A high-throughput microsphere-based immunoassay of anti-SARS-CoV-2 IgM testing for COVID-19 diagnostics

  1. Dayu Zhang
  2. Tianyang Xu
  3. Eric Chu
  4. Aiguo Zhang
  5. Jinwei Du
  6. Michael Y. Sha

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Abstract

The pandemic of novel coronavirus disease COVID-19 is rapidly expanding across the world. A positive result of antibody tests suggests that the individual has potentially been exposed to SARS-CoV-2, thus allowing to identify asymptomatic infections and determine the seroprevalence in a given population. The aim of this study was to evaluate the performances of a newly developed high throughput immunoassay for anti-SARS-CoV-2 IgM antibody detection on the Luminex MAGPIX platform. Clinical agreement studies were performed in 42 COVID-19 patient serum samples and 162 negative donor serum/plasma samples. Positive percent agreement (PPA) was 42.86% (95% CI: 9.90% to 81.59%), 71.43% (95% CI: 29.04% to 96.33%), and 28.57% (95% CI: 13.22% to 48.67%) for samples collected on 0–7 days, 8–14 days, and 2–8 weeks from symptom onset, respectively. Negative Percent Agreement (NPA) was 97.53% (95% CI: 93.80% to 99.32%). There was no cross-reactivity with the SARS-CoV-2 IgG antibody. Hemoglobin (200 mg/dL), bilirubin (2 mg/dL), triglyceride (250 mg/dL) and EDTA (10 mM) showed no significant interfering effect on this assay. In conclusion, an anti-SARS-CoV-2 IgM antibody assay with high sensitivity and specificity has been developed. With the high throughput, this assay will speed up the anti-SARS-CoV-2 IgM testing.

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  1. Version published to 10.1371/journal.pone.0248444
  2. ScreenIT

    SciScore for 10.1101/2021.01.22.20249050: (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
    Anti-SARS-CoV-2 Spike RBD monoclonal antibody (IgM isotype) was purchased from Creative Diagnostics (Shirley, NY)
    Anti-SARS-CoV-2 Spike RBD
    suggested: None
    IgM isotype
    suggested: None
    PE conjugated anti-human IgM antibody was purchased from BioLegend (San Diego, CA)
    anti-human IgM
    suggested: None
    The IgM antibodies present in human specimens against S1 RBD protein (the antigen) will bind to the coated magnetic beads.
    IgM
    suggested: None
    S1 RBD protein ( the antigen )
    suggested: None
    The sample will be interpreted as positive when the ratio is ≥45; otherwise, the sample will be considered negative for Anti-SARS-CoV-2 IgM antibody.
    Anti-SARS-CoV-2 IgM
    suggested: None
    Software and Algorithms
    SentencesResources
    COVID-19 patient serum samples were acquired from ProMedDx (Norton, MA).
    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. Version published to 10.1101/2021.01.22.20249050v1 on medRxiv