Anti-SARS-CoV-2 Antibody Levels Measured by the AdviseDx SARS-CoV-2 Assay Are Concordant with Previously Available Serologic Assays but Are Not Fully Predictive of Sterilizing Immunity

  1. Benjamin T. Bradley
  2. Andrew Bryan
  3. Susan L. Fink
  4. Erin A. Goecker
  5. Pavitra Roychoudhury
  6. Meei-Li Huang
  7. Haiying Zhu
  8. Anu Chaudhary
  9. Bhanupriya Madarampalli
  10. Joyce Y. C. Lu
  11. Kathy Strand
  12. Estella Whimbey
  13. Chloe Bryson-Cahn
  14. Adrienne Schippers
  15. Nandita S. Mani
  16. Gregory Pepper
  17. Keith R. Jerome
  18. Chihiro Morishima
  19. Robert W. Coombs
  20. Mark Wener
  21. Seth Cohen
  22. Alexander L. Greninger

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Abstract

With the availability of widespread SARS-CoV-2 vaccination, high-throughput quantitative antispike serological testing will likely become increasingly important. Here, we investigated the performance characteristics of the recently FDA-authorized semiquantitative antispike AdviseDx SARS-CoV-2 IgG II assay compared to the FDA-authorized antinucleocapsid Abbott Architect SARS-CoV-2 IgG, Roche Elecsys anti-SARS-CoV-2-S, EuroImmun anti-SARS-CoV-2 enzyme-linked immunosorbent assay (ELISA), and GenScript surrogate virus neutralization assays and examined the humoral response associated with vaccination, natural protection, and breakthrough infection.

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  1. Version published to 10.1128/jcm.00989-21
  2. ScreenIT

    SciScore for 10.1101/2021.04.26.21256118: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: This study was approved by the University of Washington Institutional Review Board.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Study population & Specimen collection: A total of 128 residual plasma specimens from 91 patients with a history of PCR-confirmed SARS-CoV-2 infection or anti-N IgG antibodies were included in this study (raw data in Supplemental Dataset 1).
    anti-N IgG
    suggested: None
    Anti-N Abbott Architect SARS-CoV-2 IgG and Anti-S AdviseDx SARS-CoV-2 IgG II assays: The emergency use authorized anti-N Architect SARS-CoV-2 IgG and anti-S AdviseDx SARS-CoV-2 IgG II assays (Abbott, Chicago, IL) are chemiluminescent microparticle immunoassay (CIMA) designed to measure IgG antibodies binding the N protein and S protein, respectively, and were performed on an Architect i2000SR.
    Anti-N Abbott Architect SARS-CoV-2 IgG
    suggested: None
    Anti-S AdviseDx SARS-CoV-2 IgG
    suggested: None
    anti-N Architect SARS-CoV-2 IgG
    suggested: None
    anti-S
    suggested: None
    measure IgG
    suggested: None
    EuroImmun Anti-SARS-CoV-2 ELISA: The EuroImmun anti-SARS-CoV-2 IgG assay is a semi-quantitative ELISA detecting antibodies which bind the S1 subunit of the spike protein.
    anti-SARS-CoV-2 IgG
    suggested: None
    After two minutes of incubation, luminescence was measured on the VICTOR Nivo and IC50 was calculated from a standard curve using the CV30 monoclonal antibody (Absolute Antibody, Oxford, UK).
    CV30
    suggested: None
    Preparation of the International Standard: The WHO First International Standard for SARS-CoV-2 antibody were prepared according to the manufacturer’s instructions (21).
    SARS-CoV-2
    suggested: None
    Experimental Models: Cell Lines
    SentencesResources
    SARS-CoV-2 Spike Pseudotyped Lentivirus Neutralization assay: 1.25E4 293T-ACE2 cells were seeded in 96-well plates and incubated in DMEM + 10% FBS for 16-18 hrs.
    293T-ACE2
    suggested: RRID:CVCL_YZ65)
    Software and Algorithms
    SentencesResources
    SARS-CoV-2 Whole genome sequencing was performed using the Swift Biosciences v2 or Illumina COVID-Seq amplicon tiling assays (19).
    Swift Biosciences
    suggested: None
    Anti-N Abbott Architect SARS-CoV-2 IgG and Anti-S AdviseDx SARS-CoV-2 IgG II assays: The emergency use authorized anti-N Architect SARS-CoV-2 IgG and anti-S AdviseDx SARS-CoV-2 IgG II assays (Abbott, Chicago, IL) are chemiluminescent microparticle immunoassay (CIMA) designed to measure IgG antibodies binding the N protein and S protein, respectively, and were performed on an Architect i2000SR.
    Abbott
    suggested: (Abbott, RRID:SCR_010477)
    The index value of 1.40 or greater was classified as positive per manufacturer’s recommendation for the anti-N Abbott Abbott Architect SARS-CoV-2 IgG assay.
    Abbott Architect
    suggested: (Abbott ARCHITECT i1000sr System, RRID:SCR_019328)
    Assay performance, linear regression, curve fitting calculations were performed using Prism 9 (GraphPad Software, LLC, San Diego, CA, USA).
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)

    Results from OddPub: Thank you for sharing your data.

    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.

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

    About SciScore

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  3. Version published to 10.1101/2021.04.26.21256118v1 on medRxiv