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
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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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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
Ethics Field 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 variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Cell Line Authentication not detected. Table 2: Resources
Experimental Models: Cell Lines Sentences Resources In this study, we utilized VeroE6/TMPRSS2 cells, which … 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
Ethics Field 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 variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Cell Line Authentication not detected. Table 2: Resources
Experimental Models: Cell Lines Sentences Resources In this study, we utilized VeroE6/TMPRSS2 cells, which were highly susceptible for SARS-CoV-2 infection. VeroE6/TMPRSS2suggested: JCRB Cat# JCRB1819, RRID:CVCL_YQ49)After incubation, Vero E6 TMPRSS2 cells were treated with DMEM-containing serum and pseudotyped virus. Vero E6 TMPRSS2suggested: JCRB Cat# JCRB1819, RRID:CVCL_YQ49)Recombinant DNA Sentences Resources 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-2suggested: NoneThe 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-B1.1.7suggested: NonepCAGG-pm3-SARS2-Shu-d19-B1.351suggested: NoneThe S cDNA of SARS-CoV-2 was cloned into the pCAGGS-pm3 expression vector. pCAGGS-pm3suggested: NoneSoftware and Algorithms Sentences Resources Data were analyzed, using GraphPad Prism version 8.4.3 (GraphPad Software, CA). GraphPad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)GraphPadsuggested: (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.
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