antigen testing might be useful both for the diagnosis of COVID-19 and for obtaining a better understanding of the clinical features of the disease.
Background: Several types of laboratory tests for COVID-19 have been established to date; however, the clinical significance of the serum SARS-CoV-2 nucleocapsid (N) antigen levels remains to be fully elucidated. In the present study, we attempted to elucidate the usefulness and clinical significance of the serum N antigen levels.Methods: We measured the serum N antigen levels in 391 serum samples collected from symptomatic patients with a confirmed diagnosis of COVID-19 and 96 serum samples collected from patients with non-COVID-19, using a fully automated chemiluminescence immunoassay analyzer.Results: Receiver operating characteristic analysis identified the optimal cutoff value of the serum N antigen level (cutoff index, based on Youden’s index) as 0.255, which yielded a sensitivity and specificity for the diagnosis of COVID-19 of 91.0 and 81.3%, respectively. The serum N antigen levels were significantly higher in the patient groups with moderate and severe COVID-19 than with mild disease. Moreover, a significant negative correlation was observed between the serum N antigen levels and the SARS-CoV-2 IgG antibody titers, especially in patients with severe COVID-19.Conclusion: Serum N antigen testing might be useful both for the diagnosis of COVID-19 and for obtaining a better understanding of the clinical features of the disease.
Several types of laboratory tests for COVID-19 have been established to date; however, the clinical significance of the serum SARS-CoV-2 nucleocapsid (N) antigen levels remains to be fully elucidated. In the present study, we attempted to elucidate the usefulness and clinical significance of the serum N antigen levels. We measured the serum N antigen levels in 391 serum samples collected from symptomatic patients with a confirmed diagnosis of COVID-19 and 96 serum samples collected from patients with non-COVID-19, using a fully automated chemiluminescence immunoassay analyzer. Receiver operating characteristic analysis identified the optimal cutoff value of the serum N antigen level (cutoff index, based on Youden's index) as 0.255, which yielded a sensitivity and specificity for the diagnosis of COVID-19 of 91.0 and 81.3%, respectively. The serum N antigen levels were significantly higher in the patient groups with moderate and severe COVID-19 than with mild disease. Moreover, a significant negative correlation was observed between the serum N antigen levels and the SARS-CoV-2 IgG antibody titers, especially in patients with severe COVID-19. Serum N antigen testing might be useful both for the diagnosis of COVID-19 and for obtaining a better understanding of the clinical features of the disease.
Author Kurano, Makoto
Harada, Sohei
Yu, Yi
Ohmiya, Hiroko
Nakano, Yuki
Mizoguchi, Miyuki
Xia, Fuzhen
Okada, Jun
Jubishi, Daisuke
Yatomi, Yutaka
Okamoto, Koh
Kodama, Tatsuhiko
Morita, Yoshifumi
Qian, Chungen
He, Fan
Yokoyama, Rin
Higurashi, Yoshimi
Moriya, Kyoji
Zheng, Liang
Kishi, Yoshiro
AuthorAffiliation 2 Department of Clinical Laboratory Medicine, Graduate School of Medicine, The University of Tokyo , Tokyo , Japan
7 Laboratory for Systems Biology and Medicine, Research Center for Advanced Science and Technology, The University of Tokyo , Tokyo , Japan
5 Reagent R and D Center , Shenzhen YHLO Biotech Co., Ltd. , Guangdong , China
4 The Key Laboratory for Biomedical Photonics of MOE at Wuhan National Laboratory for Optoelectronics-Hubei Bioinformatics and Molecular Imaging Key Laboratory, Systems Biology Theme, Department of Biomedical Engineering, College of Life Science and Technology, Huazhong University of Science and Technology , Wuhan , China
6 Department of Infection Control and Prevention, The University of Tokyo , Tokyo , Japan
1 Department of Clinical Laboratory, The University of Tokyo Hospital , Tokyo , Japan
3 Sales and Marketing Division, Business Planning Department, Medical and Biological Laboratories Co., Ltd. , Tokyo , Japan
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  surname: Yatomi
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  organization: Department of Clinical Laboratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
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Copyright Copyright © 2021 Yokoyama, Kurano, Nakano, Morita, Ohmiya, Kishi, Okada, Qian, Xia, He, Zheng, Yu, Mizoguchi, Higurashi, Harada, Jubishi, Okamoto, Moriya, Kodama and Yatomi.
Copyright © 2021 Yokoyama, Kurano, Nakano, Morita, Ohmiya, Kishi, Okada, Qian, Xia, He, Zheng, Yu, Mizoguchi, Higurashi, Harada, Jubishi, Okamoto, Moriya, Kodama and Yatomi. 2021 Yokoyama, Kurano, Nakano, Morita, Ohmiya, Kishi, Okada, Qian, Xia, He, Zheng, Yu, Mizoguchi, Higurashi, Harada, Jubishi, Okamoto, Moriya, Kodama and Yatomi
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– notice: Copyright © 2021 Yokoyama, Kurano, Nakano, Morita, Ohmiya, Kishi, Okada, Qian, Xia, He, Zheng, Yu, Mizoguchi, Higurashi, Harada, Jubishi, Okamoto, Moriya, Kodama and Yatomi. 2021 Yokoyama, Kurano, Nakano, Morita, Ohmiya, Kishi, Okada, Qian, Xia, He, Zheng, Yu, Mizoguchi, Higurashi, Harada, Jubishi, Okamoto, Moriya, Kodama and Yatomi
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Keywords COVID-19
severity
antibody titer
nucleocapsid antigen
coronavirus disease 2019
N antigen
diagnosis
Language English
License Copyright © 2021 Yokoyama, Kurano, Nakano, Morita, Ohmiya, Kishi, Okada, Qian, Xia, He, Zheng, Yu, Mizoguchi, Higurashi, Harada, Jubishi, Okamoto, Moriya, Kodama and Yatomi.
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Edited by: Hirokazu Kimura, Graduate School of Health Science, Gunma Paz University, Japan
This article was submitted to Virology, a section of the journal Frontiers in Microbiology
Reviewed by: Patricia Merkel, University of Colorado, United StatesMaemu Gededzha, University of the Witwatersrand, South Africa
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Snippet Several types of laboratory tests for COVID-19 have been established to date; however, the clinical significance of the serum SARS-CoV-2 nucleocapsid (N)...
Background: Several types of laboratory tests for COVID-19 have been established to date; however, the clinical significance of the serum SARS-CoV-2...
Background: Several types of laboratory tests for COVID-19 have been established to date; however, the clinical significance of the serum SARS-CoV-2...
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StartPage 791489
SubjectTerms coronavirus disease 2019
COVID-19
diagnosis
Microbiology
N antigen
nucleocapsid antigen
severity
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Title Association of the Serum Levels of the Nucleocapsid Antigen of SARS-CoV-2 With the Diagnosis, Disease Severity, and Antibody Titers in Patients With COVID-19: A Retrospective Cross-Sectional Study
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