Handheld 6-Lead Validated for QT Monitoring

JAMAnetwork.com

In this diagnostic study, a standard 12-lead ECG measurement was compared to KardiaMobile 6L in a tuberculosis trial. Performed in South Africa, the study assessed 191 participants. Triplicate reference standard 12-lead ECG results were human calibrated with readers blinded to 6-lead ECG results.

At a QTc interval threshold of 500 milliseconds, the KardiaMobile 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 standard 12-lead ECG monitoring in resource-constrained settings.

Key Takeaways:

• At a diagnostic cut point of 500 milliseconds, 98.8% of clinic visits (483 of 489) were correctly classified by the handheld 6-lead device:
• 482 as true negatives (ie, QTc interval <500 milliseconds measured by both devices)
• 1 as true positive (ie, QTc interval of ≥500 milliseconds measured by both devices)
• In resource-limited settings where QT screening is needed, the KardiaMobile 6L can be a cost-effective (20-50 times less costly than the conventional ECG), efficient, and reliable triage tool, resulting in more patient-centered care
• There is proven diagnostic accuracy, repeatability, and feasibility with KardiaMobile 6L

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