电化学发光法和直接化学发光法测定12项肿瘤标志物指标的相关性和一致性评价  

Correlation and consistency evaluation between electrochemiluminescence and direct chemiluminescence in detecting 12 tumor markers

作　　者：马淼 刘杰 马瑞敏[1] 李萍燕[1] 鲁静 许惠文 于丹葳 张国军[1] Ma Miao;Liu Jie;Ma Ruimin;Li Pingyan;Lu Jing;Xu Huiwen;Yu Danwei;Zhang Guojun(Laboratory Diagnosis Center,Beijing Tiantan Hospital,Capital Medical University/Beijing Engineering Research Center of Immunological Reagents Clinical Research/NMPA Key Laboratory for Quality Control of In Vitro Diagnostics,Beijing 100070,China)

机构地区：[1]首都医科大学附属北京天坛医院实验诊断中心、北京市免疫试剂临床工程技术研究中心、国家药监局体外诊断质量控制重点实验室,北京100070

出　　处：《中国医学装备》2024年第5期20-25,共6页China Medical Equipment

基　　金：北京市高层次公共卫生技术人才培养计划(2022-2-013)。

摘　　要：目的:评估电化学发光法和直接化学发光法测定12项肿瘤标志物的相关性和一致性。方法:选取2023年3-8月首都医科大学附属北京天坛医院体检血清标本2426例,在12项肿瘤标志物中甲胎蛋白(AFP)446例、癌胚抗原(CEA)284例、糖类抗原72-4(CA72-4)289例、糖类抗原19-9(CA19-9)87例、糖类抗原125(CA125)205例、糖类抗原15-3(CA15-3)216例、总前列腺特异性抗原(TPSA)292例、游离前列腺特异性抗原(FPSA)292例、细胞角蛋白19片段(Cyfra21-1)84例、神经元特异性烯醇化酶(NSE)84例、鳞状细胞癌相关抗原(SCC)84例、胃泌素释放肽前体(PROGrp)63例。分别采用电化学发光法和直接化学发光法对12项肿瘤标志物指标进行检测,分析两种检测方法的相关性与及一致性。结果:Pearson和Spearman相关性分析显示,电化学发光和直接化学发光法检测肿瘤标志物的AFP、CEA、CA72-4、CA19-9、CA125、CA15-3、TPSA、FPSA、Cyfra21-1、NSE、SCC和PROGrp12项指标均具有显著正相关性(r=0.971、0.934、0.945、0.975、0.900、0.948、0.994、0.984、0.982、0.828、0.879、0.922,P<0.05);两种方法检测总符合率分别为98.21%、98.24%、98.27%、98.85%、97.07%、99.54%、99.66%、99.32%、92.86%、92.86%、95.24%和96.83%,除CA15-3和NSE因数据原因无法计算Kappa值外,其余均有一致性(Kappa=0.848、0.728、0.930、0.794、0.485、0.887、0.664、0.540、0.477、0.652,P<0.05)。结论:电化学发光法和直接化学发光法检测肿瘤标志物中AFP、CA72-4、CA19-9、TPSA相关性及一致性较好,CEA、CA125、FPSA、Cyfra21-1、SCC、PROGrp相关性较好,但一致性一般,CA15-3、NSE相关性较好。临床在参考实验室检测结果时应注意检测方法的不同可能存在着结果差异。Objective:To assess the correlation and consistency of electrochemiluminescence and direct chemiluminescence in detecting 12 tumor markers.Methods:A total of 2426 serum specimens were selected from the physical examination in Beijing Tiantan Hospital,Capital Medical University from March to August 2023.These specimens included 446cases for alpha fetoprotein(AFP),284 cases for carcinoembryonic antigen(CEA),289 cases for carbohydrate antigen 72-4(CA72-4),87 cases for carbohydrate antigen 19-9(CA19-9),205 cases for carbohydrate antigen 125(CA-125),216 cases for carbohydrate antigen 15-3(CA 15-3),292 cases for total prostate specific antigen(TPSA),292 cases for free prostate specific antigen(FPSA),84 cases for serum cytokeratin 19 fragment(Cyfra21-1),84 cases for neuron specific enolase(NSE),84 cases for squamous cell carcinoma associated antigen(SCC)and 63 cases for pro-gastrinreleasing peptide(PROGrp).The electrochemiluminescence and direct chemiluminescence methods were respectively used to detect the above 12 indexes,and then,the correlation and consistency between the two detection methods were analyzed.Results:The results of Pearson and Spearman correlation analysis showed that there were significantly positive correlations between electrochemiluminescence and direct chemiluminescence methods in detecting 12tumor indexes(AFP,CEA,CA72-4,CA19-9,CA125,CA15-3,TPSA,FPSA,Cyfra21-1,NSE,SCC and PROGrp)(r=0.971,0.934,0.945,0.975,0.900,0.948,0.994,0.984,0.982,0.828,0.879,0.922,P<0.05),respectively.The total coincidence rates between the two methods were respectively 98.21%,98.24%,98.27%,98.85%,97.07%,99.54%,99.66%,99.32%,92.86%,92.86%,95.24%and 96.83%.There were consistencies between electrochemiluminescence and direct chemiluminescence methods for 10 indexes excepted CA15-3 and NSE that could not calculate Kappa values due to data reasons(Kappa=0.848,0.728,0.930,0.794,0.485,0.887,0.664,0.540,0.477,0.652,P<0.05),respectively.Conclusion:In the detections of electrochemiluminescence and direct chemiluminescence methods for

关 键 词：肿瘤标志物 电化学发光 直接化学发光 相关性 一致性 

分 类 号：R197.39[医药卫生—卫生事业管理]