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KMID : 1100820180080030077
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Laboratory Medicine Online
2018 Volume.8 No. 3 p.77 ~ p.86
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Evaluation of the Self-Testing Blood Glucose Monitoring System GlucoDr.S According to ISO 15197:2013 Guidelines
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Kim Nam-Hee
Kim Bo-Gyung
Chun Sun-Hee
Lee Kyung-Hoon
Oh Tae-Jung
Song Sang-Hoon
Choi Sung-Hee
Lim Soo
Song Woon-Heung
Song Jung-Han
Jang Hak-Chul
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Abstract
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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.
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KEYWORD
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POCT, GlucoDr.S, Blood Glucose Monitoring System, ISO15197:2013
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