IGI-LuNER: single-well multiplexed RT-qPCR test for SARS-CoV-2

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Abstract

Commonly used RT-qPCR-based SARS-CoV-2 diagnostics require 2-3 separate reactions or rely on detection of a single viral target, adding time and cost or risk of false-negative results. Currently, no test combines detection of widely used SARS-CoV-2 E- and N-gene targets and a sample control in a single, multiplexed reaction. We developed the IGI-LuNER RT-qPCR assay using the Lu na Probe Universal One-Step RT-qPCR master mix with publicly available primers and probes to detect SARS-CoV-2 N gene, E gene, and human RNase P ( NER ). This combined, cost-effective test can be performed in 384-well plates with detection sensitivity suitable for clinical reporting, and will aid in future sample pooling efforts, thus improving throughput of SARS-CoV-2 detection.

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  1. SciScore for 10.1101/2020.12.10.20247338: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: We confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Experimental Models: Cell Lines
    SentencesResources
    Limit of Detection: Heat-inactivated virus was generated in the BSL3 laboratory at the University of California, Berkeley. Briefly, SARS-CoV-2 was cultured in Vero E6 cells and titers were determined using cytopathic effect (CPE) assays.
    Vero E6
    suggested: RRID:CVCL_XD71)
    Software and Algorithms
    SentencesResources
    Ct values were exported into Excel version 16.42 (Microsoft Office, Redmond WA) and plotted with Prism 8.4.3 (Graphpad, San Diego, CA) as the average value ± standard deviation.
    Excel
    suggested: None
    Prism
    suggested: (PRISM, RRID:SCR_005375)
    Ct values were exported into Excel version 16.42 (Microsoft Office, Redmond WA) and plotted with Prism 8.4.3 (Graphpad, San Diego, CA) as the average value ± standard deviation. Reproducibility: Eight clinically reported negative samples (OP/mid-turbinate swabs in 4mL of 1x RNA/DNA shield) were pooled to generate a negative sample matrix for spike-in experiments.
    Graphpad
    suggested: (GraphPad, RRID:SCR_000306)
    Clinical Concordance: 91 OP/mid-turbinate samples with clinically reported results (61 positive, 30 negative), based on original RNA extraction with the MagMax Viral/Pathogen Nucleic Acid Isolation Kit and the TaqPath RT-PCR COVID-19 kit (ThermoFisher), were arrayed from the original tubes (containing residual volume of approximately 3.5mL of 1x DNA/RNA shield) into a 96-well deep-well plate on the Microlab STARlet.
    ThermoFisher
    suggested: (ThermoFisher; SL 8; Centrifuge, RRID:SCR_020809)

    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.