测定癌胚抗原的吖啶酯化学发光免疫分析方法的建立

目的建立一种定量测定血清中癌胚抗原（CEA）含量的检测方法。方法根据双抗体夹心法实验原理,利用吖啶酯化学发光免疫分析技术-结合生物素-亲和素磁颗粒分离技术。结果方法的最低检测限为0.2ng/mL,线性范围为2.2~360ng/mL,批内变异为1.9%~2.2%,总变异为6.5%~8.1%,与ROCHE公司的癌胚抗原检测试剂盒（电化学发光法）测定结果的拟合方程为Y=0.9969X＋0.6168,相关系数为r=0.9921。结论本方法的各项指标均满足临床检测的要求,适合临床推广应用。

Establishment of Acridinium Ester-Chemiluminescence Immunoassay Method for the Determination of Carcinoembryonic Antigen

Objective To establish a quantitative detection method for determination of serum carcinoembryoni- cantigen levels. Methods Based on the principle of double antibody sandwich method, the acridinium ester chemiluminescence immunoassay was developed by using bridged avidin-biotin technique. Results The lowest detection limit of assay was 0.2 ng/mL. The linear range was 2.2 - 360 ng/mL and batch variation was 1.9% 2.2%. The total variance was 6.5% -8.1%. The test results by this assay and ROCHE varcinoembryonic antigen assay Kit were linear correlation （ Y=0. 9969X ＋0. 6168, r =0.9921 ）. Conclusion The assay devel- oped in this study might meet the requirements of clinical test and are suitable for clinical application.