采用正确度验证物质改进C反应蛋白检测结果一致性  

Improve the consistency of C-reactive protein test results using trueness control material

作　　者：张顺利[1] 吴春颖[2] 马怀安[3] 刘巍[2] 张瑞[1] 岳育红[1] 梁玉芳[1] 赵婷婷[1] 王清涛[1] Zhang Shunli;Wu Chunying;Ma Huaian;Liu Wei;Zhang Rui;Yue Yuhong;Liang Yufang;Zhao Tingting;Wang Qingtao(Beijing Chaoyang Hospital Afiliated to Capital Medical Unitersity,Department of Clinical Laboratory,Bejing 100020,China;Department of Clinical laboratory,Beijing Luhe Hospital Afiliated to Capital Medical University,Beijing 101100,China;Eye Hospital,China Academy of Chinese Medical Sciences,Beijing100040,China)

机构地区：[1]首都医科大学附属北京朝阳医院检验科,北京100020 [2]首都医科大学附属北京潞河医院检验科,北京101100 [3]中国中医科学院眼科医院检验科,北京100040

出　　处：《中华检验医学杂志》2019年第2期146-150,共5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(ZYLX201805);国家临床重点专科建设项目(QTW)。

摘　　要：目的探讨具有互换性C反应蛋白(CRP)的正确度验证物质改进CRP不同检测系统检测结果一致性的效果。方法横断面研究。将经多系统联合定值的高(H)、低(L)两个浓度水平北京市临床检验中心研制的CRP正确度验证物质采用称重法按5L、4L+1H、3L+2H、1L+4H、5H分别配成5个浓度的校准点,用这5个浓度点分别代替原厂校准品校准德赛、利德曼、西门子和罗氏四个国内外不同试剂品牌的CRP检测系统,然后比校准前后这四个检测系统对21份患者血清以及国际临床化学协会(IFCC)的CRP国际标准物质ERMDA-474的检测测结果的差异,以上每个样本均逐次检测2次。结果校准后21份患者系统间样本均值变异系数(CV)中位值从校准前的19.33%下降到2.92%,小于基于生物学变异度导出的最优CV(CV=10.6%)。以德赛为对照系统,其他检测系统作为比较系统,校准前所得的斜率范围为0.90~1.09,校准后为0.93~0.96,斜率更接近1。以ERM-DA474/IFCC作为正确度验证物质时,校准前3个系统2次检测均值的绝对偏倚为3.08^-11.07mg/L,校准后为-0.52^-2.97mg/L,绝对偏倚接近其物质本身定值不确定度(2.5mg/L)。结论利用研制的CRP两个浓度正确度验证物质采用称重法配制5个线性点代替厂家校准品去校准CRP的常规检测系统后,各检测系统间的变异系数减小了,正确度提高了。该物质的推广应用,可能会有效提高CRP各检测系统检测结果一致性和准确性。Objective To explore the CRP harmonization by calibration using commutable trueness verification materials.MethodsHigh and low level of CRP concentrations trueness verification materials(H and L)were prepared by Beijing center for clinical laboratories.Thesetrueness verification materials were diluted to 5 calibration points(5L,4L+1H,3L+2H,1L+4H,5H)by weighing method,respectively.These 5 points were used to calibrate four different brands of CRP detection system(Diasys,Leadman,Siemens and Roche)instead of the original procedure.Sera from 21 patients and the international standard ERM DA-474/IFCC were used to compare harmonization and trueness after calibration.Each sample above was measured twice.ResultsAfter calibration,the median of CV was reduced from 19.33%to 2.92%among 21 patient samples,less than the optimal CV based on biological variability(CV=10.6%).Compared with Desai,the slopes were closer to 1 from 0.90-1.09 to 0.93-0.96 after calibration.Meanwhile,if ERM-DA474/IFCC was used as the trueness verification materials,the absolute bias wasreduced from 3.08-11.07 mg/L to 0.52-2.97 mg/L which was close to theuncertainty of itself(2.5 mg/L).ConclusionsAfterthe calibration which contained five linear concentration points of CRP trueness verification materials by weighing method,both harmonization and trueness of CRP were improved.

关 键 词：C反应蛋白质 校准 参考标准 结果可重复性 

分 类 号：R446.1[医药卫生—诊断学]