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

Abstract

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±14.51 years; 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.