Clinical performance evaluation of a SARS-CoV-2 Rapid Antibody Test for determining past exposure to SARS-CoV-2

  1. Peter Findeisen
  2. Hugo Stiegler
  3. Eloisa Lopez-Calle
  4. Tanja Schneider
  5. Eva Urlaub
  6. Johannes Hayer
  7. Claudia Zemmrich

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Abstract

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  1. ScreenIT

    SciScore for 10.1101/2020.09.01.20180687: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: For the samples tested at Roche Diagnostics, a statement was obtained from the Ethics Committee of the Landesärztekammer Bayern confirming that there are no objections against the transfer and the coherent use of the anonymized leftover samples.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Monoclonal chicken IgY antibody is coated on the “C” region, and monoclonal anti-human IgG antibody and monoclonal anti-human IgM antibody are coated on the “G” and “M” test line region.
    anti-human IgG
    suggested: None
    anti-human IgM
    suggested: None
    During the test, SARS-CoV-2-specific antibodies in the sample interact with recombinant SARS-CoV-2 protein (nucleocapsid and spike protein) conjugated with colloidal gold particles forming antibody-antigen gold particle complexes.
    SARS-CoV-2-specific
    suggested: None
    All samples were analyzed with the Anti-SARS-CoV-2 Rapid Antibody Assay and results were compared directly with the EDTA plasma sample from the Elecsys Anti-SARS-CoV-2 Assay (see Figure 1 for workflow).
    Anti-SARS-CoV-2
    suggested: None
    Software and Algorithms
    SentencesResources
    Data availability: Qualified researchers may request access to individual patient level data through the clinical study data request platform (https://vivli.org/).
    https://vivli.org/
    suggested: (Vivli, RRID:SCR_018080)

    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:
    A limitation of this study is that samples were not differentiated according to time of collection after symptom onset, as such some of the false positive samples might actually be true positives, but were not detected by the Elecsys assay and most likely indicate an early antibody response with low affinity antibodies. For SARS-CoV-2 tests high specificity is a priority, particularly in low prevalence settings (30), as such it would be interesting to further evaluate the interpretation of the low positive samples at the rapid test, particularly for samples that were IgM positive only, to determine if these reflect non-specific binding, or true early detection. Further assessment with serial samples taken from COVID-19 patients from early infection phase onwards will help to better understand this. The investigated Anti-SARS-CoV-2 Rapid Antibody Test provided readily evaluable results, regardless of sample type (whole blood or EDTA plasma) and independent of any read-out time between 10 and 15 minutes, as stated in the instructions for use. Those positive practical aspects could enable potential use outside medical environments. The assay is currently intended for professional use in laboratory and PoC environments as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating prior infection. In these studies, the SARS-CoV-2 Rapid Antibody Test demonstrates excellent clinical performance without cross-reactivity to common cold samples and res...

    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.

  2. Version published to 10.1016/j.ijid.2020.11.164
  3. Version published to 10.1101/2020.09.01.20180687v2 on medRxiv
  4. Version published to 10.1101/2020.09.01.20180687v1 on medRxiv