Clinical sensitivity and interpretation of PCR and serological COVID‐19 diagnostics for patients presenting to the hospital

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Abstract

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  1. SciScore for 10.1101/2020.06.19.20135723: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study was conducted with approval from the local Institutional Review Board.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Serology: An in-house enzyme-linked immunosorbent assay was used to measure IgG, IgA, and IgM antibodies that target the SARS-CoV-2 receptor binding domain (RBD) within the spike protein.
    IgM
    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: We detected the following sentences addressing limitations in the study:
    Using available published data (3-7, 12, 14) and data presented here from our hospital, we offer the following five diagnostic principles for consideration: Limitations in our study include relatively small numbers, a retrospective design, and selection bias due to the specific setting and testing practice. We evaluated symptomatic, mostly hospitalized patients and we cannot derive recommendations for asymptomatic or mildly symptomatic patients from our data. Due to limited availability of tests and time constraints during an ongoing pandemic, we do not have daily samples. Date of symptom onset is not consistently available, subjective, and affected by recall biases – yet, it represents a useful anchor point for disease time course in symptomatic patients. Notably, the eclipse period ranges from 2-14 days (18-21) and some patients already mounted a serologic response at the time of presentation, which can be taken as an argument for the early y-axis deviation from zero in the serology curve and a confirmation of date of symptom onset as an imperfect marker. We caution that the presented serology data are specific to our ELISA, and we cannot extrapolate to anti- SARS-CoV-2 antibody responses in general. Nonetheless, other publications indicate that the time courses are comparable (14, 17, 22). Our serological studies measured antibodies to the RBD of SARS-CoV-2. We chose this viral antigen because of its specificity to SARS-CoV-2, and because anti-RBD antibodies are typically ...

    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.