Clinical characteristics and antibody response to SARS-CoV-2 spike 1 protein using VITROS Anti-SARS-CoV-2 antibody tests in COVID-19 patients in Japan

  1. Mayu Nagura-Ikeda
  2. Kazuo Imai
  3. Katsumi Kubota
  4. Sakiko Noguchi
  5. Yutaro Kitagawa
  6. Masaru Matsuoka
  7. Sakiko Tabata
  8. Kazuyasu Miyoshi
  9. Toshimitsu Ito
  10. Kaku Tamura
  11. Takuya Maeda

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Abstract

Introduction. Serological tests for COVID-19 are important in providing results for surveillance and supporting diagnosis. Investigating the serological response in COVID-19 patients with different disease severity is important for assessing the clinical utility of serological assays.

Gap Statement. However, few studies have investigated the clinical utility of antibody assays for COVID-19 or differences in antibody response in association with disease severity.

Aim. The study aimed to evaluate the clinical characteristics and clinical utility of VITROS SARS-CoV-2 antibody tests according to COVID-19 severity in patients in Japan.

Methodology. We analysed 255 serum specimens from 130 COVID-19 patients and examined clinical records and laboratory data. Presence of total (IgA, IgM, and IgG) and specific IgG antibody for the spike 1 antigen of SARS-CoV-2 was determined using VITROS Anti-SARS-CoV-2 antibody tests.

Results. Overall, 98 (75.4 %) and 32 (24.6 %) patients had mild and severe COVID-19, respectively. On admission, 76 (58.5 %) and 45 (34.6 %) patients were positive for total and IgG antibody assays. Among 91 patients at discharge, 90 (98.9 %) and 81 (89.0 %) were positive for total and IgG antibody, respectively. Clinical background and laboratory findings on admission, but not the prevalence or concentration of total or IgG antibody, were associated with disease prognosis. Total and IgG antibody intensities were significantly higher in severe cases than in mild cases in serum collected >11 days after onset, but not within 10 days.

Conclusion. VITROS Anti-SARS-CoV-2 total and IgG assays will be useful as supporting diagnostic and surveillance tools and for evaluation of humoral immune response to COVID-19. Optimal prediction of disease prognosis is made from considering both clinical history and laboratory findings.

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  1. Version published to 10.1099/jmm.0.001291 on Access Microbiology
  2. ScreenIT

    SciScore for 10.1101/2020.08.02.20166256: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementConsent: Written informed consent was obtained from enrolled patient.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Detection of antibodies for SARS-CoV-2: Total and IgG antibody assays against SARS-CoV-2 S proteins were performed using the VITROS Anti-SARS-CoV-2 Total Antibody Test and VITROS Anti-SARS-CoV-2 IgG Antibody Test (Ortho Clinical Diagnostics) according to the manufacturer’s instructions.
    IgG
    suggested: None
    Anti-SARS-CoV-2
    suggested: None
    Anti-SARS-CoV-2 IgG
    suggested: None

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    This study has some limitations. First, despite the confirmed high specificity of VITROS Anti-SARS-CoV-2 antibody assays [19, 20], specificity should be further analyzed using clinical specimens from non-COVID-19 patients. Also, recent reports showed a time-dependent decrease in antibody titer after the initial infection, especially in asymptomatic and mild cases [33]. Further studies are warranted to determine the utility of VITROS Anti-SARS-CoV-2 antibody assays as diagnostic and surveillance tools for COVID-19.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2020.08.02.20166256v1 on medRxiv