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 in | Frontiers in microbiology Vol. 12; p. 791489 |
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Main Authors | , , , , , , , , , , , , , , , , , , , |
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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. |
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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 |
AuthorAffiliation_xml | – name: 6 Department of Infection Control and Prevention, The University of Tokyo , Tokyo , Japan – name: 2 Department of Clinical Laboratory Medicine, Graduate School of Medicine, The University of Tokyo , Tokyo , Japan – name: 7 Laboratory for Systems Biology and Medicine, Research Center for Advanced Science and Technology, The University of Tokyo , Tokyo , Japan – name: 5 Reagent R and D Center , Shenzhen YHLO Biotech Co., Ltd. , Guangdong , China – name: 1 Department of Clinical Laboratory, The University of Tokyo Hospital , Tokyo , Japan – name: 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 – name: 3 Sales and Marketing Division, Business Planning Department, Medical and Biological Laboratories Co., Ltd. , Tokyo , Japan |
Author_xml | – sequence: 1 givenname: Rin surname: Yokoyama fullname: Yokoyama, Rin organization: Department of Clinical Laboratory, The University of Tokyo Hospital, Tokyo, Japan – sequence: 2 givenname: Makoto surname: Kurano fullname: Kurano, Makoto organization: Department of Clinical Laboratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan – sequence: 3 givenname: Yuki surname: Nakano fullname: Nakano, Yuki organization: Department of Clinical Laboratory, The University of Tokyo Hospital, Tokyo, Japan – sequence: 4 givenname: Yoshifumi surname: Morita fullname: Morita, Yoshifumi organization: Department of Clinical Laboratory, The University of Tokyo Hospital, Tokyo, Japan – sequence: 5 givenname: Hiroko surname: Ohmiya fullname: Ohmiya, Hiroko organization: Sales and Marketing Division, Business Planning Department, Medical and Biological Laboratories Co., Ltd., Tokyo, Japan – sequence: 6 givenname: Yoshiro surname: Kishi fullname: Kishi, Yoshiro organization: Sales and Marketing Division, Business Planning Department, Medical and Biological Laboratories Co., Ltd., Tokyo, Japan – sequence: 7 givenname: Jun surname: Okada fullname: Okada, Jun organization: Sales and Marketing Division, Business Planning Department, Medical and Biological Laboratories Co., Ltd., Tokyo, Japan – sequence: 8 givenname: Chungen surname: Qian fullname: Qian, Chungen organization: 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 – sequence: 9 givenname: Fuzhen surname: Xia fullname: Xia, Fuzhen organization: Reagent R and D Center, Shenzhen YHLO Biotech Co., Ltd., Guangdong, China – sequence: 10 givenname: Fan surname: He fullname: He, Fan organization: Reagent R and D Center, Shenzhen YHLO Biotech Co., Ltd., Guangdong, China – sequence: 11 givenname: Liang surname: Zheng fullname: Zheng, Liang organization: Reagent R and D Center, Shenzhen YHLO Biotech Co., Ltd., Guangdong, China – sequence: 12 givenname: Yi surname: Yu fullname: Yu, Yi organization: Reagent R and D Center, Shenzhen YHLO Biotech Co., Ltd., Guangdong, China – sequence: 13 givenname: Miyuki surname: Mizoguchi fullname: Mizoguchi, Miyuki organization: Department of Infection Control and Prevention, The University of Tokyo, Tokyo, Japan – sequence: 14 givenname: Yoshimi surname: Higurashi fullname: Higurashi, Yoshimi organization: Department of Infection Control and Prevention, The University of Tokyo, Tokyo, Japan – sequence: 15 givenname: Sohei surname: Harada fullname: Harada, Sohei organization: Department of Infection Control and Prevention, The University of Tokyo, Tokyo, Japan – sequence: 16 givenname: Daisuke surname: Jubishi fullname: Jubishi, Daisuke organization: Department of Infection Control and Prevention, The University of Tokyo, Tokyo, Japan – sequence: 17 givenname: Koh surname: Okamoto fullname: Okamoto, Koh organization: Department of Infection Control and Prevention, The University of Tokyo, Tokyo, Japan – sequence: 18 givenname: Kyoji surname: Moriya fullname: Moriya, Kyoji organization: Department of Infection Control and Prevention, The University of Tokyo, Tokyo, Japan – sequence: 19 givenname: Tatsuhiko surname: Kodama fullname: Kodama, Tatsuhiko organization: Laboratory for Systems Biology and Medicine, Research Center for Advanced Science and Technology, The University of Tokyo, Tokyo, Japan – sequence: 20 givenname: Yutaka surname: Yatomi fullname: Yatomi, Yutaka organization: Department of Clinical Laboratory Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan |
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Keywords | COVID-19 severity antibody titer nucleocapsid antigen coronavirus disease 2019 N antigen diagnosis |
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Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 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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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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