C反应蛋白正确度验证物质的定值及应用  

The value transfer and application for CRP trueness verification materials

作　　者：吴春颖[1] 张顺利[2] 马怀安[3] 刘巍[1] 张瑞[2] 岳育红[2] 梁玉芳[2] 赵婷婷[2] 王清涛[2] Wu Chunying;Zhang Shunli;Ma Huaian;Liu Wei;Zhang Rui;Yue Yuhong;Liang Yufang;Zhao Tingting;Wang Qingta(Department of Clinical Laboratory,Beijing Luhe Hospital Affiliated to Capital Medical University,Beijing 101100,China)

机构地区：[1]首都医科大学附属北京潞河医院检验科,101100 [2]首都医科大学附属北京朝阳医院检验科北京市临床检验中心 [3]中国中医科学院眼科医院检验科

出　　处：《中华检验医学杂志》2018年第10期742-748,共7页Chinese Journal of Laboratory Medicine

基　　金：北京市医院管理局临床医学发展专项经费资助（ZYLχ201805）;国家临床重点专科建设项目（QTW）

摘　　要：目的探讨C反应蛋白（CRP）正确度验证物质进行多系统定值，并在北京地区进行CRP正确度验证调查。方法在首都医科大学附属北京朝阳医院和首都医科大学附属北京潞河医院检验科组合成10个目前国内最常用CRP检测系统，对已研制的两个浓度的CRP正确度验证物质进行联合定值，采用CRP国际标准物质ERM－DA474/IFCC进行量值传递。首先将ERM－DA474/IFCC稀释成4个浓度水平，用以上10个系统分别测量ERM－DA474/IFCC稀释各水平CRP的浓度值；然后，用认证浓度和测量的浓度值拟合成直线，分别为高、低两个浓度水平的正确度验证物质定值，并评估其定值的不确定度。然后利用此物质在北京地区的42家实验室开展CRP正确度验证调查：将正确度验证物质作为室间质评品，按北京市临检中心室间质评标准程序发放样品，将回报结果采用Excel 2007和SPSS17.0软件进行统计学分析，采用效能函数En，判定定值结果与所有参加实验室的总体均值有无显著差异。结果最终，CRP两个浓度水平正确度验证物质定值及扩展不确定度分别为（109.9±9.4）mg/L和（27.1±2.4）mg/L。北京市正确度验证计划中，定值结果与所有参加实验室的均值无显著差异，效能函数En均小于1。结论本研究采用多个系统联合定值方法为研制的CRP正确度验证物质定值，其定值准确，不确定度小。对于没有公认参考测量方法的CRP，是一种准确可行的方法，适用于北京市正确度验证计划。ObjectiveTo value C-reactive protein （CRP） trueness verification materials and to perform the CRP trueness verification program in Beijing. MethodsThe CRP value of trueness verification materials were assigned by the international reference material ERM DA-474/IFCC, using 10 clinical routine detection systems at departments of clinical laboratory of Beijing Chaoyang and Luhe Hospital Affiliated to Capital Medical University. The calibration curves with 4 ERM DA-474/IFCC dilutions were established and used for value transfer for trueness verification materials of two levels. The uncertainty was also assessed during the process. Then, the trueness verification was performed in the EQA at Beijing Center for Clinical Laboratories （BCCL）among 42 clinical laboratories. The samples were distributed according to BCCL standard operating procedure. The Microsoft Excel 2007 and SPSS 17.0 were used to process the results and the function of efficiency （En） was calculated to verify the difference between the value and the overall mean of all participating laboratories.ResultsThe values and uncertainties of two trueness verification materials of CRP were （109.9±9.4） mg/L and （27.1±2.4） mg/L respectively. The results of trial application of two level trueness verification materials in the EQA at Beijing Center for Clinical Laboratories （BCCL） were satisfied. There were no significant difference between the transfer values from our study and the values from means of all laboratories in Beijing. The function of efficiency （En） was less than 1.ConclusionsThe valueswhich were established by using multiple detection platforms for CRP trueness verification materialswere accurate and the uncertainties were small. This method is a preferably method for CRP value assignment because there was no suitable reference method for CRP measurement till now. Thematerialswere suitable for the trueness verification program for clinical laboratories in Beijing.（Chin J Lab Med, 2018, 41： 742-748）

关 键 词：C反应蛋白质 参考标准 参考值 质量控制 

分 类 号：R446.1[医药卫生—诊断学]