Chen Chien-Chih, Tai Der-Yan, Ho Ping, Lai Yiu-Kay, Lin Jui-Jane, Mao Simon J T, Lin Chia-Chi, Hsieh Yu-Chen, Chiang Hsiang-Cheng, Dai Ken-Shwo
Wei-Gong Memorial Hospital, Miaoli, and The Institude of Biotechnology, College of Life Science, National Tsing Hua University, Hsinchu, Taiwan.
Clin Chim Acta. 2007 Feb;377(1-2):170-3. doi: 10.1016/j.cca.2006.09.023. Epub 2006 Oct 3.
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.
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.
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).
eBsensor is a reliable glucose monitoring system which provides high accurate and precise glucose readings over a wide range of glucose concentrations.
家用血糖监测系统日益被视为血糖控制的重要工具。我们评估了eBsensor血糖监测系统的临床性能。
使用eBsensor血糖监测系统测量了282名受试者的指尖毛细血管血糖浓度，并与对照设备和黄泉仪器（YSI）2300血糖分析仪进行比较。采用多种方法评估了eBsensor血糖监测系统的准确性和精密度。进行了eBsensor与2种目前市场上销售的监测系统之间的对比研究。
282次eBsensor读数范围广泛，从2.6至24.4 mmol/l。Deming回归和Pearson相关分析显示eBsensor读数与YSI参考方法之间呈线性关系（eBsensor = 0.9496 YSI + 0.4127 mmol/l；r = 0.98）。误差网格分析表明，100%的eBsensor读数处于临床可接受的A区和B区。6批试纸条的变异系数在满意区间内（<6%）。对比研究表明，eBsensor读数与OneTouch Ultra值（r = 0.97）和Glucocard II值（r = 0.97）相关性良好。
eBsensor是一种可靠的血糖监测系统，在广泛的血糖浓度范围内能提供高度准确和精确的血糖读数。
