In this diagnostic study, a 12-lead (12L) ECG measurement was compared to KardiaMobile 6L in a tuberculosis trial. Performed in South Africa, the study assessed 191 participants. Triplicate reference standard 12L ECG results were human calibrated with readers blinded to 6L ECG results.
The handheld 6L device had a high negative predictive value of 99.8%.
This study suggests that simplified, handheld 6-lead ECG devices are effective triage tests that could reduce the need to perform 12L ECG monitoring in resource-constrained settings.
Key Takeaways:
- KardiaMobile 6L is 99.8% accurate
- The device could reduce the need to perform 12L ECG monitoring in resource-limited settings
- There is proven diagnostic accuracy, repeatability, and feasibility with the 6L ECG device