CEA时间分辨荧光免疫分析的方法学及临床应用评价

Clinical Application and Evaluation of Carcinoembryonic Antigen Detection in Serum by Timed-resolved Fluoroimmunoassay

目的 建立CEA的时间分辨荧光免疫分析 (TRFIA)法 ,并对CEATRFIA方法学及临床应用价值进行评价。方法用稀土离子Eu3+标记CEA单克隆抗体 ,以 96孔微孔板为载体 ,固相夹心法建立CEATRFIA ;通过对 163例恶性肿瘤患者和 5 0 0例正常人血清CEA的测定 ,采用Log Logit函数处理程序处理数据 ;应用临床诊断试验评价方法 ,系统地对CEATRFIA方法学和临床应用价值进行评价。结果 CEATRFIA在精密度、重复性、线性范围和回收率等方面均获得较为满意的结果 ;该方法的敏感度为 5 0 .31% ,特异度为 99.2 0 % ,准确度为 87.18% ,阳性预示值为 95 .35 % ,阴性预示值为 85 .96%。结论 CEATRFIA是 1种新的免疫标记技术 ,具有灵敏度高和稳定性好等优点 。

Objective To evaluate the method and clinical value of serum carcinoembryonic antigen(CEA) detection by time-resolved fluoroimmunoassay(TRFIA).Methods Europium labeled anti CEA monoclonal antibody was used to set up a solid phase sandwich TRFIA for quantification of CEA;163 sera of malignant tumor patients and 500 sera of healthy individuals were analyzed and data were handled by Log Logit method.Results CEA TRFIA had several advantages including high sensitivity,good replicability and a wide working range,the rate of recovery was also good.The sensitivity was 50.31%,the specificity was 99.20%,the accuracy was 87.18%,positive predictive value was 95.35%,negative predictive value was 85.96%.Conclusion CEA TRFIA is a new immunoassay which has high sensitivity and good stability.It is suitable for routine clinical use.