Analytical performance of lateral flow immunoassay for SARS-CoV-2 exposure screening on venous and capillary blood samples

  1. Margaret A. Black
  2. Guomiao Shen
  3. Xiaojun Feng
  4. Wilfredo F. Garcia Beltran
  5. Yang Feng
  6. Varshini Vasudevaraja
  7. Douglas Allison
  8. Lawrence H. Lin
  9. Tatyana Gindin
  10. Michael Astudillo
  11. Diane Yang
  12. Mandakolathur Murali
  13. A. John Iafrate
  14. George Jour
  15. Paolo Cotzia
  16. Matija Snuderl

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Abstract

No abstract available

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  1. Version published to 10.1016/j.jim.2020.112909
  2. ScreenIT

    SciScore for 10.1101/2020.05.13.20098426: (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
    Study design: This retrospective study assessed the sensitivity and specificity of a commercially available lateral flow immunoassay for detection of IgM and IgG antibodies specific to SARS-CoV-2.
    IgG
    suggested: None
    SARS-CoV-2
    suggested: None
    Plasma, serum, and whole blood samples were tested for anti-SARS-CoV-2 IgM and IgG antibodies at D0 or D7, and capillary finger stick samples were obtained more than 14 days from both symptom onset (range, 19-61 days; median, 32 days) and PCR diagnosis (range, 18-46 days; median, 30.5 days)
    anti-SARS-CoV-2 IgM
    suggested: None
    IgG antibodies at D0 or D7
    suggested: None
    Enzyme-linked immunosorbent assay (ELISA): The MGH/Ragon COVID-19 IgG, IgA, and IgM ELISA, an in-house ELISA developed by Massachusetts General Hospital (Boston, MA) and Ragon Institute of MGH, MIT, and Harvard (Cambridge, MA), was performed on plasma and serum specimens for quantitative assessment of IgG, IgA, and IgM antibodies that target SARS-CoV-2 receptor binding domain (RBD).
    IgM
    suggested: None
    Quantitation of antibodies was performed by interpolating O.D. values to a standard curve consisting of an anti-SARS-CoV-1/2 monoclonal antibody (CR3022) in IgG, IgA, and IgM isotypes.
    anti-SARS-CoV-1/2
    suggested: None
    CR3022
    suggested: None
    Statistical Analysis: To compare Biolidics and ELISA in detecting antibodies at D0 and D7, a pair-wise two-sample t-test was conducted (Table 3).
    D7
    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: 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 10.1101/2020.05.13.20098426v1 on medRxiv