Analytical assessment of Beckman Coulter Access anti-SARS- CoV-2 IgG immunoassay

  1. Maurizio Ruscio
  2. Elisa D’Agnolo
  3. Anna Belgrano
  4. Mario Plebani
  5. Giuseppe Lippi

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Abstract

No abstract available

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  1. Version published to 10.21037/jlpm-20-105
  2. ScreenIT

    SciScore for 10.1101/2020.11.05.20226555: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: The entire investigation was based on pre-existing serum samples, collected for routine SARS-CoV-2 testing during a hospital seroprevalence study, and thereby no patient’s informed consent or Ethical Committee approval were necessary.
    IACUC: The entire investigation was based on pre-existing serum samples, collected for routine SARS-CoV-2 testing during a hospital seroprevalence study, and thereby no patient’s informed consent or Ethical Committee approval were necessary.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    An anti-human IgG alkaline phosphatase conjugate monoclonal antibody is then added, followed by second mixture separation by washing, for removing unbound conjugate material.
    anti-human IgG
    suggested: None
    Final results ≥1 are reported as being reactive for SARS-CoV-2 IgG antibodies, values between 0.8-1.0 as equivocal and those ≤0.80 as non-reactive for SARS-CoV-2 IgG antibodies.
    SARS-CoV-2 IgG
    suggested: None
    Method evaluation: The assessment of this novel Beckman Coulter Access SARS-CoV-2 IgG immunoassay on UniCel DxI800 has originally encompassed the calculation of intra-assay, inter-assay and total imprecision, linearity, limit of blank (LOB), limit of detection (LOD), functional sensitivity, as well as comparison of anti-SARS-CoV-2 antibodies values obtained on paired serum samples using two other commercial anti-SARS-CoV-2 immunoassays, as comprehensively described below.
    anti-SARS-CoV-2
    suggested: None
    The results of Access SARS-CoV-2 IgG were then compared with those obtained on paired serum samples using DiaSorin Liaison SARS-CoV-2 S1/S2 IgG and Roche Elecsys Anti-SARS-CoV-2 total antibodies.
    Anti-SARS-CoV-2 total antibodies .
    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 10.1101/2020.11.05.20226555v1 on medRxiv