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采用安培生物传感器技术的血糖仪的技术与临床评估

Technical and clinical evaluation of a glucose meter employing amperometric biosensor technology.

作者信息

Demir Suleyman, Yilmazturk Gamze Can, Aslan Diler

机构信息

Pamukkale University, School of Medicine, Department of Biochemistry, Denizli, Turkey.

出版信息

Diabetes Res Clin Pract. 2008 Mar;79(3):400-4. doi: 10.1016/j.diabres.2007.10.006. Epub 2007 Nov 19.

DOI:10.1016/j.diabres.2007.10.006
PMID:18023908
Abstract

The objective of this study was to assess accuracy and precision of the Optimum H System for measuring glucose in fresh venous whole blood samples. Ninety-one whole blood specimens were analyzed duplicate on two optimum blood glucose meter and compared to YSI reference analyser and Beckman LX20 laboratory analyser. The study demonstrated that the Optimum H System gives clinically accurate, plasma equivalent glucose results for venous samples, compared to the YSI1.12 reference method. All results were within the clinically acceptable A and B zones of the Parkes error grid, with 98.6% falling within zone A. The mean bias of the Optimum H System versus the YSI1.12 reference was +5.39%, which is consistent with the strip claim that slightly higher results may be observed when using venous samples. The Optimum H System results showed good precision, with an overall mean CV of 3.0%. Plasma results from the Beckman laboratory analyser correlated well with the YSI*1.12 whole blood reference with a slightly higher mean bias of +3.92%. The study demonstrated the Optimum H System to give clinically accurate and precise results for glucose in fresh venous whole blood samples.

摘要

本研究的目的是评估Optimum H系统在新鲜静脉全血样本中测量葡萄糖的准确性和精密度。对91份全血标本在两台Optimum血糖仪上进行重复分析,并与YSI参考分析仪和贝克曼LX20实验室分析仪进行比较。研究表明,与YSI1.12参考方法相比,Optimum H系统可为静脉样本提供临床准确的、等同于血浆的葡萄糖结果。所有结果均在Parkes误差网格的临床可接受A区和B区内,98.6%落在A区。Optimum H系统相对于YSI1.12参考的平均偏差为+5.39%,这与试纸条声称使用静脉样本时可能观察到略高的结果一致。Optimum H系统的结果显示出良好的精密度,总体平均变异系数为3.0%。贝克曼实验室分析仪的血浆结果与YSI*1.12全血参考结果相关性良好,平均偏差略高,为+3.92%。该研究表明,Optimum H系统可为新鲜静脉全血样本中的葡萄糖提供临床准确和精确的结果。

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