Correlation of ELISA based with random access serologic immunoassays for identifying adaptive immune response to SARS-CoV-2

  1. Nguyen N. Nguyen
  2. Manohar B. Mutnal
  3. Richard R. Gomez
  4. Huy N. Pham
  5. Lam T. Nguyen
  6. William Koss
  7. Arundhati Rao
  8. Alejandro C. Arroliga
  9. Liping Wang
  10. Dapeng Wang
  11. Yinan Hua
  12. Priscilla R. Powell
  13. Li Chen
  14. Colin C. McCormack
  15. Walter J. Linz
  16. Amin A. Mohammad

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Abstract

Public health emergency of SARS-CoV-2 has facilitated diagnostic testing as a related medical countermeasure against COVID-19 outbreak. Numerous serologic antibody tests have become available through an expedited federal emergency use only process. This paper highlights the analytical characteristic of an ELISA based assay by AnshLabs and three random access immunoassay (RAIA) by DiaSorin, Roche, and Abbott that have been approved for emergency use authorization (EUA), at a tertiary academic center in a low disease-prevalence area. The AnshLabs gave higher estimates of sero-prevalence, over the three RAIA methods. For positive results, AnshLabs had 93.3% and 100% concordance with DiaSorin or Abbott and Roche respectively. For negative results, AnshLabs had 69.7% and 73.0% concordance with DiaSorin and Roche or Abbott respectively. All discrepant samples that were positive by AnshLabs and negative by RAIA tested positive by all-in-one step SARS-CoV-2 Total (COV2T) assay performed on the automated Siemens Advia Centaur XPT analyzer. None of these methods, however, are useful in early diagnosis of SARS-CoV-2.

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  1. ScreenIT

    SciScore for 10.1101/2020.07.06.20145938: (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
    The wells are washed and treated with the anti-human IgG antibodies conjugate labeled with peroxidase.
    anti-human IgG
    suggested: None
    The antibodies bind to the solid phase through the recombinant S1 and S2 antigens.
    S2
    suggested: None
    Samples with AU/mL of ≥15 are considered positive for IgG antibodies.
    IgG
    suggested: None
    The Elecsys Anti-SARS-CoV-2 assay is performed on the Roche cobas e601 analyzer for total antibodies specific for IgG, IgM and IgA which target nucleocapsid protein, in human serum or plasma.
    IgA which target nucleocapsid protein
    suggested: None
    Samples with COI ≥1.0 are considered reactive or positive for anti-SARS-COV-2 antibodies.
    anti-SARS-COV-2
    suggested: None
    Software and Algorithms
    SentencesResources
    The Abbott SARS-CoV-2 IgG assay was run on the Abbott Architect i2000SR analyzer that measures IgG antibodies to the nucleocapsid protein.
    Abbott Architect
    suggested: (Abbott ARCHITECT i1000sr System, RRID:SCR_019328)
    Statistical analysis: All test results were collated using a Microsoft Excel (Microsoft, Redmond, WA) spreadsheet.
    Microsoft Excel
    suggested: (Microsoft Excel, RRID:SCR_016137)
    Concordance was calculated using the macro formula in Excel.
    Excel
    suggested: None

    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:
    Project Limitations: Our quality assurance project has some notable limitations. At this stage of the disease, true clinical sensitivity and specificity for different methodologies is difficult to determine because of our limited understanding of the disease process and kinetics. Secondly, our assumption that ELISA has better limits of detection is based on circumstantial evidence, as certified standards quantifying limits of detection on different platforms are not available. Third, the cutoffs provided by manufacturers were relied on which may not have undergone extensive validation. Establishing laboratory specific cut-off is akin to establishing reference ranges, which is highly dependent on prevalence of disease in local population.

    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.

  2. Version published to 10.1101/2020.07.06.20145938v1 on medRxiv