A high-throughput Anti-SARS-CoV-2 IgG testing platform for COVID-19

  1. Jinwei Du
  2. Eric Chu
  3. Dayu Zhang
  4. Chuanyi M. Lu
  5. Aiguo Zhang
  6. Michael Y. Sha

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Abstract

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  1. Version published to 10.1016/j.jviromet.2020.114009
  2. ScreenIT

    SciScore for 10.1101/2020.07.23.20160804: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    SARS-CoV-2 Spike S1 Antibody (human chimeric, IgG isotype) was purchased from GenScript Biotech Corporation (Piscataway, NJ).
    human chimeric , IgG isotype
    suggested: None
    human chimeric , IgG
    suggested: None
    Spike RBD monoclonal antibody (IgM isotype) was purchased from Creative Diagnostics (Shirley, NY)
    IgM isotype
    suggested: None
    PE conjugated anti-human IgG Fc antibody was purchased from BioLegend (San Diego, CA)
    anti-human IgG
    suggested: None
    Patient serum samples positive for IgG to HBV/HCV/HIV/RSV were purchased from Antibody Systems, Inc (Hurst, TX).
    HBV/HCV/HIV/RSV
    suggested: None
    The IgG antibodies present in human specimens against S1 RBD protein (the antigen) will bind the coated magnetic beads.
    IgG
    suggested: None
    S1 RBD protein ( the antigen )
    suggested: None
    Class specificity was evaluated by spiking anti-SARS-CoV-2 RBD antibody IgG isotype and IgM isotype into a negative serum sample, respectively.
    anti-SARS-CoV-2 RBD antibody IgG isotype and IgM
    suggested: None
    Software and Algorithms
    SentencesResources
    COVID-19 patient serum samples were acquired from ProMedDx (Norton, MA) and University of California and VA Healthcare System.
    ProMedDx
    suggested: (ProMedDx, RRID:SCR_010542)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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. ScreenIT

    SciScore for 10.1101/2020.07.23.20160804: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.Randomizationnot detected.Blindingnot detected.Power Analysisnot detected.Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    SARS-CoV-2 Spike S1 Antibody (human chimeric, IgG isotype) was purchased from GenScript Biotech Corporation (Piscataway, NJ).
    human chimeric , IgG isotype
    suggested: None
    human chimeric , IgG
    suggested: None
    Spike RBD monoclonal antibody (IgM isotype) was purchased from Creative Diagnostics (Shirley, NY)
    IgM isotype
    suggested: None
    Patient serum samples positive for IgG to HBV/HCV/HIV/RSV were purchased from Antibody Systems, Inc (Hurst, TX).
    HBV/HCV/HIV/RSV
    suggested: None
    The IgG antibodies present in human specimens against S1 RBD protein (the antigen) will bind the coated magnetic beads.
    IgG
    suggested: None
    S1 RBD protein ( the antigen )
    suggested: None
    After washing, PE conjugated anti-human IgG antibody was added to the reaction mixture and incubated at room temperature for 0.5 hour.
    anti-human IgG
    suggested: None
    Class specificity was evaluated by spiking anti-SARS-CoV-2 RBD antibody IgG isotype and IgM isotype into a negative serum sample, respectively.
    anti-SARS-CoV-2 RBD antibody IgG isotype and IgM
    suggested: None
    The human anti-SARS-CoV-2 Spike RBD antibody (IgG and IgM isotypes) was spiked into a negative serum sample respectively, and then tested by QuantiVirusTM Anti-SARS-CoV-2 IgG Test.
    anti-SARS-CoV-2 Spike RBD antibody (IgG
    suggested: None
    Anti-SARS-CoV-2 IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    COVID-19 patient serum samples were acquired from ProMedDx (Norton, MA) and University of California and VA Healthcare System.
    ProMedDx
    suggested: (ProMedDx, RRID:SCR_010542)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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.

    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 is not a substitute for expert review. SciScore checks for the presence and correctness of RRIDs (research resource identifiers) in the manuscript, and detects sentences that appear to be missing RRIDs. SciScore also checks to make sure that rigor criteria are addressed by authors. It does this by detecting sentences that discuss criteria such as blinding or power analysis. SciScore does not guarantee that the rigor criteria that it detects are appropriate for the particular study. Instead it assists authors, editors, and reviewers by drawing attention to sections of the manuscript that contain or should contain various rigor criteria and key resources. For details on the results shown here, including references cited, please follow this link.

  4. ScreenIT

    SciScore for 10.1101/2020.07.23.20160804: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.Randomizationnot detected.Blindingnot detected.Power Analysisnot detected.Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Herein, we reported the performance evaluation of the QuantiVirus™ anti-SARS-CoV-2 IgG test which is a two-step immunoassay using Luminex platform to detect anti-SARS-CoV-2 spike protein 1 (S1) receptor-binding domain (RBD) IgG antibody in human serum or plasma specimens.
    anti-SARS-CoV-2 spike protein 1 (S1) receptor-binding domain (RBD) IgG
    suggested: None
    SARS-CoV-2 Spike S1 Antibody (human chimeric, IgG isotype) was purchased from GenScript Biotech Corporation (Piscataway, NJ).
    human chimeric , IgG isotype
    suggested: None
          <div style="margin-bottom:8px">
        <div><b>human chimeric , IgG</b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">Spike RBD monoclonal antibody (IgM isotype) was purchased from Creative Diagnostics (Shirley, NY)</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>IgM isotype </b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">Patient serum samples positive for IgG to HBV/HCV/HIV/RSV were purchased from Antibody Systems, Inc (Hurst, TX).</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>HBV/HCV/HIV/RSV</b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">The IgG antibodies present in human specimens against S1 RBD protein (the antigen) will bind the coated magnetic beads.</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>S1 RBD protein ( the antigen )</b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">Cross-reactivity was evaluated using serum or plasma samples which are positive for IgG antibodies to the following pathogens: HIV, HAV, HBV, RSV, CMV EBV, Rubella, Influenza A, and Influenza B.</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>IgG</b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">Class specificity was evaluated by spiking anti-SARS-CoV-2 RBD antibody IgG isotype and IgM isotype into a negative serum sample, respectively.</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>anti-SARS-CoV-2 RBD antibody IgG isotype and IgM</b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">3.3 Cross-reactivity Cross-reactivity of the QuantiVirusTM Anti-SARS-CoV-2 IgG Test was evaluated by using serum or plasma samples which are positive for IgG antibodies to the pathogens such as Influenza A or B (listed in Table 3).</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>Anti-SARS-CoV-2 IgG</b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">The human anti-SARS-CoV-2 Spike RBD antibody (IgG and IgM isotypes) was spiked into a negative serum sample respectively, and then tested by QuantiVirusTM Anti-SARS-CoV-2 IgG Test.</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>anti-SARS-CoV-2 Spike RBD antibody ( IgG</b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">A strong binding was observed for IgG isotype while no binding interaction was observed between the anti-human IgG antibody used in the QuantiVirusTM Anti-SARS-CoV-2 IgG Test and human IgM isotype, demonstrating class-specific reactivity only to human IgG isotype (Table 4).</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>anti-human IgG</b></div>
        <div>suggested: None</div>
      </div>
    
      <div style="margin-bottom:8px">
        <div><b>human IgM</b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">Hettegger et al demonstrated that IgG profiles in plasma and saliva are highly similar for each individual and found the anti-HBV IgG antibody from saliva (14).</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>anti-HBV IgG</b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">Previous other virus studies suggested that serum heat inactivation and optimal dilution enhance WNV E-MIA sensitivity by eliminating the complement interference, thereby detecting low-titer anti-WNV antibodies during early and late phases of infection (15).</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>anti-WNV</b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">However, heat-inactivation cannot be used in fluorescence immunochromatography for SARS-CoV-2 antibody detection because negative samples became positive after heat-inactivation (16), which is consistent with our results that heat-inactivation significantly increased the MFI for all the samples tested and the negative plasma sample became false positive.</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>SARS-CoV-2</b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;text-align:center; padding-top:4px;" colspan="2"><b>Software and Algorithms</b></td></tr><tr><td style="min-width:100px;text=align:center"><i>Sentences</i></td><td style="min-width:100px;text-align:center"><i>Resources</i></td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">Patient serum samples positive for IgG to HAV/CMV/EBV/Rubella/Influenza B were purchased from ProMedDx (Norton, MA).</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>ProMedDx</b></div>
        <div>suggested: (ProMedDx, <a href="https://scicrunch.org/resources/Any/search?q=SCR_010542">SCR_010542</a>)</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">Recently, Cochrane Infectious Diseases Group assessed the diagnostic accuracy of anti-SARS-CoV-2 antibody tests using the Cochrane COVID-19 Study Register and the COVID-19 Living Evidence Database from the University of Bern (11).</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>Cochrane Infectious</b></div>
        <div>suggested: None</div>
      </div>
    </td></tr><tr><td style="min-width:100px;vertical-align:top;border-bottom:1px solid lightgray">FDA EUA approved Abbott SARS-CoV-2 IgG test on Abbott Architect platform reportedly has 100% sensitivity after 17 days from onset of symptoms and 100% specificity (13).</td><td style="min-width:100px;border-bottom:1px solid lightgray">
      <div style="margin-bottom:8px">
        <div><b>Abbott Architect</b></div>
        <div>suggested: (Abbott ARCHITECT i1000sr System, <a href="https://scicrunch.org/resources/Any/search?q=SCR_018371">SCR_018371</a>)</div>
      </div>
    </td></tr></table>

    Data from additional tools added to each annotation on a weekly basis.

    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 is not a substitute for expert review. SciScore checks for the presence and correctness of RRIDs (research resource identifiers) in the manuscript, and detects sentences that appear to be missing RRIDs. SciScore also checks to make sure that rigor criteria are addressed by authors. It does this by detecting sentences that discuss criteria such as blinding or power analysis. SciScore does not guarantee that the rigor criteria that it detects are appropriate for the particular study. Instead it assists authors, editors, and reviewers by drawing attention to sections of the manuscript that contain or should contain various rigor criteria and key resources. For details on the results shown here, including references cited, please follow this link.

  5. Version published to 10.1101/2020.07.23.20160804v1 on medRxiv