Multicenter validation study of an easily applicable cybernetic prototype device that assesses electrocardiographic abnormalities

A newly developed digital prototype electrocardiographic device (CardioScan/sup TM/) for assessment of electrocardiographic abnormalities was validated in a multicenter study. Recordings from the test device and digital 12 channel electrocardiograms (ECG) were performed at rest for 289 in- and outpatients at three study centers. Sensitivity and specificity of the test device for the correct detection of abnormal ECG were calculated by comparing the results to expert findings from 12 channel ECG. The device correctly assessed 63% of all abnormal ECG with a specificity of 86%. Because of its sufficient sensitivity and its high specificity and its simple and rapid application, this device may be useful for automatic screening tests for electrocardiographic abnormalities, which should be presented to a physician for further evaluation.