Korean J Health Promot.  2016 Dec;16(4):223-230. 10.15384/kjhp.2016.16.4.223.

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

Affiliations
  • 1Department of Family Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Korea. dryoo@schmc.ac.kr

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

Keyword

ISO 15197:2013; Blood glucose self-monitoring; Diabetes mellitus; G400

MeSH Terms

Blood Glucose
Blood Glucose Self-Monitoring
Diabetes Mellitus
Hematocrit
Blood Glucose

Figure

  • Figure 1. Accuracy of G400. (A) Consensus Error grids of each lots. (B) Accuracy plot of each lots.

  • Figure 2. Interference of hematocrit. The two bold lines represent the acceptance criteria: ±10 mg/dL of the results at glucose concentrations <100 mg/dL, ±10% of the results at glucose concentrations ≥100 mg/dL. Interval 1 is 30–50 mg/dL, interval 2 is 96–144 mg/dL, interval 3 is 280–420 mg/dL.

  • Figure 3. Dose-response evaluation.

  • Figure 4. User performance. (A) Consensus error grid. (B) Accuracy plot.


Reference

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