Evaluation of the Self-Testing Blood Glucose Monitoring System GlucoDr.S According to ISO 15197:2013 Guidelines

BACKGROUND: The performance of the self-monitoring of blood glucose in patients with diabetes should be properly evaluated to ensure strict glycemic control. This study evaluated the self-testing Blood Glucose Monitoring System GlucoDr.S™ (All Medicus Co., Ltd., Korea). METHODS: This study recruited 120 patients. Use of the glucometer was evaluated according to ISO 15197:2013 guidelines. The YSI 2300 STAT PLUS Glucose Analyzer (YSI Life Sciences, USA) was used as the reference device. RESULTS: The standard deviation and coefficients of variation ranges for measurement repeatability and intermediate measurement precision conducted with 10 meters and 3 reagent lots on the same day were 2.7–3.2 mg/dL (0.99. The influence effect of hematocrit and the 24 interference agents was not significant, except for xylose. A system accuracy test was conducted with 100 subjects taking duplicate measurements from each of the 3 reagent lots. When glucose levels were 95% of the samples were within ±15 mg/dL and within ±15% of the average measured values of the reference measurement, respectively. In Consensus Error grid analysis, all results were distributed in zone A and B. The results of the user performance evaluation using 115 lay persons were also included in the acceptance range. CONCLUSION: The GlucoDr.S™ showed acceptable performance according to the ISO 15197:2013 guidelines and could be a clinically useful self-testing glucometer.

Performance Evaluation of B. Braun Omnitest 5 Blood Glucose Monitoring System for Self-Monitoring of Blood Glucose

BACKGROUND: We evaluated the accuracy of the B. Braun Omnitest 5 blood glucose monitoring system (BGMS; Infopia Co. Ltd., Korea), which was recently developed for self-monitoring of blood glucose. METHODS: Precision was assessed according to Clinical and Laboratory Standards Institute guideline EP5-A3 with control materials containing low, normal, and high levels of glucose. Linearity was evaluated over the range of 52.5–548.0 mg/dL prepared from patient samples. For system accuracy, 100 capillary blood samples measured by the B. Braun Omnitest 5 BGMS were compared to plasma-equivalent blood glucose values of the fingertip blood samples measured by the YSI 2300 STAT PLUS glucose analyser (YSI Life Sciences, USA). Accuracy was evaluated according to the International Organization for Standardization (ISO) 15197: 2013 criteria. RESULTS: The range for the total coefficient of variation (%) was 1.5%–4.9% for three lots of strips. Both within-run precision and within-laboratory precision fulfilled the manufacturer's claim. ISO 15197: 2013 states that more than 95% of blood glucose measurement values must be within ±15 mg/dL for ranges below 100 mg/dL and ±15% for ranges above 100 mg/dL. Each of B. Braun Omnitest 5 lots satisfied ISO 15197: 2013, as 98.5% (197/200), 97.0% (194/200), and 99.5% (199/200) of values were within range. In consensus error grid analysis, respectively, 99.5%, 99.0%, and 100.0% of measurement values of each lot were within zone A, indicating that an average of over 99.0% of values were within zone A. CONCLUSIONS: B. Braun Omnitest 5 provided reliable results and satisfied the ISO 15197: 2013 accuracy criteria. This test is an appropriate BGMS for the self-monitoring of blood glucose.