Article Text

Protocol
Diagnostic accuracy of an app-guided, self-administered test for influenza among individuals presenting to general practice with influenza-like illness: study protocol
  1. Victoria Lyon1,
  2. Monica Zigman Suchsland1,
  3. Monique Chilver2,
  4. Nigel Stocks2,
  5. Barry Lutz3,
  6. Philip Su4,
  7. Shawna Cooper4,
  8. Chunjong Park5,
  9. Libby Rose Lavitt5,
  10. Alex Mariakakis5,
  11. Shwetak Patel5,
  12. Chelsey Graham6,
  13. Mark Rieder6,
  14. Cynthia LeRouge7,
  15. Matthew Thompson1
  1. 1Family Medicine, University of Washington, Seattle, Washington, USA
  2. 2Discipline of General Practice, University of Adelaide, Adelaide, South Australia, Australia
  3. 3Bioengineering, University of Washington, Seattle, Washington, USA
  4. 4Audere, Seattle, Washington, USA
  5. 5Computer Science, University of Washington, Seattle, Washington, USA
  6. 6Brotman Bay Institute for Precision Medicine, University of Washington, Seattle, Washington, USA
  7. 7College of Business, Florida International University, Miami, Florida, USA
  1. Correspondence to Victoria Lyon; vlyon{at}uw.edu

Abstract

Introduction Diagnostic tests for influenza in Australia are currently only authorised for use in clinical settings. At-home diagnostic testing for influenza could reduce the need for patient contact with healthcare services, which potentially could contribute to symptomatic improvement and reduced spread of influenza. We aim to determine the accuracy of an app-guided nasal self-swab combined with a lateral flow immunoassay for influenza conducted by individuals with influenza-like illness (ILI).

Methods and analysis Adults (≥18 years) presenting with ILI will be recruited by general practitioners (GP) participating in Australian Sentinel Practices Research Network. Eligible participants will have a nasal swab obtained by their GP for verification of influenza A/B status using reverse transcription polymerase chain reaction (RT-PCR) test at an accredited laboratory. Participants will receive an influenza test kit and will download an app that collects self-reported symptoms and influenza risk factors, then instructs them in obtaining a low-nasal self-swab, running a QuickVue influenza A+B lateral flow immunoassay (Quidel Corporation) and interpreting the results. Participants will also interpret an enhanced image of the test strip in the app. The primary outcome will be the accuracy of participants’ test interpretation compared with the laboratory RT-PCR reference standard. Secondary analyses will include accuracy of the enhanced test strip image, accuracy of an automatic test strip reader algorithm and validation of prediction rules for influenza based on self-reported symptoms. A post-test survey will be used to obtain participant feedback on self-test procedures.

Ethics and dissemination The study was approved by the Human Research and Ethic Committee (HREC) at the University of Adelaide (H-2019-116). Protocol details and any amendments will be reported to https://www.tga.gov.au/. Results will be published in the peer-reviewed literature, and shared with stakeholders in the primary care and diagnostics communities.

Trial registration number Australia New Zealand Clinical Trial Registry (U1111-1237-0688).

  • biotechnology & bioinformatics
  • molecular diagnostics
  • public health
  • Infection control
http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors VL, MZS, MC, NS, BL, SC, CL and MT contributed to the conceptualisation or design of the work. SC and PS were involved in flu@home end-to-end app development and technical support. LRL, CP, AM and SP contributed to image capture and interpretation feature development. MC and NS managed ASPREN network communication and GP recruitment. CG and MR managed logistics of funding, obtaining and shipping test kits. CL and VL contributed to follow-up survey design. VL, MZS, BL, SC and MT were involved in drafting the article. VL, MZS and MT critically revised the article. VL, MZS, MC, NS, BL, PS, SC, CP, LRL, AM, SP, CG, MR, CL and MT were involved in the final approval of the version to be published. BL and MT are guarantors of this work.

  • Funding The Australian Sentinel Practices Research Network is supported by the Australian Government Department of Health (the Department). The opinions expressed in this paper are those of the authors, and do not necessarily represent the views of the Department. The flu@home study is funded by Audere and Gates Ventures through the Brotman Baty Institute at the University of Washington. The funding reference number is UA194099 (in the University of Adelaide database). The study was conducted in association with the University of Adelaide in Australia, and the University of Washington in the USA. QuickVue Influenza A+B test kit supplies were donated by Quidel Corporation. Gates Ventures and Quidel Corporation were not involved in the design of the study, does not have any ownership over the management and conduct of the study, the data or the rights to publish.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.