Evaluation of the Self-Testing Blood Glucose Monitoring System GlucoDr.S According to ISO 15197:2013 Guidelines.
- Author:
Namhee KIM
1
;
Bo Gyung KIM
;
Sun Hee JUN
;
Kyunghoon LEE
;
Tae Jung OH
;
Sung Hee CHOI
;
Soo LIM
;
Sang Hoon SONG
;
Woon Heung SONG
;
Junghan SONG
;
Hak Chul JANG
Author Information
- Publication Type:Original Article
- Keywords: POCT; GlucoDr.S; Blood Glucose Monitoring System; ISO15197:2013
- MeSH: Biological Science Disciplines; Blood Glucose*; Consensus; Glucose; Hematocrit; Humans; Xylose
- From:Laboratory Medicine Online 2018;8(3):77-86
- CountryRepublic of Korea
- Language:Korean
- Abstract: 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 (<100 mg/dL) and 3.4–3.7% (≥100 mg/dL), respectively, and 3.7 mg/dL (<100 mg/dL) and 2.1–2.6% (≥100 mg/dL), respectively. Each coefficient of determination (R2) for linearity of the 3 reagent lots was >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 <100 mg/dL and ≥100 mg/dL, >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.
