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KMID : 1100820150050010006
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Laboratory Medicine Online
2015 Volume.5 No. 1 p.6 ~ p.14
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Performance Evaluation of Glucometer Barozen H Based on ISO 15197 Standards
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Kim Yeong-Bin
Seo Ji-Young
Lee Soo-Youn
Park Hyung-Doo
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Abstract
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Background: We have evaluated the analytical performance of Barozen H (i-SENS Inc. Seoul, Korea), which was developed for glucose testing and can be connected to hospital information network systems.
Methods: We evaluated the precision of ten glucometers based on repeatability and intermediate precision according to the guidelines of the International Standardization Organization (ISO) 15197:2011. The linearity of patient samples was in the range of 30.7-551.2 mg/dL. The accuracy of the results of Barozen H and the correlation of these results and those of the two other glucometers in comparisons with the Modular D reference device (Roche Diagnostics Ltd., Switzerland) were evaluated using 150 capillary blood and venous whole blood samples.
Results: The ranges for the repeatability and intermediate precision of ten Barozen H glucometers were 1.58-4.61% and 2.85-5.48%, respectively. The linearity was expressed by y=0.9681x+2.0791, and the coefficient of determination (R2) was 0.9996. When venous whole blood samples were used, the correlation coefficient (r) was 0.9914. When glucose levels were under 100 mg/dL, 95.2% of Barozen H results were within ±15 mg/dL, and when glucose levels were 100 mg/dL or higher, 97.2% were within ±15%. When capillary blood samples were used, 41.4% (under 100 mg/dL) and 55.4% (100 mg/dL or higher) of Barozen H results were within ±15 mg/dL and ±15%, respectively.
Conclusions: Barozen H provided reliable results and satisfied the ISO15197:2011 criteria when venous whole blood samples were used. It is thought to be clinically useful as a hospital point-of-care glucometer.
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KEYWORD
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Barozen H, Glucometer, ISO 15197:2011, Performance evaluation
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