自制胱抑素C免疫诊断试剂的性能评价

Evaluation of the performance of an independently developed Cys C immune diagnosis reagent

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Cyc C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Cyc C浓度，进行方法学评价及与美国Diazyme Cyc C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2.62%和1.79%，在0～8 mg/L浓度范围内，线性良好。两种试剂测定血清Cyc C浓度的相关系数较好，相关系数r=0.995。结论：自主研发的Cyc C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。

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 coefifcients of variation （CV） of Cys C concentrations at two levels of quality control were 2.62% and 1.79%. The results of determination showed a good linearity over the range of 0.25~8.0 mg/L. There was a good correlation between two reagents （r=0.995）.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.