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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

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

SnibeBeckmanChemiluminescenceTumor

尚东锋、杨田田、蒋锡娟

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无锡市惠山区第三人民医院检验科,江苏 无锡 214000

新产业 贝克曼 化学发光 肿瘤

2024

系统医学

系统医学

ISSN:
年,卷(期):2024.9(13)