自制胱抑素C免疫诊断试剂的性能评价（基础医学范文）.docVIP

自制胱抑素C免疫诊断试剂的性能评价（基础医学范文） 文档信息 属性： F-00NLWH，doc格式，正文6195字。质优实惠，欢迎下载！ 适用： 作为文章写作的参考文献，解决如何写好实用应用文、正确编写文案格式、内容摘取等相关工作。 作者： 佚名 目录 TOC \o 1-9 \h \z \u 目录 1 正文 1 搞要 1 关键字：胱抑素C 胶乳增强免疫比浊法 诊断试剂 性能评价 2 2 结果 5 3 讨论 7 参考文献 7 论文原创声明（模板） 9 论文致谢（模板） 10 正文 自制胱抑素C免疫诊断试剂的性能评价（基础医学范文） 搞要 摘要：摘要目的：评价自主研发的胱抑素（Cyc）C免疫诊断试剂（终点法）在自动化检测血清中CycC浓度的性能。方法：采用奥林巴斯AU680全自动生化分析仪，经重复性、线性试验后，测定血清中CycC浓度，进行方法学评价及与美国DiazymeCycC试剂（终点法）比较。结果：试剂在两个水平质控下测定的变异系数（CV）分别为%和%，在0～8mg/L浓度范围内，线性良好。两种试剂测定血清CycC浓度的相关系数较好，相关系数r=。结论：自主研发的CycC试剂盒操作简便、快速、准确、稳定，安全性及有效性符合临床应用要求，可以满足大批量临床样本的常规和自动化分析，是一种值得推广的诊断试剂 关键字：胱抑素C 胶乳增强免疫比浊法 诊断试剂 性能评价 中图分类号：； 文献标识码：B 文章编号：1006-1533（2015）21-0077-03 Evaluation of the performance of an independently developed Cys C immune diagnosis reagent ZHANG Yujing* （Shanghai Fosun Long March Medical Science Co. Ltd.， Shanghai 200444， China） ABSTRACT Objective： To evaluate the performance of an independently developed immune diagnosis reagent in the conventional and automatic determination of Cys C concentration in the clinical serum. Methods： The concentrations of Cys C were determined with Olympus AU680 automatic biochemical analyzer after testing the blank absorbance， repeatability and linearity. The evaluation of the reagent was carried out and the determination results were compared with those of the control reagent （Diazyme）. Results： The coefficients of variation （CV） of Cys C concentrations at two levels of quality control were % and %. The results of determination showed a good linearity over the range of ～ mg/L. There was a good correlation between two reagents （r=）. Conclusion： The Cys C reagent made by our company can provide a simple， quick， accurate and stable method for the determination of Cys C concentrations in the clinical serum and meet the requirement of the conventional and automated analysis of mass clinical samples. This method may be worthy of promotion. KEY WORDS Cys C； latex-enhanced immunoturbidimetry； diagnosis reagent； performance evaluation