摘要
以二茂铁为电子媒介体,研究制作了一次性干法酶电极的便携式血糖仪。血糖检测只需1．5μl的血液标本,并在20s 就能得出检测结果,检测的范围为50-500mg/dl,精度为±1 mg/dl。血糖仪体积为94．3mm×49．2mm×17．8 mm,操作简单, 便于携带。其性能与通过美国FDA认证的YSI 2300 Stat Plus葡萄糖分析仪进行比较研究。结果表明,检测结果的变异系数为3．0%-7．8％,具有线性关系(y=1．006x-1．37,r=0．990,n=118)和很好的可比性,误差图格分析显示所有的数据都在可接受的A、B区。引入二茂铁后,血糖仪的灵敏度显著提高,是一个有效的用于血糖分析的体外诊断仪器。
A portable glucometer is developed with ferrocene as an electron mediator, which is characterized by being easy to operate and portable with the small size of 94.3mm×49.2mm×17.8mm. With this meter, the detection result can be available in no more than 20 seconds with about 1.51μl of blood drawn. The meter has a measurement range from 50mg/dl to 500mg/dl and a precision of lmg/dl. The measurements are compared with the ones from USI 2300 Stat Plus approved by FDA. The coefficient of variation is from 3.0% to 7.8%, and the availability of linear relationship （y=1.006x-1.37, r=0.990, n=1.18） and comparability are demonstrated. Error table analysis proves that ail of measurements are in the acceptable A and B sections. The meter is a validated diagnostic system for in vitro blood glocuse.
出处
《医疗卫生装备》
CAS
2006年第2期9-10,共2页
Chinese Medical Equipment Journal
