血清尿酸自主研发生化诊断试剂的临床研究  

Clinical research of serum uric acid biochemistry diagnosis reagent of independent research and development

作　　者：王惠萱[1] 贾雄飞[1] 唐建国 滕毅[1] 佘文婕[1] 朱光旭[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290-292,共3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血清尿酸(UA)生化诊断试剂的临床研究。方法对自主研发的血清UA生化诊断试剂进行性能评价,并与进口优质UA生化诊断试剂进行对比和偏倚评估。结果自主研发血清UA生化诊断试剂空白吸光度、重复性和线性检测符合要求;与公认的优质进口UA生化诊断试剂具有良好的相关性,系统误差符合国际标准要求。结论自主研发UA生化诊断试剂自身性能良好,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 uric acid（UA） biochemistry diagnosis reagent. Methods Evaluate the performance of independent research and development serum UA biochemistry diagnosis reagent：measure blank absorbance, repeatability and linearity. Design to experiment a project, take imports the biochemistry diagnosis reagent of German Olympus as the control group, the biochemistry diagnosis reagent of domestic Biosino as the experimental group. Results Blank absorbance, repeatability and linearity of independent research and development serum UA biochemistry diag nosis regent are up to the mustard. Conclusion The independent research and development UA biochemistry diagnosis reagent is security, effective and meets the clinical practice requirement.

关 键 词：尿酸 指示剂和试剂 生物医学研究 

分 类 号：R446.1[医药卫生—诊断学]