Diagnostic and monitoring utilities of saliva for SARS-CoV-2

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Abstract

Introduction

Nasopharyngeal (NP) swab is an invasive procedure that is difficult to perform in pediatric cases and those with special needs. On the other hand, saliva has been a proposed sample given the ease of collection, comfort and the ability to self-collect. The research project aims to study the presence of SARS-CoV-2 in the saliva of suspected COVID-19 patients in comparison to its presence in NP swabs.

Methodology

A cross-sectional study was conducted in October 2020 in COVID19 clinic in the Bahrain Defense Force Hospital. The study compared the presence of SARS-CoV2 by PCR in saliva samples to nasopharyngeal samples. COVID-19 Clinic tests symptomatic, staff, close contacts and pre-operation patients.

Results

The saliva PCR has shown a sensitivity of 72.9% (95% CI: 58.2% - 84.7%) and a specificity of 98.8% (95% CI: 97.8% - 99.4%). The PPV was 74.5% (95% CI 59.7% to 86.1%) and the NPV was 98.6% (95% CI 97.7% to 99.3%). Kappa coefficient of agreement between saliva and NP was 0.723 (95% CI 0.62 to 0.82, p<0.001). Moreover, when restricting cases to symptomatic only, the sensitivity of saliva increased to 86.7% (95% CI 59.5% to 98.3%) while specificity remained high at 97.2%.

Conclusion

The findings of the study suggest that saliva samples have the potential to be used as a screening tool for SARS-CoV-2, especially in symptomatic individuals. This is especially important when it is difficult to collect NP samples. Saliva samples are however at risk of producing more false negative tests.

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  1. SciScore for 10.1101/2020.12.07.20244681: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Statistical analyses were carried out using STATA 15.1 Ethical Approval: The protocol and manuscript for this study were reviewed and approved by the Research and Research Ethics Committee in the Bahrain Defense Force Hospital (Approval Code: BDF/R&REC/2020-494).
    Consent: Informed consent was waived by the Research and Research Ethics Committee.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analyses were carried out using STATA 15.1 Ethical Approval: The protocol and manuscript for this study were reviewed and approved by the Research and Research Ethics Committee in the Bahrain Defense Force Hospital (Approval Code: BDF/R&REC/2020-494).
    STATA
    suggested: (Stata, RRID:SCR_012763)

    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:
    The limitations of the study included the absence of the clinical details and the low prevalence of the infection within the studied sample. The low number of positive cases limiting the strength of the study in assessing the diagnostic ability of saliva samples. Saliva samples could be best utilized for children; however, our study was performed in adult. Yet, the difference in age group is not expected to have significantly alter the results.

    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.