Background: To assess the diagnostic accuracy of the Spandan Lead II smartphone-based electrocardiogram (ECG) device regarding cardiac arrhythmia, compared with that of the only lead II ECG strip from the gold-standard ECG machine (BPL ECG machine) and the diagnosis by a cardiologist.

Methods: The study, conducted from August 2, 2022, to June 2, 2023, in the local hospital, included 2799 participants aged 20 years and above. This was a single-blinded, cross-sectional study comparing the Spandan ECG device against the Gold Standard ECG and was diagnosed by a cardiologist. Participants referred for ECG testing by a cardiologist were included, and those with a pacemaker and/or ECG artifacts were excluded. To avoid any bias, the diagnosis was blinded to the cardiologist. Sensitivity, specificity, predictive values, F-score, and Matthew’s correlation coefficient of the Spandan device were the parameters on which accuracy was studied.

Results: Among 2799 participants (843 females, 1,956 males), the Spandan ECG system demonstrated high accuracy compared to the gold standard ECG machine, with sensitivity (95.5%), specificity (96.3%), positive predictive value (93.2%), negative predictive value (97.6%), F-Score (0.94), and a P = .913, for P > .001. It identified all arrhythmias without discrepancies and closely aligned with the gold standard ECG, which had slightly lower performance metrics. The study concluded that the Spandan Lead II ECG system is clinically applicable, especially in resource-limited settings.

Conclusion: The Spandan lead II smartphone-based ECG device offers high accuracy in diagnosing cardiac arrhythmias, comparable to standard ECG machines. Its portability, affordability, and ease of use make it a valuable tool for timely diagnosis in almost all clinical and non-clinical settings.