血清葡萄糖氧化酶法自主研发生化诊断试剂的临床研究  

Clinical research of serum glucose of glucose oxidase method biochemistry diagnosis reagent of independent research and development

作　　者：李雪梅[1] 王惠萱[1] 唐建国 贾雄飞[1] 王珂[1] 朱光旭[1] 陈忠明[1] 

机构地区：[1]中国人民解放军昆明总医院检验科,昆明650032 [2]中生北控生物技术有限公司,北京102200

出　　处：《国际检验医学杂志》2011年第3期297-298,共2页International Journal of Laboratory Medicine

基　　金：国家高技术研究发展计划(863计划)重点课题(2006AA020901)

摘　　要：目的进行自主研发的中生北控生物科技公司(中生)血清葡萄糖(Glu)生化诊断试剂的临床研究。方法自主研发血清Glu生化诊断试剂自身性能评价包括空白吸光度、重复性和线性检测。并以进口德国Roche诊断试剂为对照试剂(X),中生诊断试剂为受试试剂(Y),分别测定血清Glu含量。结果受试试剂(Y)空白吸光度、重复性和线性检测均符合要求,且与对照试剂(X)的检测性能具有良好的相关性。结论受试试剂(Y)自身性能良好,安全性和有效性符合临床应用要求。Objective To evaluate the performance of independent research and development serum glucose（Glu） biochemistry diagnosis reagent. Methods Evaluate the performance of independent research and development serum Glu biochemistry diagnosis reagent：measures blank absorbance, repeatability and linearity. To evaluate contrast and bias of two reagents in accordance with EPg-A2,science designs to experiment a project, take imports the biochemistry diagnosis reagent of German Roche as the control group（X）, the biochemistry diagnosis reagent of domestic Biosino as the experimental group（Y）. Measure the serum Glu content in Japanese Olympus AU5421 automatic biochemistry analyzer. Results absorbance, repeatability and linearity of independent research and development serum Glu the biochemistry diagnosis reagent are up to the mustard. Conclusion The independent research and development Glu biochemistry diagnosis reagent is security,effective and meets the clinical practice requirement.

关 键 词：血清 葡萄糖 氧化还原酶类 方法 指示剂和试剂 生物医学研究 

分 类 号：R446.1[医药卫生—诊断学]