Evaluation of SARS-CoV-2 IgG antibody response in PCR positive patients: Comparison of nine tests in relation to clinical data

  1. Paul Naaber
  2. Kaidi Hunt
  3. Jaana Pesukova
  4. Liis Haljasmägi
  5. Pauliina Rumm
  6. Pärt Peterson
  7. Jelena Hololejenko
  8. Irina Eero
  9. Piia Jõgi
  10. Karolin Toompere
  11. Epp Sepp

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Abstract

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  1. Version published to 10.1371/journal.pone.0237548
  2. ScreenIT

    SciScore for 10.1101/2020.07.15.20149617: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: All patients signed informed consent form and filled questionnaire about clinical data.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Five laboratory tests for IgG (SNIBE, Euroimmun, Abbott, Epitope, DiaSorin), one laboratory total Ab (Roche) test, one rapid IgG test (SD Biosensor) and 2 in-house IgG tests (LIPS N and LIPS S-RDB) were included into comparison.
    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:
    Our study has several limitations. Firstly, although the onset of disease could be dated relatively precisely in symptomatic cases, in asymptomatic cases the disease detection depends on random PCR screening of risk groups. Thus, the first positive SARS-CoV-2 PCR is not equivalent to disease onset and one should be careful drawing conclusions based of TTT in such heterogeneous group of patients that includes symptomatic and asymptomatic patients. Secondly, we only analyzed IgG and total antibody values. The main reasons were the absence of IgM tests from several manufacturers (Abbott, DiaSorin) in the time of testing and questionable reliability of available ones. SNIBE and Epitope IgM tests gave significantly lower positive results than IgG tests and added no additional positive cases (all IgM positive cases were also IgG positive). Euroimmun IgA had high positivity rate (ca 90% in COVID-19 patients) but also high proportion of nonspecific reactions (21% of positive and borderline cases) in pre COVID-19 control group. Thus, until reliable commercial IgM and IgA tests are available, we can’t evaluate the role of these antibodies in infection and applicability of these tests in clinical practice or surveillance studies. In conclusion, our study gave new theoretical insight to COVID-19 diagnostic testing and has practical implications. We confirmed that SARS-CoV-2 antibody response depends on clinical symptoms and time of testing, but we also found that this relation is depende...

    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 10.1101/2020.07.15.20149617v1 on medRxiv