|
KMID : 1100820150050020069
|
|
Laboratory Medicine Online
2015 Volume.5 No. 2 p.69 ~ p.76
|
|
|
Performance Evaluation of BAROZEN H, a Networking Blood Glucose Monitoring System for Medical Institutions
|
|
Lee Jun-Hyung
Cha Young-Joo
|
|
|
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
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|