Diagnostic Accuracy of a Smartphone-based 12-lead ECG for Detection of Common Bradycardias, Tachycardias, and Ectopic Arrhythmias

Background and Aim: Electrocardiography (ECG) remains the cornerstone for diagnosing cardiac arrhythmias.The purpose of this study was to assess the diagnostic performance of a smartphone-based ECG device (Spandan Ultra 12-lead) compared with a standard 12-lead ECG device for detecting common cardiac arrhythmias (bradycardias, tachycardias, and ectopic arrhythmias), with a cardiologist as the reference standard. Materials and Methods:The study was a prospective, cross-sectional, single-blind, observational, comparative diagnostic accuracy study conducted in 321 patients aged ≥20 years who exhibited signs of arrhythmias.For analysis of diagnostic performance, sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), accuracy, F-score, positive and negative likelihood ratios [(positive likelihood ratio (PLR) and negative likelihood ratio (NLR)], Matthews correlation coefficient (MCC), and the Farrington-Manning score were used to provide a comprehensive evaluation.Results: The mean age was 51.95±14.51years; 50.47% were male.The smartphone-based ECG demonstrated higher sensitivity (86.54% vs. 77.80%),specificity (93.68% vs. 91.38%),PPV (72.58% vs. 64.61%),NPV (97.29% vs. 95.31%),accuracy (92.52% vs. 89.09%),F1 score (0.79 vs. 0.70), PLR (13.7 vs. 9.05), MCC (0.75 vs. 0.64), area under the curve (0.851 vs. 0.846), and lower NLR (0.14 vs. 0.24) compared with the standard 12-lead ECG.The Farrington-Manning non-inferiority test demonstrates that the smartphone-based ECG was non-inferior to the standard 12-lead ECG on all validation parameters. Conclusion:The Spandan Ultra 12-lead smartphone-based ECG is a reliable diagnostic tool for detecting common bradycardias, tachycardias, and ectopic arrhythmias.Its simultaneous multichannel recording enables rapid and accurate rhythm assessment, demonstrating comparable diagnostic performance to that of the standard 12-lead ECG and serving as a complementary diagnostic tool for detecting common arrhythmias.