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Validation of 12-lead Smartphone-based spandan ultra 12L electrocardiogram durations and amplitudes analysis as compared to the standard 12-lead electrocardiogram

Year: 2026

Type: article

Abstract: Background . Electrocardiography (ECG) is a valuable tool for diagnosing cardiac disorders, with a 12-lead ECG being the gold standard. However, the traditional 12-lead ECG machine is hospital-based, which restricts access. The Smartphone-based 12-Lead ECG (Spandan Ultra 12L ECG) is a portable, simultaneous 12-lead ECG device designed for real-time cardiac monitoring. This study compares its accuracy with a Standard 12-lead ECG system (Philips PageWriter ECG). Objective . To evaluate the accuracy and reliability of the Smartphone-based 12-Lead ECG device in measuring ECG interval, amplitude, and duration measurements as compared to the Standard 12-lead ECG. Methods . A prospective, single-blinded, cross-sectional study was conducted in a hospital ECG room in Dehradun, India. 405 participants aged ≥ 20 years in ECG recordings using the both the ECG machine. After applying the exclusion criteria, 75 participants were excluded, and 330 participants’ ECG recordings were analyzed. Statistical analyses included paired t-tests to compare significant differences, Pearson correlation coefficients (PCC) to assess linear association, and Bland-Altman (BA) analysis to evaluate the agreement between the two devices. Results . Twelve-lead Standard (n = 330) and Smartphone-based 12-Lead (n = 330) ECG waveforms from 330 participants (mean age 52.14 years); 169 (51.21%) males were analyzed. No statistically significant differences were found between both the ECGs for all measured parameters, with p-values ranging from 0.090 for P-wave duration to 0.965 for Q-wave amplitude. PCC showed high linear correlation between the both the ECGs across ECG intervals (0.818–0.938), amplitudes (>0.92), and durations (0.700–0.944). BA analysis confirmed minimal bias, with limits of agreement (LOA) within clinically acceptable ranges. Conclusion . The Smartphone-based 12-Lead ECG device showed high accuracy and reliability in the evaluation of ECG parameters, as compared to the Standard 12-lead ECG system. Its portability, smartphone compatibility, and ease of use make it a promising diagnostic tool for regular clinical applications and timely ECG assessment.

Source: Biomedical Physics & Engineering Express

DOI: 10.1088/2057-1976/ae596f