Performance and validation of an adaptable multiplex assay for detection of serologic response to SARS-CoV-2 infection or vaccination

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Abstract

No abstract available

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  1. SciScore for 10.1101/2022.05.16.22275163: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Individuals provide written, informed consent for collection of demographic and clinical variables as well as blood for biobanking on up to 5 occasions every 6 months
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    The plate containing the samples and standard curves were then incubated for 30 minutes at room temperature, washed, following which MSD SULFO-TAG-labelled goat anti-human IgG secondary antibody was added at a concentration of 1ug/ml and the plate was further incubated for one hour.
    anti-human IgG
    suggested: None
    These kits comprise 96 well plates, precoated with antigens, proprietary blocker, diluent, wash buffer, detection antibody, read buffer, control sera and reference standard.
    antigens,
    suggested: None
    Software and Algorithms
    SentencesResources
    In addition, assay performance was compared with the Abbott SARS-CoV-2 IgG assay and the Abbott SARS-CoV-2 IgG II assay, chemiluminescent microparticle immunoassays (CMIA) (Abbott laboratories, IL, USA).
    Abbott
    suggested: (Abbott, RRID:SCR_010477)

    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:
    Although the CEPHR COVID19 Serology Assay has many advantages, it is not without limitations. The assay employs RBD derived from the Wuhan-Hu-1 reference strain of SARS-CoV-2. Although the test has been validated in convalescent plasma from individuals with confirmed SARS-CoV-2, these individuals were infected with the variants circulating in the first wave of infections in early 2020 and the performance of this assay against the different SARS-CoV-2 variants of concern (VOCs) that have emerged since is still under investigation. In addition, the vaccinated population was relatively small, with the majority of individuals less than 3 months from second dose vaccine. Given waning of post vaccine protection22, sensitivity of the assay may alter as time post vaccination increases. Additionally binding assays do not evaluate antibody function, such as neutralising capacity or antibody effector function, although these gold standard assays are time consuming and expensive and do not lend themselves to high throughput. However, correlation of the CEPHR COVID19 Serology Assay with these gold standard functional assays is ongoing. Despite these limitations, the CEPHR SARS-CoV-2 Serology Assay is a robust, customisable, multiplex serologic assay for the detection of several different IgG specific to SARS-CoV-2, with multiple potential real world applications and performance characteristics that support its further development for use in both research and clinical settings.

    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.