Dai Ken-Shwo, Tai Der-Yan, Ho Ping, Chen Chien-Chih, Peng Wen-Chung, Chen Shih-Te, Hsu Chun-Chieh, Liu Yu-Ping, Hsieh Hsiu-Ching, Yang Chin-Chang, Tsai Ming-Chuan, Mao Simon J T
Bioptik Technology Inc., 1F, No. 9 Industry E. Rd. IV, Science-Based Industrial Park Hsinchu, Hsinchu 300, Taiwan.
Clin Chim Acta. 2004 Nov;349(1-2):135-41. doi: 10.1016/j.cccn.2004.06.010.
Self-monitoring blood glucose device is an important tool for diabetes patients to efficiently control their blood glucose concentrations. We evaluated the accuracy of EasyTouch glucose monitoring system.
Capillary blood glucose concentrations measured using EasyTouch and the reference values obtained from Yellow Springs Instruments (YSI) 2300 STAT were performed in the Department of Laboratory Medicine, Wei-Gong Memorial Hospital. Results were evaluated using (1) linear regression analysis, (2) Clarke Error Grid analysis, (3) percentage of readings within a defined range of deviation from the reference value, (4) bias plots, and (5) coefficients of variation (CVs) calculated from 60 measurements in series.
The window of the 516 EasyTouch readings covered a range from 42 to 555 mg/dl. Linear regression analysis yielded a regression slope 0.9972, intercept 1.899 mg/dl, r2 0.9571, and Syx 14.89 mg/dl. A Clarke Error Grid analysis showed 100% of the EasyTouch readings in clinically acceptable zones A and B. Of the EasyTouch readings, 98.3%, 91.9%, 78.3% and 46.9% were found within +/-20%, +/-15%, +/-10%, and +/-5%, respectively, of the reference values. Further analysis showed that the percentage of EasyTouch readings within the defined intervals was similar in three glucose ranges (< or =100, 101-200, and > or =201 mg/dl). The CVs for the four lots of strips (lot 1 to lot 4) ranged from 3.5 to 5.5%, 2.1 to 4.8%, 1.8 to 3.6%, and 3.0 to 5.7%, respectively.
EasyTouch provides high accurate and precise glucose readings over a wide range of glucose concentrations.
自我血糖监测设备是糖尿病患者有效控制血糖浓度的重要工具。我们评估了易触血糖监测系统的准确性。
在卫功纪念医院检验科，使用易触血糖仪测量毛细血管血糖浓度，并获取来自黄春泉仪器公司（YSI）2300 STAT的参考值。使用以下方法评估结果：（1）线性回归分析；（2）克拉克误差网格分析；（3）与参考值偏差在规定范围内的读数百分比；（4）偏差图；（5）根据60次连续测量计算的变异系数（CV）。
516次易触血糖仪读数范围为42至555mg/dl。线性回归分析得出回归斜率为0.9972，截距为1.899mg/dl，r2为0.9571，Syx为14.89mg/dl。克拉克误差网格分析显示，100%的易触血糖仪读数处于临床可接受的A区和B区。在易触血糖仪读数中，分别有98.3%、91.9%、78.3%和46.9%在参考值的±20%、±15%、±10%和±5%范围内。进一步分析表明，在三个血糖范围（≤100、101 - 200和≥201mg/dl）内，易触血糖仪读数在规定区间内的百分比相似。四批试纸条（批号1至批号4）的变异系数分别为3.5%至5.5%、2.1%至4.8%、1.8%至3.6%和3.0%至5.7%。
易触血糖仪在广泛的血糖浓度范围内提供高度准确和精确的血糖读数。
