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|a Zigman Suchsland, Monica L.
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|a Rahmatullah, Ivan
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|a Lutz, Barry
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|a Lyon, Victoria
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|a Huang, Shichu
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|a Kline, Enos
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|a Graham, Chelsey
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|a Cooper, Shawna
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|a Su, Philip
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|a Smedinghoff, Sam
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|a Chu, Helen Y.
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|a Sewalk, Kara
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|a Brownstein, John S.
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|a Thompson, Matthew J.
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|a Evaluating an app-guided self-test for influenza: lessons learned for improving the feasibility of study designs to evaluate self-tests for respiratory viruses
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|b BioMed Central,
|c 2021-11-01T14:34:03Z.
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|z Get fulltext
|u https://hdl.handle.net/1721.1/136897
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|a Abstract Background Seasonal influenza leads to significant morbidity and mortality. Rapid self-tests could improve access to influenza testing in community settings. We aimed to evaluate the diagnostic accuracy of a mobile app-guided influenza rapid self-test for adults with influenza like illness (ILI), and identify optimal methods for conducting accuracy studies for home-based assays for influenza and other respiratory viruses. Methods This cross-sectional study recruited adults who self-reported ILI online. Participants downloaded a mobile app, which guided them through two low nasal swab self-samples. Participants tested the index swab using a lateral flow assay. Test accuracy results were compared to the reference swab tested in a research laboratory for influenza A/B using a molecular assay. Results Analysis included 739 participants, 80% were 25-64 years of age, 79% female, and 73% white. Influenza positivity was 5.9% based on the laboratory reference test. Of those who started their test, 92% reported a self-test result. The sensitivity and specificity of participants' interpretation of the test result compared to the laboratory reference standard were 14% (95%CI 5-28%) and 90% (95%CI 87-92%), respectively. Conclusions A mobile app facilitated study procedures to determine the accuracy of a home based test for influenza, however, test sensitivity was low. Recruiting individuals outside clinical settings who self-report ILI symptoms may lead to lower rates of influenza and/or less severe disease. Earlier identification of study subjects within 48 h of symptom onset through inclusion criteria and rapid shipping of tests or pre-positioning tests is needed to allow self-testing earlier in the course of illness, when viral load is higher.
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