CLIA法和ECLIA法检测7项肿瘤标志物的比较研究  

Comparison research on the determination of 7 tumor markers with CLIA and ECLIA

作　　者：王堃[1] 喻晶[1] 雷旦生[1] 

机构地区：[1]湖北省肿瘤医院检验科,湖北武汉430079

出　　处：《中国卫生检验杂志》2015年第17期2853-2856,共4页Chinese Journal of Health Laboratory Technology

摘　　要：目的评价化学发光免疫分析（CLIA）法与电化学发光免疫分析（ECLIA）法在7项肿瘤标志物检测中的价值。方法采用索灵LSN XL化学发光免疫分析法和罗氏E601电化学发光免疫分析法检测605例肿瘤患者和65例健康体检者的7项标志物：癌胚抗原（CEA）、甲胎蛋白（AFP）、糖类抗原（CA153）、糖类抗原（CA199）、糖类抗原（CA125）、神经元特异性烯醇化酶（NSE）、前列腺特异性抗原（PSA）。对数据进行统计学比较,并采用受试者工作特征（ROC）曲线进行分析。结果 CLIA法和ECLIA法的批内、批间精密度均较好,2种方法检测CEA、AFP、CA125、CA153、NSE、CA199、CA153的阳性率差异均无统计学意义（P〉0.05）,总符合率均〉80%。2种方法对7项肿瘤标志物的检测结果差异有统计学意义（P〈0.01）,相关系数（r）为0.89～1.00,对相关肿瘤诊断的ROC曲线下面积为0.675～0.875。结论CLIA法与ECLIA法对7项肿瘤标志物的检测结果均有良好的一致性,能较好地满足临床需求。Objective To evaluate the clinical application of chemiluminescent immunoassay（ CLIA） and electronic chemiluminescent immunoassay（ ECLIA） in determining 7 tumor markers. Methods Tumor markers（ CEA,AFP,CA153,CA199,CA125,NSE,PSA） of 605 cases cancer patients and 65 healthy persons were tested by LSN XL ECLIA and Roche E601 CLIA methods. The data was statistically analyzed and the receiver operating characteristic（ ROC） curve was used to analyze the data. Results The precision within and between groups of ECLIA and CLIA were all good. There was no statistical significance on the differences in the positive rates of AFP,CEA,PSA,CAl25,CA153,NSE and CA199 by the 2 methods（ P〈0. 05）.The total coincidence rate was more than 80%. The difference on the detection results with these two methods was statistically significant（ P〈0. 01）,the correlation coefficient（ r） was among 0. 89- 1. 00,and the areas under ROC curves of them were among 0. 675- 0. 875. Conclusion Both CLIA and ECLIA show good coincidence in detecting the 7 tumor markers. And both of them can meet the clinical needs well.

关 键 词：化学发光免疫分析法 电化学发光免疫分析法 肿瘤标志物 方法学比较 

分 类 号：R446[医药卫生—诊断学]