两种化学发光平台肿瘤标志物检测的相关性和一致性研究  

The Correlation and Consistency of Two Chemiluminescence Platforms for Detecting Tumor Markers

作　　者：尚东锋 杨田田 蒋锡娟 SHANG Dongfeng;YANG Tiantian;JIANG Xijuan(Department of Clinical Laboratory,the Third People′s Hospital of Wuxi Huishan District,Wuxi 214000,Jiangsu,China)

机构地区：[1]无锡市惠山区第三人民医院检验科,江苏无锡214000

出　　处：《系统医学》2024年第13期31-34,共4页Systems Medicine

摘　　要：目的评价两种化学发光检测系统对肿瘤标志物检测的相关性和一致性。方法分别使用深圳新产业生物MAGLUMI X3化学发光检测系统和贝克曼UniCel DXI 800化学发光检测系统对肿瘤标志物癌胚抗原(Carcinoembryonic Antigen,CEA)、甲胎蛋白(Alpha Fetoprotein,AFP)、糖类抗原19-9(Carbohydrate Antigen 19-9,CA199)、糖类抗原15-3(Carbohydrate Antigen 15-3,CA153)、糖类抗原12-5(Carbohydrate Antigen 12-5,CA125)、前列腺特异抗原(Total Prostate Specific Antigen,t-PSA)和游离前列腺特异抗原(Free Prostate Specific Antigen,f-PSA)进行检测,参照美国临床实验室标准化委员会EP9-A2文件要求,通过Pearson相关性分析、Passing-Bablok回归分析、Bland-Altman一致性分析评估不同仪器和试剂结果的相关性和一致性。结果两种检测系统在参考范围内,AFP、CEA、CA153、CA199、CA125、f-PSA、t-PSA线性相关系数(r)分别为0.992、0.984、0.982、0.986、0.992、0.990、0.992(P均<0.001),两检测系统显著相关。Passing-Bablok回归分析,两检测系统存在线性关系。Bland-Altman分析表明,两检测系统的一致性良好,相差幅度临床可接受,结果具有临床可互换性。结论深圳新产业生物MAGLUMI X3化学发光免疫分析仪和贝克曼UniCel DXI 800化学发光免疫分析仪检测AFP、CEA、CA125、CA199、CA153、t-PSA和f-PSA的相关性良好,两检测系统一致性较高。Objective To evaluate the correlation and consistency of two chemiluminescence detection systems for de-tecting tumor markers.Methods Tumor markers carcinoembryonic antigen(CEA),alpha fetoprotein(AFP),carbohy-drate antigen 19-9(CA19-9),carbohydrate antigen 15-3(CA153),carbohydrate antigen 12-5(CA125),total prostate specific antigen(t-PSA)and free prostate specific antigen(f-PSA)were detected by Snibe MAGLUMI X3 chemilumi-nescence detection system and Beckman UniCel DXI 800 chemiluminescence detection system,respectively.Accord-ing to the requirements of the American Committee for Clinical Laboratory Standardization EP9-A2 document,the cor-relation and consistency of the results of different instruments and reagents were evaluated by Pearson correlation analysis,regression analysis and Blain-Altman consistency analysis.Results In the reference range of the two detec-tion systems,linear correlation coefficient(r)of AFP,CEA,CA153,CA199,CA125,f-PSA,t-PSA were 0.992,0.984,0.982,0.986,0.992,0.990,0.992(all P<0.001),the two detection systems were significantly correlated.By Passing-Bablok regression analysis,there is a linear relationship between the two detection systems.Bland-Altman analysis showed that the two detection systems had good consistency,the difference amplitude was clinically acceptable,and the results were clinically interchangeable.Conclusion The correlation between the detection of AFP,CEA,CA125,CA199,CA153,t-PSA and f-PSA by Snibe MAGLUMI X3 chemiluminescence immunoanalyzer and Beckman UniCel DXI 800 chemiluminescence immunoanalyzer is good.The consistency of the two detection systems is relatively high.

关 键 词：新产业 贝克曼 化学发光 肿瘤 

分 类 号：R730.4[医药卫生—肿瘤]