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.
Biological Science Disciplines ; Blood Glucose* ; Capillaries ; Consensus ; Glucose ; Humans

No abstract available.
Glucose*

Cancer is a disease which has the huge burden in worldwide, and cancer is the number one cause of death in Korea. At this point, the new framework for cancer monitoring index is required for regional cancer monitoring. Especially, cancer survivors are the important target which is rapidly increasing recently, also cancer survivor’s quality of care should be considered in the cancer monitoring index framework. To develop the Multidimensional Cancer Monitoring Index considering cancer survivor’s quality of care, we took into account cancer continuum which including prevention, detection, diagnosis, treatment, survivorship, assessment of quality of care and monitoring cancer patient, and end-of life care for stage. For target, components of health care delivery system such as patient, family, provider, payer, and policy maker are included. Also, Donabedian model which is a framework for examining health services and evaluating quality of health care such as structure, process, and outcome is applied to contents. This new cancer monitoring framework which includes multidimensional components could help to develop regional cancer monitoring index, and to make national cancer management and prevention policy in the future.