Analytic Performance Evaluation of Blood Monitoring System G400 according to ISO 15197:2013

ABSTRACT

BACKGROUND: Self-monitoring of blood glucose is an important component of therapy for diabetes mellitus. The aim of this study was to evaluate the analytic performance evaluation of blood monitoring system G400 according to ISO 151972013. METHODS: We evaluated the G400 according to the ISO 151972013 guideline, we measured precision, accuracy, interference of hematocrit and interfering substances, user performance. RESULTS: Repeatability and intermediate precision of G400 showed standard deviation 2.7–3.8 mg/dL, 2.4–3.6 mg/dL and coefficient of variation 1.9-2.9% and 1.7–3.7%, respectively. Accuracy measured 98–98.5%, satisfied acceptable criteria. Error grid analysis showed that all results of this study were in zone A. Hematocrit between 20% to 60% did not cause interference. Three of 24 interfering substances were not acceptable criteria, and dose-response evaluation was needed. CONCLUSIONS: This study showed that G400 was considered reliable results satisfying the ISO 151972013 criteria