Salivary SARS-CoV-2 antigen rapid detection: A prospective cohort study

  1. Daniela Basso
  2. Ada Aita
  3. Andrea Padoan
  4. Chiara Cosma
  5. Filippo Navaglia
  6. Stefania Moz
  7. Nicole Contran
  8. Carlo-Federico Zambon
  9. Anna Maria Cattelan
  10. Mario Plebani

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Abstract

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  1. Version published to 10.1016/j.cca.2021.02.014
  2. ScreenIT

    SciScore for 10.1101/2020.12.24.20248825: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: After obtaining giving fully informed consent in writing (Local Ethic Committee Nr. 27444), patients were asked to collect a morning saliva sample (Salivette device, SARSTEDT AG & Co, Nümbrecht, Germany).
    IRB: After obtaining giving fully informed consent in writing (Local Ethic Committee Nr. 27444), patients were asked to collect a morning saliva sample (Salivette device, SARSTEDT AG & Co, Nümbrecht, Germany).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variableOne hundred thirty-eight (52 females, 86 males, mean age±SD: 56±17 years) were COVID-19 inpatients, and 96 (47 females, 49 males, mean age±SD: 42±15 years) were outpatients screened for suspected SARS-CoV-2 (i.e. contact with a SARS-CoV-2 positive subject or with typical symptoms).

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    For molecular testing, saliva and swab samples were mixed (2:1, v:v) with Nuclisens® easyMAG® Extraction buffer 1 immediately before extraction of RNA using an automated platform
    Nuclisens®
    suggested: None
    Statistical analysis of data: The statistical analysis of data was made with Stata software ver. 13.1 (Lakeway drive, TX, US).
    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:
    SARS-CoV-2 antigen determination in NPS by point-of-care immunochromatographic assays or by chemiluminescent assays developed with laboratory instrumentation has been proposed in order to overcome these limitations, and to facilitate large scale analyses (22). This approach allows a reduction in the analytical time but does not obviate the need to perform NPS by trained personnel within dedicated medical cabinets. This bottle-neck could be overcome by using self-collected saliva. To identify the best possible strategy for detecting the infection by antigenic rapid testing, in this second wave pandemic we studied two series of subjects representing real world scenarios: inpatients with COVID-19 disease and outpatients screened for SARS-CoV-2 due to a history of positive contact or suspect clinical signs. NPS and saliva, simultaneously collected from all patients enrolled in the study, were used as matrices for antigen detection employing immunochromatographic assays and rapid CLEIA, and for viral sequences identification by rRT-PCR. As expected, the prevalence of positive rRT-PCR findings in NPS was lower among outpatients (3%) than inpatients (61%); in this latter group, it progressively declined in parallel with duration of symptoms, as the viral load, assessed by the Ct value, declined. Based on this observation, our patients’ series was subdivided according to the duration of symptoms before enrollment: less than one week, one to two weeks, and more than two weeks. The mol...

    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 10.1101/2020.12.24.20248825v1 on medRxiv