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

MeSH Terms

Blood Glucose Self-Monitoring
Blood Glucose*
Chemistry
Diabetes Mellitus
Glucose Oxidase
Hematocrit
Point-of-Care Systems
Blood Glucose
Glucose Oxidase

Figure

  • Fig. 1 Difference plots of Barozen H and 3 other glucometers. (A) Barozen H, (B) Precision PCx, (C) Glucocard Sigma, (D) SureStep Flexx. The X-axis represents the mean value of the duplicates from the AU5421 chemistry analyzer. The Y-axis shows the difference between the result of each glucometer and that of AU5421. The dotted lines represent the acceptance criteria of ISO/DIS 15197:2011 (±0.83 mmol/L and ±15%).

  • Fig. 2 Consensus error grids for Barozen H and 3 other glucometers. (A) Barozen H, (B) Precision PCx, (C) Glucocard Sigma, (D) SureStep Flexx. The X-axis represents the mean value of the duplicates from the AU5421 chemistry analyzer. The Y-axis shows the results of each glucometer. The percentage values in the box represent the proportion of results belonging to each zone.

  • Fig. 3 Interference of the hematocrit in 4 glucometers. (A) Barozen H, (B) Precision PCx, (C) Glucocard Sigma, (D) SureStep Flexx. The X-axis shows the hematocrit (%) for each sample. The Y-axis shows the bias between each glucometer and the AU5421 chemistry analyzer as a reference measurement procedure. Each bias was presented in difference (mg/dL) at low glucose concentration (30-50 mg/dL, 1.7-2.8 mmol/L) and %difference (%) at mid (96-144 mg/dL, 5.3-8.0 mmol/L) and high (280-420 mg/dL, 15.5-23.3 mmol/L) glucose concentration.


Cited by  1 articles

Analytic Performance Evaluation of Blood Monitoring System G400 according to ISO 15197:2013
Doheun Chung, Byungkeun Choi, Byungwook Yoo, Chooyon Cho, Sungho Hong, Jungeun Oh, Yongjin Cho
Korean J Health Promot. 2016;16(4):223-230.    doi: 10.15384/kjhp.2016.16.4.223.


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