Lab Med Online.  2018 Jul;8(3):77-86. 10.3343/lmo.2018.8.3.77.

Evaluation of the Self-Testing Blood Glucose Monitoring System GlucoDr.S According to ISO 15197:2013 Guidelines

• Kim N
• Kim BG
• Jun SH
• Lee K
• Oh TJ
• Choi SH
• Lim S
• Song SH
• Song WH
• Song J
• Jang HC

• KMID: 2414128
• DOI: http://doi.org/10.3343/lmo.2018.8.3.77

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.Sâ„¢ (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.Sâ„¢ showed acceptable performance according to the ISO 15197:2013 guidelines and could be a clinically useful self-testing glucometer.

Keyword

POCT; GlucoDr.S; Blood Glucose Monitoring System; ISO15197:2013

MeSH Terms

Biological Science Disciplines
Blood Glucose*
Consensus
Glucose
Hematocrit
Humans
Xylose
Blood Glucose
Glucose
Xylose

Figure

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  Fig. 1. Linearity results of the three lots of GlucoDr.S™. Linearity test was conducted with 9 m, 3 reagent lots, and 11 sample levels. One tester was performed with each combination of reagent lot and sample within one day. Good linearity was indicated at R2≥0.99.

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  Fig. 2. Packed cell volume test. (A) glucose level: 30–50 mg/dL; (B) 96–144 mg/dL; (C) 280–420 mg/dL.

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  Fig. 3. System accuracy of GlucoDr.S™. (A) Difference-plots of capillary blood samples; (B) Clarke error grid analysis of capillary blood samples; (C) Difference-plots of venous blood samples; (D) Clarke error grid analysis of venous blood samples. A zone: No effect on clinical action, B zone: Little or no effect on clinical outcome.

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  Fig. 4. User performance test. (A) Difference-plots; (B) Clarke error grid analysis. A zone: No effect on clinical action, B zone: Little or no effect on clinical outcome.

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