Lab Med Online.  2015 Jan;5(1):6-14. 10.3343/lmo.2015.5.1.6.

Performance Evaluation of Glucometer Barozen H Based on ISO 15197 Standards

Affiliations
  • 1Department of Laboratory Medicine and Genetics, Sungkyunkwan University School of Medicine, Seoul, Korea. nayadoo@hanmail.net
  • 2Department of Laboratory Medicine and Genetics, Samsung Medical Center, Seoul, Korea.

Abstract

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.

Keyword

Barozen H; Glucometer; ISO 15197:2011; Performance evaluation
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