Correlation of the Commercial Anti-SARS-CoV-2 Receptor Binding Domain Antibody Test with the Chemiluminescent Reduction Neutralizing Test and Possible Detection of Antibodies to Emerging Variants

  1. Yoshitomo Morinaga
  2. Hideki Tani
  3. Yasushi Terasaki
  4. Satoshi Nomura
  5. Hitoshi Kawasuji
  6. Takahisa Shimada
  7. Emiko Igarashi
  8. Yumiko Saga
  9. Yoshihiro Yoshida
  10. Rei Yasukochi
  11. Makito Kaneda
  12. Yushi Murai
  13. Akitoshi Ueno
  14. Yuki Miyajima
  15. Yasutaka Fukui
  16. Kentaro Nagaoka
  17. Chikako Ono
  18. Yoshiharu Matsuura
  19. Takashi Fujimura
  20. Yoichi Ishida
  21. Kazunori Oishi
  22. Yoshihiro Yamamoto

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Abstract

This study provides a diagnostic evidence of test validity, which can lead to vaccine efficacy and proof of recovery after COVID-19. It is not easy to know neutralization against SARS-CoV-2 in the clinical laboratory because of technical and biohazard issues.

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  1. Version published to 10.1128/spectrum.00560-21
  2. ScreenIT

    SciScore for 10.1101/2021.05.25.21257828: (What is this?)

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

    Table 1: Rigor

    EthicsField Sample Permit: VeroE6/TMPRSS2 cells (JCRB1819) was purchased from Japanese Collection of Research Bioresources (JCRB) Cell Bank (Osaka, Japan).
    IRB: Ethics approval: This study was performed in accordance with the Declaration of Helsinki and was approved by the ethical review board of the University of Toyama (approval No.: R2019167 and R2020097).
    Consent: Written informed consent was obtained from all participants.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Experimental Models: Cell Lines
    SentencesResources
    In this study, we utilized VeroE6/TMPRSS2 cells, which were highly susceptible for SARS-CoV-2 infection.
    VeroE6/TMPRSS2
    suggested: JCRB Cat# JCRB1819, RRID:CVCL_YQ49)
    After incubation, Vero E6 TMPRSS2 cells were treated with DMEM-containing serum and pseudotyped virus.
    Vero E6 TMPRSS2
    suggested: JCRB Cat# JCRB1819, RRID:CVCL_YQ49)
    Recombinant DNA
    SentencesResources
    The expression plasmid for the truncated S protein of SARS-CoV-2, pCAG-SARS-CoV-2 S (Wuhan), were kindly provided from Dr. Shuetsu Fukushi, National Institute of Infectious Diseases, Japan.
    pCAG-SARS-CoV-2
    suggested: None
    The expression plasmids for the truncated mutant S protein of SARS-CoV-2, pCAGG-pm3-SARS2-Shu-d19-B1.1.7 (UK-derived variant) and pCAGG-pm3-SARS2-Shu-d19-B1.351 (South Africa-derived variant), were constructed by PCR-based site-directed mutagenesis using the cDNA as a template, which obtained by chemical synthesis with optimization for the humanized codon (Thermo Fisher Scientific, MA).
    pCAGG-pm3-SARS2-Shu-d19-B1.1.7
    suggested: None
    pCAGG-pm3-SARS2-Shu-d19-B1.351
    suggested: None
    The S cDNA of SARS-CoV-2 was cloned into the pCAGGS-pm3 expression vector.
    pCAGGS-pm3
    suggested: None
    Software and Algorithms
    SentencesResources
    Data were analyzed, using GraphPad Prism version 8.4.3 (GraphPad Software, CA).
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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:
    There are several limitations to the present study. First, serum samples in the present study were one-time collections. Therefore, the continuous antibody level trend and its relationship with disease severity could not be evaluated. Second, sera from individuals who had no evidence of infection, such as sera before the COVID-19 pandemic, could not be set as a control. Lastly, it is unknown whether cross-reactivity to variants is also observed in other commercial antibody tests. Because antigen-antibody relationships are specific, the test performance should be evaluated individually. The CRNT and anti-RBD antibody tests efficiently detect convalescent COVID-19 patients. Because most facilities cannot evaluate neutralizing antibodies, the good correlation of the non-functional antibody test with the CRNT may help assess the levels of functional antibodies in COVID-19 patients and vaccinated individuals.

    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.
    • Thank you for including a protocol registration statement.

    Results from scite Reference Check: We found no unreliable references.

    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 10.1101/2021.05.25.21257828v1 on medRxiv