Retrospective clinical evaluation of 4 lateral flow assays for the detection of SARS-CoV-2 IgG

  1. Kathrine McAulay
  2. Andrew Bryan
  3. Alexander L. Greninger
  4. Francisca Grill
  5. Douglas Lake
  6. Erin J. Kaleta
  7. Thomas E. Grys

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Abstract

No abstract available

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  1. Version published to 10.1016/j.diagmicrobio.2020.115161
  2. ScreenIT

    SciScore for 10.1101/2020.07.01.20129882: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    BlindingBoth readers were essentially blinded, in that the sample metadata (time to disease onset and Abbott results) were not revealed until reading was complete.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Among these 105 specimens, there were 27 from individuals with a history of seasonal coronavirus infection (as determined by a syndromic respiratory PCR test) within 3 years prior to collection (HKU1, n = 13; NL63, n = 6; OC43, n = 6; 229E, n = 2), and 4 specimens reactive for rheumatoid factor, HIV-1 antibody, HAV total antibody, HBV core total antibody and surface antibody, HCV antibody and/or HSV2 antibody.
    HKU1
    suggested: None
    HIV-1
    suggested: None
    HCV
    suggested: None
    HSV2
    suggested: None
    Software and Algorithms
    SentencesResources
    Both readers were essentially blinded, in that the sample metadata (time to disease onset and Abbott results) were not revealed until reading was complete.
    Abbott
    suggested: (Abbott, RRID:SCR_010477)

    Results from OddPub: Thank you for sharing your data.

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    The primary weaknesses include the positive samples from a primarily hospitalized cohort, the retrospective nature of samples (including freeze/thaw), and the lack of fingerstick blood samples, for which many of these assays are designed. In a pandemic, reliable information is essential to public health responses and individual healthcare decisions. These results suggest that, with further investigation/data/study/evaluation, LFIAs could potentially be used to meet that need, particularly in low-resource settings or those with limited access to health care. Importantly, it must be noted that detection of IgG does not mean that neutralizing antibodies are present. There is not yet sufficient data in the literature to determine whether detection of IgG may (or may not) correlate with immunity or protection of future exposure to SARS-CoV-2.

    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 10.1101/2020.07.01.20129882v1 on medRxiv