Laboratory-Developed Test for SARS-CoV-2 Using Saliva Samples at the University of California, Riverside

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Abstract

Here we describe a relatively quick, simple, economical and accurate laboratory developed test (LDT) for detection of SARS-CoV-2 in heated and diluted saliva samples without RNA extraction. Our protocol is a variation of the University of Illinois Urbana-Champaign SHIELD LDT. Differences include chilling of the samples during dilution and using a reduced volume for the qRT-PCR reactions. The level of detection for our LDT is 3125 copies/ml, which compares favorably with other saliva-based tests. Initial validation studies with a limited number of patient samples have demonstrated excellent agreement between results using our LDT and those obtained from external laboratories. The cost of consumables for our test is under $8 and a throughput of 1000 tests/day can be achieved with 3-4 personnel.

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  1. SciScore for 10.1101/2021.02.21.21251691: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIACUC: Because we are not using the saliva samples for research, and are an extension of the clinical laboratory in Veitch Student Health Services, the UCR Institutional Biosafety Committee in the UCR Office of Research and Economic Development did not require a Biological Use Authorization or Institutional Review Board approval for research with human subjects.
    IRB: Because we are not using the saliva samples for research, and are an extension of the clinical laboratory in Veitch Student Health Services, the UCR Institutional Biosafety Committee in the UCR Office of Research and Economic Development did not require a Biological Use Authorization or Institutional Review Board approval for research with human subjects.
    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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.