Würstle Silvia, Erber Johanna, Hanselmann Michael, Hoffmann Dieter, Werfel Stanislas, Hering Svenja, Weidlich Simon, Schneider Jochen, Franke Ralf, Maier Michael, Henkel Andreas G, Schmid Roland M, Protzer Ulrike, Laxy Michael, Spinner Christoph D
Department of Internal Medicine II, School of Medicine, University Hospital rechts der Isar, Technical University of Munich, Munich, Germany.
Department for Sport and Health Sciences, Professorship of Public Health and Prevention, Technical University of Munich, Munich, Germany.
JMIR Form Res. 2022 Jan 4;6(1):e32564. doi: 10.2196/32564.
Large-scale, polymerase chain reaction (PCR)-based SARS-CoV-2 testing is expensive, resource intensive, and time consuming. A self-collection approach is a probable alternative; however, its feasibility, cost, and ability to prevent infections need to be evaluated.
This study aims to compare an innovative self-collection approach with a regular SARS-CoV-2 testing strategy in a large European industrial manufacturing site.
The feasibility of a telemedicine-guided PCR-based self-collection approach was assessed for 150 employees (intervention group) and compared with a regular SARS-CoV-2 testing approach used for 143 employees (control group). Acceptance, ergonomics, and efficacy were evaluated using a software application. A simulation model was implemented to evaluate the effectiveness. An interactive R shiny app was created to enable customized simulations.
The test results were successfully communicated to and interpreted without uncertainty by 76% (114/150) and 76.9% (110/143) of the participants in the intervention and control groups, respectively (P=.96). The ratings for acceptability, ergonomics, and efficacy among intervention group participants were noninferior when compared to those among control group participants (acceptability: 71.6% vs 37.6%; ergonomics: 88.1% vs 74.5%; efficacy: 86.4% vs 77.5%). The self-collection approach was found to be less time consuming (23 min vs 38 min; P<.001). The simulation model indicated that both testing approaches reduce the risk of infection, and the self-collection approach tends to be slightly less effective owing to its lower sensitivity.
The self-collection approach for SARS-CoV-2 diagnosis was found to be technically feasible and well rated in terms of acceptance, ergonomics, and efficacy. The simulation model facilitates the evaluation of test effectiveness; nonetheless, considering context specificity, appropriate adaptation by companies is required.
基于聚合酶链反应（PCR）的大规模新冠病毒检测成本高昂、资源密集且耗时。自我采样方法可能是一种替代方案；然而，其可行性、成本以及预防感染的能力需要评估。
本研究旨在比较一种创新的自我采样方法与欧洲一家大型工业制造企业中常规的新冠病毒检测策略。
对150名员工（干预组）评估了基于远程医疗指导的PCR自我采样方法的可行性，并与用于143名员工的常规新冠病毒检测方法（对照组）进行比较。使用软件应用程序评估接受度、人体工程学和有效性。实施了一个模拟模型来评估有效性。创建了一个交互式R闪亮应用程序以实现定制模拟。
干预组和对照组分别有76%（114/150）和76.9%（110/143）的参与者成功接收并毫无疑问地理解了检测结果（P = 0.96）。干预组参与者在可接受性、人体工程学和有效性方面的评分与对照组参与者相比并不逊色（可接受性：71.6%对37.6%；人体工程学：88.1%对74.5%；有效性：86.4%对77.5%）。发现自我采样方法耗时更少（23分钟对38分钟；P < 0.001）。模拟模型表明，两种检测方法都能降低感染风险，且自我采样方法由于敏感性较低，其有效性往往略低。
发现用于新冠病毒诊断的自我采样方法在技术上可行，在接受度、人体工程学和有效性方面评分良好。模拟模型有助于评估检测有效性；尽管如此，考虑到具体情况，公司需要进行适当调整。
