Point‐of‐Care Platform for Rapid Multiplexed Detection of SARS‐CoV‐2 Variants and Respiratory Pathogens

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Abstract

The rise of highly transmissible SARS‐CoV‐2 variants brings new challenges and concerns with vaccine efficacy, diagnostic sensitivity, and public health responses to end the pandemic. Widespread detection of variants is critical to inform policy decisions to mitigate further spread, and postpandemic multiplexed screening of respiratory viruses will be necessary to properly manage patients presenting with similar respiratory symptoms. In this work, a portable, magnetofluidic cartridge platform for automated polymerase chain reaction testing in <30 min is developed. Cartridges are designed for multiplexed detection of SARS‐CoV‐2 with either identification of variant mutations or screening for Influenza A and B. Moreover, the platform can perform identification of B.1.1.7 and B.1.351 variants and the multiplexed SARS‐CoV‐2/Influenza assay using archived clinical nasopharyngeal swab eluates and saliva samples. This work illustrates a path toward affordable and immediate testing with potential to aid surveillance of viral variants and inform patient treatment.

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  1. SciScore for 10.1101/2021.05.10.21256995: (What is this?)

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

    Table 1: Rigor

    EthicsField Sample Permit: Clinical sample testing: Clinical swab and saliva specimens were previously collected under Johns Hopkins IRB #00246027.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    BlindingSpecimens were de-identified and blinded before testing.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The sample well heat block was custom machined out of 6061 aluminum and mounted onto a power resistor (Riedon PF1262-5RF1) with a steel M3 screw, while the PCR heat block was machined from 145 copper and mounted onto a thermoelectric element (Peltier Mini Module, Custom Thermoelectric) and heatsink using thermally conductive epoxy (Arctic Alumina Thermal Adhesive, Arctic Silver).
    Arctic
    suggested: (ARCTIC, RRID:SCR_005989)

    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:
    For realistic deployment, there are a few limitations to the current platform that must be addressed. In particular, the current cartridges are not shelf-stable for prolonged storage at room-temperature and are refrigerated or frozen prior to use. We are currently investigating techniques for built-in storage of dry reagents to allow stability at ambient conditions. To include testing for additional variants or respiratory pathogens, the cartridge would need to be expanded from the current 2-well design with additional PCR wells for higher multiplexing. Given the limited clinical sample volume available in this study, the assay design used a maximum 50 µL input per sample, though further improvement to sensitivity to prevent false-negatives may be achieved by adapting the cartridge and binding buffer to be compatible with larger volumes of sample.

    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.
    • Thank you for including a protocol registration statement.

    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.