β_(2)-微球蛋白测定试剂盒性能测评  

A Performance Evaluation of β_(2)-Microglobulin Assay Kits

作　　者：杨忠 李达 彭絮 孙莉 李胜民 YANG Zhong;LI Da;PENG Xu;SUN Li;LI Shengmin(Beijing Institute of Medical Device Testing,Beijing 101111,China;NMPA Key Laboratory for Quality Evaluation of In Vitro Diagnostics,Beijing 101111,China;Beijing Key Laboratory of Medical Device Testing and Safety Evaluation,Beijing 101111,China)

机构地区：[1]北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心),北京101111 [2]国家药品监督管理局体外诊断试剂质量评价重点实验室,北京101111 [3]北京市医疗器械质量安全评价重点实验室,北京101111

出　　处：《标记免疫分析与临床》2023年第3期512-516,共5页Labeled Immunoassays and Clinical Medicine

基　　金：国家重点研发计划(编号:2020YFC2004501)。

摘　　要：目的对10个不同厂家的β_(2)-微球蛋白测定试剂盒(胶乳增强免疫比浊法)进行性能测试和比对,评价试剂盒性能的差异和产生的原因,供制造商和使用单位参考。方法对试剂盒的空白限、准确度、重复性、互换性、系统间比例差异和系统差异、系统结果的一致性进行测评,采用Medcalc20和Excel 2010软件进行数据分析。结果有3个试剂盒的空白限大于线性下限;重复性均符合要求;用国际标准物质ERM-DA470k验证准确度相对偏差,多数达不到试剂盒相关行业标准规定的要求;浓度较高的质控品互换性不好;系统间检测结果一致性中等程度以上的超过95%,51%的系统组合间存在系统偏差,84%的系统组合间存在的比例差异。结论试剂盒与仪器组成检测系统后的重复性良好,但部分试剂盒线性区间设置不合理;10个试剂盒的系统间一致性程度很高,但多数试剂盒的系统间存在比例差异或系统偏差。Objective To conduct the performance tests and comparison for theβ_(2)-Microglobulin assay kits(Latex enhanced immunoturbidimetry)from 10 different manufacturers,so as to evaluate the performance differences and reasons which can be referred by manufacturers and end-user.Methods The blank limit,accuracy,repeatability,interchangeability,ratio difference between systems,system differences,and consistency of system results of the assay kits were evaluated.The software of Medcalc20 and Excel 2010 were used for the data analysis.Results The blank limit of 3 assay kits was greater than the lower linear limit.Precision for all assay kits met the requirement.The relative deviation of accuracy was verified by international reference material ERM-DA470K which most assay kits could not meet the requirement of the relevant industry standard.The commutability of the high concentration of the quality controls was not satisfactory.The consistency of the test results between the systems was more than 95%above the moderate degree or above.51%of system combinations had systematic deviations.84%of system combinations had proportional differences.Conclusion The precision of the system which combined by the test kit and analyzer is well.However,the setting of linearity interval for some assay kits is not reasonable.The results of the 10 systems evaluated are highly consistent,while there are also systematic deviations or proportional differences among most of the systems.

关 键 词：Β2-微球蛋白 试剂盒 胶乳增强免疫比浊 性能测评 

分 类 号：R392-33[医药卫生—免疫学]