Clinical Evaluation of the Abbott Alinity SARS-CoV-2 Spike-Specific Quantitative IgG and IgM Assays among Infected, Recovered, and Vaccinated Groups

  1. Madhusudhanan Narasimhan
  2. Lenin Mahimainathan
  3. Ellen Araj
  4. Andrew E. Clark
  5. John Markantonis
  6. Allen Green
  7. Jing Xu
  8. Jeffrey A. SoRelle
  9. Charles Alexis
  10. Kimberly Fankhauser
  11. Hiren Parikh
  12. Kathleen Wilkinson
  13. Annika Reczek
  14. Noa Kopplin
  15. Sruthi Yekkaluri
  16. Jyoti Balani
  17. Abey Thomas
  18. Amit G. Singal
  19. Ravi Sarode
  20. Alagarraju Muthukumar

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Abstract

The coronavirus disease 19 (COVID-19) pandemic continues to impose a significant burden on global health infrastructure. While identification and containment of new cases remains important, laboratories must now pivot and consider an assessment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunity in the setting of the recent availability of multiple COVID-19 vaccines.

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  1. Version published to 10.1128/jcm.00388-21
  2. ScreenIT

    SciScore for 10.1101/2021.02.17.21251940: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: This study was approved by the Institutional Review Board of the University of Texas Southwestern Medical
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    The test is a chemiluminescent microparticle (CMIA) assay for semi-quantitative assessment of IgM antibodies to the spike protein of SARS-CoV-2 in human serum and plasma sample.
    IgM
    suggested: None
    In this antibody CMIA test, the SARS-CoV-2 antigen coated paramagnetic microparticles bind to the IgG antibodies that attach to the virus’ spike protein in human serum and plasma sample.
    IgG
    suggested: None
    Also, the samples that typically contain significant levels of antibodies such as lupus patients (n=29; collected between 2004-2007) positive for anti-nuclear antibodies (ANA) and anti-double stranded DNA, and hematological malignancies (HM) (n=66; collected between March and October 2020) were included.
    anti-nuclear
    suggested: None
    anti-double stranded DNA
    suggested: None
    Software and Algorithms
    SentencesResources
    IgGSP assay: SARS-CoV-2 IgG II quantitative testing (under FDA review) was performed on the Abbott Alinity i platform in accordance with manufacturer’s package insert.
    manufacturer’s
    suggested: (BioSpec TC-312 TC-312, RRID:SCR_019724)
    RT-PCR testing: The Abbott M2000 or Abbott Alinity M RT-PCR-based molecular testing/confirmation for SARS-CoV-2 was performed using nasopharyngeal specimens collected in viral transport media as previously described (5).
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    Statistical analysis: Data analysis was carried out using GraphPad Prism software (Version 9,0.1
    GraphPad Prism
    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: 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. Version published to 10.1101/2021.02.17.21251940v1 on medRxiv