ASIA unversity:Item 310904400/4436
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    题名: Clinical evaluation of the eBsensor hand-held blood glucose monitoring system.
    作者: Chen CC;Tai DY;Ho P;Lai YK;Lin JJ;Mao SJT;Lin CC;Hsieh YC;Chiang HC;Dai KS.
    贡献者: Department of Biotechnology
    日期: 2007-02
    上传时间: 2009-11-26 01:43:08 (UTC+0)
    出版者: Asia University
    摘要: BACKGROUND: Home glucose monitoring system is increasingly recognized as an important tool for glycemic control. We evaluated the clinical performance of the eBsensor glucose monitoring system. METHODS: Fingertip capillary blood glucose concentrations from 282 subjects were measured using eBsensor glucose monitoring system and compared against predicate devices and the Yellow Springs Instruments (YSI) 2300 blood glucose analyzer. Accuracy and precision of the eBsensor glucose monitoring system were assessed using several methods. The comparative study between the eBsensor and 2 currently marketed monitoring systems was performed. RESULTS: The 282 eBsensor readings covered a wide range from 2.6 to 24.4 mmol/l. Deming regression and Pearson correlation analyses showed a linear relationship between the eBsensor readings and the YSI reference method (eBsensor=0.9496 YSI+0.4127 mmol/l; r=0.98). Error Grid analysis demonstrated that 100% of the eBsensor readings in clinically acceptable zones A and B. The CVs for the 6 lots of strips were within the satisfactory interval (<6%). The comparative study showed that the eBsensor readings correlated well with the OneTouch Ultra values (r=0.97) and the Glucocard II values (r=0.97). CONCLUSIONS: eBsensor is a reliable glucose monitoring system which provides high accurate and precise glucose readings over a wide range of glucose concentrations.
    關聯: Clinica Chimica Acta 377(1-2):170-3
    显示于类别:[生物科技學系] 期刊論文

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