10/10 Accuracy Analysis of a Self-Monitoring Blood GlucoseSystem

摘要

The OneTouch Verio Reflect (LifeScan Global Corp., Malvern, PA) blood glucose (BG) meter iscleared for self-monitoring of blood glucose in the E.U., United States, and other regionsworldwide. In the E.U., ISO15197:2015 accuracy criteria requires at least 95% of values to bewithin ±15 mg/dL or ±15% of a reference comparator at <100 mg/dL and ≥100 mg/dL,respectively, across the claimed system operating range.1 U.S. clearance requires at least 95% of all results to be within ±15% of comparator and99% of all results to be within 20% of the comparator method.2