A comparative study to evaluate the clinical utility and performance of a new hand-held mobile electrocardiogram device

Nagaraj Desai, Sunil Kumar S., Guruprasad B. V., Poornima K. S.


Background: Electrocardiogram (ECG) is a non-invasive test which can provide clue for the presence of cardiac diseases. Simple, handheld devices, sufficiently miniaturized are useful for a widespread use. New devices, however, need to be compared with the standard ones for their performance in the real-world practice. Here in we report clinical utility of a handheld device.

Methods: KardioscreenTM is a mobile and handheld device. It’s been approved for safety and performance standards and it has been certified for ‘Conformite Europeenne’ (CE). Using this device, a comparative blinded study with a conventional and commercially available standard 12 lead ECG machine was done. 604 ECGs recorded from 302 patients with various clinical disorders were coded and analyzed by two blinded observers. A third cardiologist adjudicated the reports. The reports were then correlated for the ECG patterns generated and with the clinical diagnosis. Computer generated measurements of various durations and intervals were also analyzed and compared. Regression analysis was used to compare the values. SPSS 21 software was used to analyze the data.

Results: Kardioscreen device could provide recordings to diagnose including ST elevation (99%), non-ST elevation myocardial infarction (94.1%), chamber-hypertrophy (87%), conduction blocks (99%), and arrhythmias (96.4%), with good correlations with the comparator for pattern recognition. Also, computer generated measurements were significantly correlated with the comparator (R=0.96 for HR, R=0.82 for QRSd, R=0.86 for QT/QTc, R=0.76 for PR).

Conclusions: The Kardioscreen device is a reliable tool for electrocardiographic diagnosis of common clinical cardiac disorders.


Comparison, Electrocardiography, Handheld ECG device

Full Text:



Amsterdam EA, Wenger NK, Brindis RG, Casey DE, Ganiats TG, Holmes DR, et al. 2014 AHA/ACC guideline for the management of patients with non–ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;64(24):e139-228.

Kligfield P, Gettes LS, Bailey JJ, Childers R, Deal BJ, Hancock EW, et al. Recommendations for the standardization and interpretation of the electrocardiogram. J Am Coll Cardiol. 2007;49(10):1109-27.

Clemmensen P, Ripa MS, Schoos M, Terkelsen CJ, Holmvang L. Pre-hospital ECG: benefits and difficulties. Available at: 21421294-Pre-hospital-ecg-benefits-and-difficulties.html. Accessed on 3 June 2019.

Quinn T, Johnsen S, Gale CP, Snooks H, McLean S, Woollard M, et al. Effects of prehospital 12-lead ECG on processes of care and mortality in acute coronary syndrome: a linked cohort study from the Myocardial Ischaemia National Audit Project. Heart. 2014;100:944-50.

Daudelin DH, Sayah AJ, Kwong M, Restuccia MC, Porcaro WA, Ruthazer R, et al. Improving use of prehospital 12-lead ECG for early identification and treatment of acute coronary syndrome and ST-elevation myocardial infarction. Circulation: Cardiovasc Quality Outcomes. 2010;3(3):316-23.

Schulman-Marcus J, Prabhakaran D, Gaziano TA. Pre-hospital ECG for acute coronary syndrome in urban India: a cost-effectiveness analysis. BMC Cardiovasc Disorders. 2010;10(1):13.

Bansal A, Joshi R. Portable out‐of‐hospital electrocardiography: A review of current technologies. J Arrhythmia. 2018;34(2):129-38.

Mehta P, Sudheer KM. Development of a Low-Cost, Portable, 12-Lead ECG machine for health-care centres across rural India. J Med Diagn Meth. 2013;2(120):2.

Gajendra G, Shastri R. KardioScree Testing and Validation document, for clinical accuracy and morphology comparison. document number, KS1612-06-01-1P0. Internal test document from M/S iMedrix Inc. Available at: https://www. Accessed on 3 June 2019.