Diagnostic Accuracy of an App-Guided, Self-Administered Test for Influenza among Individuals presenting to General Practice with Influenza-Like Illness: Study Protocol

Victoria Lyon, Monica Zigman Suchsland, Monique Chilver, Nigel Stocks, Barry Lutz, Philip Su, Shawna Cooper, Chunjong Park, Libby Lavitt, Alex Mariakakis, Shwetak Patel, Chelsey Graham, Mark Rieder, Cynthia LeRouge, Matthew Thompson
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RDTScan helps community health workers capture high-quality images of malaria rapid diagnostic tests (RDTs) collected in real-world environments without the need of extra hardware.

Abstract

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.