Performance evaluation of blood glucose monitoring devices.
Performance evaluation of blood glucose monitoring devices.
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DOI：
10.1089/152091503322526969
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发表时间：
2003-01-01
影响因子：
5.4
通讯作者：
Hortin, Glen
中科院分区：
文献类型：
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作者：
Chen, Ellen T;Nichols, James H;Hortin, Glen
许多新技术被应用于测量血糖浓度，但缺乏评估这些设备性能的标准化方法。我们试图确定评估血糖测量设备性能的关键要素。我们在一项针对糖尿病患者常用的四个品牌的血糖仪的多中心研究中检查了这些要素。我们用四个品牌的血糖仪分别测试了对照材料、加标全血样本和 461 个肝素化全血样本，一式三份，并通过己糖激酶 (HK) 方法（结合了美国国家标准与技术研究所开发的参考材料）分析了这些样本的血浆葡萄糖浓度。血糖仪测试在三个地点进行，有多个操作员、仪表和代表性批次的试剂。我们评估了血糖仪的系统偏差、随机误差和临床意义。仪表非常精确，变异系数为 0.98，估计标准误差为 S(y/x)
Many new technologies are being applied to measure blood glucose concentrations, but there is a lack of a standardized approach to evaluate performance of these devices. We sought to identify the key elements in evaluating the performance of devices for measuring blood glucose. We examined these elements in a multicenter study of four brands of glucose meters that are commonly used by diabetic patients. We tested control materials, spiked whole blood specimens, and 461 heparinized whole blood specimens in triplicate by each of the four brand glucose meters, and analyzed the plasma glucose concentrations of these specimens by a hexokinase (HK) method that incorporated reference materials developed by National Institute of Standards and Technology. Testing with glucose meters was performed at three sites, with multiple operators, meters, and representative lots of reagents. We evaluated the systematic bias, random error, and clinical significance of glucose meters. Meters were precise with a coefficient of variation of 0.98 and standard error of estimation S(y/x)