Saliva as a testing sample for SARS-CoV-2 detection by RT-PCR in low prevalence community settings

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Abstract

Objectives

The number of COVID-19 cases is increasing globally and there is an urgency for a simple non-invasive method for the detection of SARS-CoV-2. Our study aimed to demonstrate that saliva can be used as a specimen for SARS-CoV-2 detection notably for the screening of extensive population groups via pooling.

Methods

To demonstrate that saliva is an appropriate specimen for SARS-CoV-2 detection a field study including 3,660 participants was performed between September 29 and October 1, 2020. We collected paired nasopharyngeal/oropharyngeal swabs (NPS) and saliva specimens and processed them within 24 hours of collection. We performed 36 serial measurements of 8 SARS-CoV-2 positive saliva samples to confirm the stability of the specimen and completed 37 pools of saliva samples by adding one positive specimen per pool.

Results

Saliva specimens were stable for testing for up to 24 hours. Overall, 44 salival samples (1.2%) tested positive for SARS-CoV-2 during the field study. The results of saliva samples were consistent with those obtained from NPS from the same patient with 90% sensitivity (95% CI 68.3%-98.7%) and 100% specificity during the first two weeks after the onset of symptoms. Using pooling strategy 796 RT-PCR tests were performed. All pools showed 100% positivity in different pooling proportions.

Conclusions

Our findings demonstrate that saliva is an appropriate specimen for pooling and SARS-CoV-2 screening with accurate diagnostic performance. Patient-performed simple specimen collection allows testing an extensive number of people rapidly, obtaining results of the spread of SARS-CoV-2 and allowing authorities to take timely measures.

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  1. SciScore for 10.1101/2020.10.20.20216127: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.


    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:
    There were some limitations in our study: the size of the cohort of participants was limited, the selected laboratory-developed RT-PCR method for evaluation was used, also a lack of multicenter observation. Future studies extending the cohort are needed to confirm current findings and provide the implications in clinical practice.

    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.