Evaluating an app-guided self-test for influenza: lessons learned for improving the feasibility of study designs to evaluate self-tests for respiratory viruses.
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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DOI：
10.1186/s12879-021-06314-1
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发表时间：
2021-06-29
影响因子：
3.7
通讯作者：
Seattle Flu Study investigators
中科院分区：
文献类型：
--
作者：
Zigman Suchsland ML;Rahmatullah I;Lutz B;Lyon V;Huang S;Kline E;Graham C;Cooper S;Su P;Smedinghoff S;Chu HY;Sewalk K;Brownstein JS;Thompson MJ;Seattle Flu Study investigators
季节性流感导致显著的发病率和死亡率。快速自我检测可以改善社区环境中获得流感检测的机会。我们的目的是评估移动的应用程序引导的流感快速自检对成人流感样疾病（ILI）的诊断准确性，并确定对流感和其他呼吸道病毒的家庭检测进行准确性研究的最佳方法。这项横断面研究招募了在线自我报告ILI的成年人。参与者下载了一个移动的应用程序，该应用程序引导他们通过两个低鼻拭子自我样本。参与者使用侧流试验检测索引拭子。将检测准确度结果与在研究实验室中使用分子测定法检测甲型/B流感病毒的参考拭子进行比较。分析包括739名参与者，80%为25-64岁，79%为女性，73%为白色。基于实验室参考检测，流感阳性率为5.9%。在开始测试的人中，92%的人报告了自我测试结果。与实验室参考标准相比，参与者对测试结果解释的灵敏度和特异性分别为14%（95%CI 5-28%）和90%（95%CI 87-92%）。一个移动的应用程序促进了研究程序，以确定基于家庭的流感检测的准确性，但是，检测灵敏度较低。招募临床环境外的自我报告ILI症状的个人可能会降低流感的发病率和/或减轻疾病的严重程度。需要通过入选标准和快速运输检测或预先定位检测在症状发作的48小时内早期识别研究受试者，以便在病毒载量较高时在病程早期进行自我检测。在线版本包含补充材料，可通过10.1186/s12879-021-06314-1获得。
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. 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. 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. 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. The online version contains supplementary material available at 10.1186/s12879-021-06314-1.
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作者：
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