Analytic Performance Evaluation of Blood Monitoring System G400 according to ISO 15197:2013.
10.15384/kjhp.2016.16.4.223
- Author:
Doheun CHUNG
1
;
Byungkeun CHOI
;
Byungwook YOO
;
Chooyon CHO
;
Sungho HONG
;
Jungeun OH
;
Yongjin CHO
Author Information
1. Department of Family Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea. dryoo@schmc.ac.kr
- Publication Type:Original Article
- Keywords:
ISO 15197:2013;
Blood glucose self-monitoring;
Diabetes mellitus;
G400
- MeSH:
Blood Glucose;
Blood Glucose Self-Monitoring;
Diabetes Mellitus;
Hematocrit
- From:Korean Journal of Health Promotion
2016;16(4):223-230
- CountryRepublic of Korea
- Language:Korean
-
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 15197:2013. METHODS: We evaluated the G400 according to the ISO 15197:2013 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 15197:2013 criteria
