Performance Evaluation of Glucometer Barozen H Based on ISO 15197 Standards

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) 151972011. 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 ISO151972011 criteria when venous whole blood samples were used. It is thought to be clinically useful as a hospital point-of-care glucometer.