Abstract: Background Early detection of atrial fibrillation is important for timely initiation of anticoagulation. Handheld single-lead electrocardiogram devices are recommended for atrial fibrillation screening, but limited evidence is available for its use in Chinese population. Objective To investigate the diagnostic performance of a hand-held single-lead ECG device(MyDiagnostick) in atrial fibrillation screening and its potential in the opportunistic screening of atrial fibrillation in community. Methods Diagnostic performance of the MyDiagnostick was examined among 296 hospitalized patients with atrial fibrillation, using 12-lead electrocardiograms as the gold standard. Sensitivity, specificity, and kappa value was calculated. A single-time point opportunistic screening for atrial fibrillation was conducted using the MyDiagnostick in 1 577 community dwellings. Detection rate of atrial fibrillation was calculated. Results The sensitivity and specificity of the MyDiagnostick for diagnosing atrial fibrillation were 0.945 and 0.947, respectively. The Kappa value was of 0.892. Among 1 577 community dwellings, 60 cases of atrial fibrillation were detected (3.80%), among which 33 cases were new-onset atrial fibrillation (2.13%). Male gender (OR=2.553, 95%CI=1.504 -4.333) and a history of stroke/transient ischemic attack/thrombosis (OR=2.840，95%CI=1.330-6.064) were risk factors for atrial fibrillation in the community population. Conclusion The handheld single-lead electrocardiogram device of MyDiagnostick has a high accuracy in atrial fibrillation diagnosis and shows the potential to be used in atrial fibrillation screening in community.

Key words: Atrial fibrillation, Hand-held single-lead ECG device, Community, Screening

摘要： 背景 心房颤动（以下简称房颤）的早期发现与管理非常重要，手持式单导联心电设备被推荐用于房颤筛查，但其在中国人群中的准确性和应用证据缺乏。目的 分析手持式单导联心电设备（MyDiagnostick房颤检测棒）的房颤检测效能，探索该设备应用于社区人群机会性房颤筛查的效果。方法 本研究的研究对象包括两部分。第一部分为准确性检验样本：纳入2022年2月—2023年8月就诊于广东省人民医院心血管内科的房颤患者296例。第二部分为社区筛查样本：2023年10月—2024年6月在广州市三所社区卫生中心就诊的居民1577名。在房颤患者中，以12导联心电图为“金标准”，测量MyDiagnostick房颤检测棒对房颤诊断的灵敏度、特异度和Kappa值；在社区人群中使用MyDiagnostick手持式单导联心电设备进行单次机会性房颤筛查，分析其房颤检出率。结果 MyDiagnostick 房颤检测棒用于房颤检测的灵敏度和特异度分别为0.945 和0.947；其与 12 导联心电图对房颤的诊断具有强一致性（Kappa系数=0 .892）。在 1 577 名社区居民中检出房颤60 例（房颤检出率3 .80%），其中新发房颤33 例（新发房颤检出率2 .13%）。男性（OR=2.553，95%CI=1 .504~4 .333）和卒中 / 短暂脑缺血发作 / 血栓史（OR=2.840，95%CI=1 .330~6 .064，P<0.05）是社区人群发生房颤的危险因素。结论 MyDiagnostick 手持式单导联心电设备有较高的房颤检测准确性，应用于社区人群机会性房颤筛查中具有较好的筛查效果。

关键词: 心房颤动, 手持式单导联心电设备, 社区, 筛查