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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.
Figures and Tables
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.
Table 1
Precision of Barozen H
Table 2
System accuracy according to ISO 15197:2003
Table 3
System accuracy according to ISO/DIS 15197:2011
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