Harmony COVID-19: A ready-to-use kit, low-cost detector, and smartphone app for point-of-care SARS-CoV-2 RNA detection

  1. Nuttada Panpradist
  2. Enos C. Kline
  3. Robert G. Atkinson
  4. Michael Roller
  5. Qin Wang
  6. Ian T. Hull
  7. Jack H. Kotnik
  8. Amy K. Oreskovic
  9. Crissa Bennett
  10. Daniel Leon
  11. Victoria Lyon
  12. Shane D. Gilligan-Steinberg
  13. Peter D. Han
  14. Paul K. Drain
  15. Lea M. Starita
  16. Matthew J. Thompson
  17. Barry R. Lutz

Reviewed by

Read the full article See related articles

Listed in

Log in to save this article

Abstract

A unique four-plexed RT-LAMP test kit operated by health workers can provide faster, more sensitive results than laboratory tests.

Article activity feed

  1. Version published to 10.1126/sciadv.abj1281
  2. Version published to 10.1101/2021.08.12.21261875v2 on medRxiv
  3. ScreenIT

    SciScore for 10.1101/2021.08.12.21261875: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: Usability study: The Harmony usability study was approved by the Institutional Review Board at the University of Washington (IRB#: STUDY00010884), and informed consent was provided by participants.
    Consent: Usability study: The Harmony usability study was approved by the Institutional Review Board at the University of Washington (IRB#: STUDY00010884), and informed consent was provided by participants.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    BlindingXPRIZE contrived sample panel: The blinded panel was assembled and distributed by HudsonAlpha Discovery (Huntsville, AL) for the COVID-19 XPRIZE competition, and information on the samples was revealed to the authors only after results were submitted to XPRIZE.
    Power Analysisnot detected.

    Table 2: Resources

    Recombinant DNA
    SentencesResources
    Preparation of synthetic RNA standards: MERS and SARS-CoV-1 plasmid standards (10006623 and 10006624, Integrated DNA Technologies, Coralville, IA) were amplified using M13 PCR primers to generate DNA templates tagged with T7 promoter sequences.
    SARS-CoV-1
    suggested: RRID:Addgene_170447)
    This gene was then cloned into the expression vector pET His6 TEV LIC cloning vector (2B-T) (a gift from Scott Gradia, Plasmid # 29666, Addgene, Watertown, MA) by ligation independent cloning (38).
    pET His6
    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:
    However, reported tests often have other limitations that may prevent their use in POC testing (Table 1B). Common limitations include use of frozen reagent stocks that must be thawed and then formulated using laboratory pipettes, manual steps for sample processing that require laboratory skill, or detection steps that rely heavily on user interpretation or analysis by a user’s cell phone. Harmony is a complete sample-to-result system that uses ready-to-use reagents for simple 1-minute setup and a dedicated device that reports results without extra post-amplification steps or reliance on user interpretation. Some RT-LAMP tests use end-point lateral flow strips for detection (Table S1), which adds a user step, but more importantly, should not be done at the POC because it exposes the testing site to amplicons that will give false positive results in subsequent tests. Others use in-tube detection by eye (30) or a cell phone (31) which increases the user burden and could introduce additional sources of error. Real-time detection used in Harmony COVID-19 removes the need for extra detection steps or user interpretation. Real-time detection also allows Harmony to report positive results as soon as the SARS-CoV-2 signal appears rather than waiting for an end-point detection method. High viral load samples could be detected in as little as 20 min, which could enable more timely infection control measures to limit viral spread. Harmony real-time detection allows testing without openin...

    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.

  4. Version published to 10.1101/2021.08.12.21261875v1 on medRxiv