Lab Med Online.  2015 Apr;5(2):69-76. 10.3343/lmo.2015.5.2.69.

Performance Evaluation of BAROZEN H, a Networking Blood Glucose Monitoring System for Medical Institutions

Affiliations
  • 1Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea. chayoung@cau.ac.kr

Abstract

BACKGROUND
We evaluated the analytical performance of Barozen H (i-SENS Inc., Korea), a new glucometer equipped with networking function for medical institutions, according to the ISO 15197:2003 and ISO/DIS 15197:2011 guidelines.
METHODS
We measured the precision of 10 Barozen H glucometers, in terms of repeatability and intermediate precision, and determined their accuracy relative to that of automatic chemistry analyzer AU5421 (Beckman Coulter, USA). Three other glucometers-Precision PCx (Abbott, USA), Glucocard Sigma (Arkray, Japan), and SureStep Flexx (Johnson & Johnson, USA) were also evaluated, and their accuracies and hematocrit interferences were compared.
RESULTS
The standard deviation and coefficient of variation of Barozen H for repeatability and intermediate precision were 0.11-0.15 mmol/L and 2.3-3.6%, respectively. With respect to accuracy, in accordance with ISO 15197:2003 criteria, Barozen H yielded 98.0% of results within +/-0.83 mmol/L or +/-20%. Further, per the ISO/DIS 15197:2011 criteria, 95.2% of results were within +/-0.83 mmol/L or +/-15%; Barozen H was the only glucometer satisfying the more stringent ISO/DIS 15197:2011 criteria. Error grid analysis showed that all results from Barozen H were in zone A, indicating its excellent clinical accuracy. Hematocrit, ranging from 20% to 60% did not cause any significant interference.
CONCLUSIONS
Barozen H showed excellent analytical performance, and it was the most clinically accurate glucometer tested. It can be expected to provide reliable results satisfying ISO/DIS 15197:2011 as well as ISO 15197:2003 criteria.

Keyword

Blood glucose; Blood glucose self-monitoring; Diabetes mellitus; Glucose oxidase; Hematocrit; Point-of-care systems
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