Evaluation of SARS-CoV-2 rapid antigen diagnostic tests for saliva samples

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Abstract

No abstract available

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  1. SciScore for 10.1101/2021.05.14.21257100: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    BlindingSamples were blind passaged two times on Vero E6 cells for 3 days each.
    Power Analysisnot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Experimental Models: Cell Lines
    SentencesResources
    Vero E6 cells were cultured in Dulbecco’s Modified Eagle Medium (DMEM) supplemented with 10% fetal calf serum (FCS) and gentamycin.
    Vero E6
    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:
    This study has other limitations. One major limitation is that no saliva samples were available from onset of symptoms as i) saliva are not routinely used for SARS-CoV-2 diagnostics and ii) patient recruited in the COVID-19 cohort had been ill for several days before seeking hospital care. Samples were taken in a range of 5-30 days, with a median of 10.5 DPS and thus do not reflect the intended purpose of the RADs, i.e., early after onset of symptoms. Moreover, as we had limited amount of saliva for both the two RADs as well as for the RT-qPCR and cell culture, we had to use less saliva for RNA extraction than is recommended by instructions of the QIAGEN viral extraction kit, thus likely lowering the sensitivity of the RT-qPCR and overestimating the Ct-values. Finally, a relatively low amount of saliva samples was analyzed, thus warranting careful interpretation of the results. To conclude, using SARS-CoV-2 NCp protein and titrated live SARS-CoV-2, our results show that the rapid saliva antigen test DIAGNOS had similar limit of detection as Panbio, a widely used RAD developed for nasopharyngeal samples. DIAGNOS further exhibited a 47% sensitivity on RT-qPCR positive saliva from COVID-19 hospitalized patients. Sensitivity was however higher on samples collected early after symptom onset, more in line with the intended use of the RADs, corresponding also to a higher viral load. The Rapid Response test showed a higher limit of detection as well as lower sensitivity of RT-qPCR po...

    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.

    Results from scite Reference Check: We found no unreliable references.


    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.