CONTOUR®血糖监测系统的准确性。
Accuracy of the CONTOUR® blood glucose monitoring system.
作者信息
Harrison Bern, Leazenby Cheryl, Halldorsdottir Solveig
机构信息
Bayer HealthCare LLC, Diabetes Care, Tarrytown, New York 10591, USA.
出版信息
J Diabetes Sci Technol. 2011 Jul 1;5(4):1009-13. doi: 10.1177/193229681100500425.
OBJECTIVE
The aim of the study was to assess the accuracy of the CONTOUR® blood glucose monitoring system (BGMS) according to the International Organization for Standardization's International Standard 15197 (ISO 15197:2003) guidelines and to more stringent criteria.
METHOD
Finger stick blood samples from 105 subjects with diabetes (25 with type 1, 77 with type 2, and 3 with type unknown) were tested using the CONTOUR BGMS and YSI glucose analyzer.
RESULTS
99.3% of results were within ISO 15197:2003 criteria (±15 mg/dl of YSI results at glucose concentrations <75 mg/dl and ±20% at glucose concentrations ≥75 mg/dl). Additionally, 96.7% of results were accurate according to more stringent criteria (±15 mg/dl of YSI results for glucose concentrations <100 mg/dl and ±15% for glucose concentrations ≥100 mg/dl). Error grid analysis showed that 99.3% and 0.7% of results were within zones A and B, respectively.
CONCLUSION
The CONTOUR BGMS exceeded both the minimum acceptable accuracy based on ISO 15197:2003 and the more stringent accuracy criteria.
目的
本研究旨在根据国际标准化组织的国际标准15197（ISO 15197:2003）指南以及更严格的标准，评估CONTOUR®血糖监测系统（BGMS）的准确性。
方法
使用CONTOUR BGMS和YSI葡萄糖分析仪对105名糖尿病患者（25名1型糖尿病患者、77名2型糖尿病患者和3名糖尿病类型不明患者）的指尖血样本进行检测。
结果
99.3%的结果符合ISO 15197:2003标准（葡萄糖浓度<75 mg/dl时YSI结果±15 mg/dl，葡萄糖浓度≥75 mg/dl时±20%）。此外，根据更严格的标准（葡萄糖浓度<100 mg/dl时YSI结果±15 mg/dl，葡萄糖浓度≥100 mg/dl时±15%），96.7%的结果是准确的。误差网格分析显示，分别有99.3%和0.7%的结果在A区和B区。
结论
CONTOUR BGMS超出了基于ISO 15197:2003的最低可接受准确性以及更严格的准确性标准。
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