Objective To analyze and evaluate the clinical application of tumor marker detection kit [ microarray enzyme-linked immunosorbent assay ( Array-ELISA ) ] in determining 6 tumor markers. Methods Electro-chemiluminescence immunoassay ( ECLIA) analyzer was used to detect 6 clinically common tumor markers: alpha fetoprotein (AFP) , carcinoembryonic antigen ( CEA) , prostate specific antigen ( PSA) , carbohydrate antigen 125 (CA125) , carbohydrate antigen 199 ( CA199 ) and carbohydrate antigen 153 ( CA153 ). The receiver operating characteristic(ROC)curve was evaluated. Results There were no significant differences in the positive rates of AFP, CEA, PSA and CA125 by the 2 methods (P > 0. 05 ) , while the positive rates of CA199 and CA153 had statistical significance (P<0.01). The determination results of AFP, CEA, PSA, CA125 and CA199 by the 2 methods showed high total coincidence rate ( > 85% ) , and the total coincidence rate of CA153 was 61. 1%. The correlation was significant [P <0.01, correlation coefficient (r) =0.695-0.960] , and areas under ROC curves of AFP, CEA, PSA, CA125 and CA199 were 0. 62-0. 99. The area under ROC curve of CA153 by Array-ELISA was lower than that of ECLIA in the diagnosis of breast carcinoma. Conclusions Both Array-ELISA and ECLIA show good coincidence in detecting the 6 tumor markers, and Array-ELISA could be introduced for clinical routine examination and screening testing of determining 6 tumor markers.%目的 分析和评价6项肿瘤标志物测定试剂盒[微阵列酶联免疫法(Array-ELISA)]在肿瘤标志物检测中的应用价值.方法 采用Array-ELISA和电化学发光免疫分析法(ECLIA)检测相同标本的6项临床常见肿瘤标志物:甲胎蛋白(AFP)、癌胚抗原(CEA)、前列腺特异性抗原(PSA)、糖类抗原125( CA125)、糖类抗原199( CA199)和糖类抗原153( CA153).采用受试者工作特征(ROC)曲线进行分析.结果 2种方法检测AFP、CEA、PSA和CA125的阳性率差异无统计学意义(P＞0.05),检测CA199和CA153的阳性率差异有统计学意义(P＜0.01).2种方法对AFP、CEA、PSA、CA125和CA199的检测结果总符合率均＞85％,仅CA153的总符合率为61.1％.2种方法对6项肿瘤标志物的检测结果显著相关(P＜0.01),相关系数(r)为0.695 ～ 0.960.2种方法检测AFP、CEA、PSA、CA125和CA199对相关肿瘤诊断的ROC曲线下面积介于0.62 ～0.99之间；用Array-ELISA检测CA153对乳腺癌诊断的ROC曲线下面积低于ECLIA.结论 Array-ELISA与ECLIA对6项肿瘤标志物的检测结果均有良好一致性,可以引入Array-ELISA检测6项肿瘤标志物作为常规体检项目和筛查项目.
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