血清C-反应蛋白在三种不同检测系统中的方法比对和偏倚评估  

The methods comparison and the bias estimation on the results of serum CRP in three different test systems

作　　者：潘婕[1] 陈雨欣[1] 徐志晔[1] 谭婷婷[1] 沈瀚[1] PAN Jie;CHEN Yu-xin;XU Zhi-ye(Department of Medical Laboratory,Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing 210008,China)

机构地区：[1]南京大学医学院附属鼓楼医院检验科,江苏南京210008

出　　处：《中国医学装备》2020年第8期12-15,共4页China Medical Equipment

基　　金：国家自然青年科学基金(81600201)“线粒体Trx2在血管内皮细胞内调控ASK1的分子机制及其作为动脉粥样硬化防治靶点的研究”。

摘　　要：目的:对3种不同检测系统的C-反应蛋白(CRP)测定结果进行方法比对和偏倚评估,探讨不同系统间CRP测定结果的可比性,为不同系统检验结果的互认和实验室认可提供实验数据。方法:参照美国临床和实验室标准化协会(CLSI)EP9-A2文件要求,以Beckman IMMAGE 800型全自动免疫分析仪作为比较检测系统(X),Beckman OLYMPUS AU5421型全自动生化仪(Y1)和YZD1200型即时检测(POCT)特定蛋白仪(Y2)作为实验检测系统(Y),用患者新鲜血清分别在3种不同检测系统同时检测CRP,对检测结果进行相关性分析。分别绘制实验检测系统与比较检测系统的CRP均值偏倚散点图,评估实验检测系统的测定结果偏倚。以标准误差(SE)≤10%为临床可接受误差,计算实验检测系统(Y)和比较检测系统(X)之间的SE(%),评价3种系统CRP测定结果的可比性。结果:实验检测系统OLYMPUSAU5421型(Y1)和YZD1200型(Y2)与比较检测系统IMMAGE800型(X)对于CRP的检测结果具有较好的相关性(r1=0.9980,r2=0.9934)。两种实验检测系统与比较检测系统相比,当CRP测定结果在200 mg/L以下时,测定数据无明显偏差。两种实验检测系统在不同医学决定水平处CRP的允许误差,除YZD1200型在医学决定水平为10 mg/L时的系统误差>10%外,其他系统误差均<10%。结论:3种不同检测系统检测CRP的结果具有较好的相关性和可比性。Objective: To implement methods comparison and bias estimation for the test results of C-reactive protein(CRP) of three different test systems so as to discuss the comparability of different test system for the test results of CRP, and to provide experimental data for the mutual recognition of test results among different system and laboratory accreditation. Methods: According to the requirements of EP9-A2 document of American Clinical and Laboratory Standards Association(CLSI), Beckman IMMAGE 800 full-automatic immunity analyzer was used as comparative test system(X), and Beckman OLYMPUS AU5421 full-automatic biochemical analyzer(Y1) and YZD1200 POCT immunity analyzer(Y2) were used as experimental test systems(Y). CRP was detected simultaneously by three different test systems with fresh serum of patients, and the correlation analysis of the detection results was conducted. The bias scatter plots of CRP mean between the two experimental test systems and the comparative test system were drawn to assess the bias of the measurement results of the experimental test system. SE%≤10% was used as clinical acceptable error, and the systematic error(SE%) between experimental test system(Y) and comparative test system(X) were calculated, and then the comparability of test results of CRP of three systems was further evaluated. Results: There was a favorable correlation between experimental test system either Olympus AU5421(Y1) or YZD1200(Y2) and comparative test system IMMAGE 800(X)(r1=0.9980, r2=0.9934), respectively. Compared with the comparative test system, there was no significant deviation in the measurement data of two experimental test systems when the CRP value was less than 200 mg/L. The allowable errors of CRP of the two experimental test systems at different medical decision levels were less than 10%, except that of YZD1200 at the medical decision level of 10 mg/L was larger than 10%. Conclusion: The results of CRP by three different test systems have favorable correlation and comparability.

关 键 词：C-反应蛋白(CRP) 方法比对 偏倚 检测系统 

分 类 号：R446[医药卫生—诊断学]