摘要
目的：验证由豪迈胱抑素c检测试剂盒和贝克曼库尔特UniCelDxC800全自动生化分析仪组成的检测系统的性能特征。方法：对该检测系统的精密度、正确度、可报告范围和参考区问进行验证。结果：2个不同浓度水平样本的批内、批间变异系数均小于2％，均小于厂家声明；对厂家的定值参考物质进行检测，低浓度参考物质的绝对偏差为0．03～0．06mg／L，高浓度参考物质的回收率为94％~102％。使用厂家的定值物质进行回收试验，回收率为104．5％～108．4％。绝对偏差和回收率均与厂家声明一致；验证的分析测量范围为0．10～8．0mg／L，临床可报告范围为0．10～16．0mg／L；验证的参考区间与厂家声明的（0．57～1．01mg／L）一致。结论：由豪迈胱抑素C检测试剂盒和贝克曼库尔特UniCelDxC800全自动生化分析仪组成的检测系统的性能特征与豪迈公司声明一致，本研究所用性能验证的方案和方法简便、可行。
Objective： To verify the main performance characteristics of the detection system composed of HOMA cystatin C assay kit and Beckman-Coulter UniCel DxC800 Synchron Clinical System. Methods The precision, trueness, reportable range and reference interval of the quantitative detection system were analyzed according to the guidelines of CLSI. Results： For the two different levels samples, the coefficients of variation of intra-assay and inter-assay were less than 2%, less than manufacturers statement. The absolute deviations of the low concentration reference materials were 0.03-0.06mg/L, the recoveries of the high concentration reference materials were 94%-102%. The recovery tests were applied by using HOMA reference materials.The recoveries were 104.5%-108.4%. The absolute deviations and the recoveries were consistent with manufacturers statement. The verified measurement range was 0.10-8.0mg/L, the clinical reportable range was 0. 10-16.0mg/L. The verified reference intervals were 0.57-1.01mg/L, and consistent with with manufacturers statement. Conclusion： The main performance characteristics of the quantitative detection system in the detection of cystatin C were consistent with manufacturers statement.The performance verification procedures and methods were simple and practicable.
出处
《中国医疗器械信息》
2013年第5期13-16,37,共5页
China Medical Device Information
关键词
胱抑素C
性能验证
定量测定
cystatin C, performance verification, quantitative detection system
