Longitudinal Evaluation of mRNA Vaccinated Subjects using a Quidel Multianalyte Point-of-Care SARS-CoV-2 IgG Immunoassay

  1. Xi Chen
  2. Sarika Agarwal
  3. Stewart Hoelscher
  4. Richard Egan
  5. Dipesh Jaiswal
  6. Adonis Stassinopoulos
  7. Robert Reed
  8. Jason McClure
  9. Werner Kroll

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Abstract

Infection from SARS-CoV-2 elicits an immune response to the nucleocapsid (N) and spike proteins (subunits S1 and S2). In this study, we set out to understand the utility of the multiplexed Quidel Sofia 2 SARS-CoV-2 IgG Antibody Fluorescent Immuno-Assay (FIA) that measures IgG antibodies against these three primary SARS-CoV-2 antigens from a single sample in 15 minutes. Using this assay with samples that were collected prior to the COVID-19 pandemic (n=816) and diseased state samples (n=99), the specificities for the three antigens were 98.4-99.9% and 98.0-100.0%, respectively. A longitudinal study was designed to collect weekly fingerstick, venous whole blood, serum and plasma samples from subjects vaccinated with the Moderna or Pfizer/BioNtech mRNA vaccines. The majority of these enrolled subjects had no known prior infection while a subset was known to have had prior COVID-19 infection. We found that the fingerstick whole blood samples performed as effectively as serum, plasma, and venous whole blood samples with a 95.8-99.5% agreement allowing physicians in a near-patient setting to rapidly provide results to their patients. Additionally, as this assay measures an IgG response against three viral proteins, S1, S2 and N, we were able to characterize immune response between i) naturally infected subjects, ii ) vaccinated subjects with no prior infection, iii ) vaccinated subjects with known prior infection, and iv ) vaccinated subjects with prior asymptomatic exposure/infection. The Quidel Sofia 2 SARS-CoV-2 IgG FIA will aid in providing insights to the protective humoral responses as an increasing number of the world population is vaccinated against SARS-CoV-2.

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  1. ScreenIT

    SciScore for 10.1101/2021.05.06.21256544: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Sofia 2 SARS-CoV-2 IgG Antibody FIA assay: The Sofia 2 SARS-CoV-2 IgG Antibody FIA is a single-use lateral flow rapid assay for the semi-quantitative detection of IgG antibodies to SARS-CoV-2 S1, S2 and N proteins.
    SARS-CoV-2
    suggested: None
    S1
    suggested: None
    The SARS-CoV-2 IgG antibodies present in the sample, bind to fluorescent beads containing anti-human IgG antibodies and subsequently bind to the immobilized S1, S2 and N antigens.
    SARS-CoV-2 IgG
    suggested: None
    anti-human IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    R version 4.03 and RStudio version 1.4.1106 were used for study data analysis.
    RStudio
    suggested: (RStudio, RRID:SCR_000432)
    Figures were generated using package ggplot2, version 3.3.3.
    ggplot2
    suggested: (ggplot2, RRID:SCR_014601)

    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.

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

    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 10.1101/2021.05.06.21256544v1 on medRxiv