Real-time optical analysis of a colorimetric LAMP assay for SARS-CoV-2 in saliva with a handheld instrument improves accuracy compared with endpoint assessment

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Abstract

No abstract available

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  1. SciScore for 10.1101/2021.01.13.21249412: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    RandomizationThe 20 samples (10 negative and 10 positive) were randomized and blinded and processed through the entire standardized assay procedure.
    BlindingThe 20 samples (10 negative and 10 positive) were randomized and blinded and processed through the entire standardized assay procedure.
    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:
    These limitations have hindered effort to scale the use of this testing platform to meet the exponential expansion in testing demand. Antibody-based detection platforms are emerging as an alternative to RT-PCR based assays to meet the rising demand for rapid, point-of-care testing. While antibody-based detection methods can be adapted for at-home, point-of-care detection, or mobile testing, this methodology is inherently less sensitive than nucleic acid amplification-based assays. Isothermal nucleic acid amplification merges the mobility of antibody-based assays with the high sensitivity of RT-PCR as an efficient platform to expand COVID-19 testing. In this study, we have built upon the colorimetric endpoint readout of LAMP-based testing and have provided proof-of-design for a mobile platform that utilizes isothermal nucleic acid amplification in conjunction with direct detection of SARS-Cov-2 from saliva. We have paired SARS-CoV-2 detection during isothermal nucleic acid amplification with a mobile, handheld device that detects colorimetric changes during isothermal amplification similar to that of a microplate reader used in previous studies.12 This method is capable of detecting purified (synthetic) SARS- CoV-2 RNA template within an order of magnitude of single particle detection (5.25 genomes/reaction) therefore comparable to the theoretical maximum sensitivity of other RT- PCR-based approaches as well as other LAMP-based SARS-CoV-2 detection designs. COLOR initially rec...

    Results from TrialIdentifier: No clinical trial numbers were referenced.


    Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).


    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

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