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目的利用时间分辨免疫荧光分析(TRFIA)技术,建立一种人血清癌胚抗原(CEA)的快速全自动检测方法并研制其诊断试剂。方法采用双抗体夹心法(用1株抗CEA的mAb M86160M用于包被微孔板,另1株抗CEA的mAbM86110M用于标记铕)建立CEA-TRFIA,增强液采用β-二酮体为主的发光增强系统。结果CEA-TRFIA的线性测量范围为(1~560)μg/L,分析的灵敏度为0.28μg/L,批内和批间的变异系数(CV)分别为7.2%~8.6%和8.9%~13.2%。与AFP、CA12-5、CA19-9和白蛋白均无交叉反应,与CA15-3的交叉反应值为1.62μg/L。将1000份血清标本用本法与国外罗氏化学发光试剂盒同时检测,其相关系数(r)为0.946。结论CEA-TRFIA的各项指标均达到临床检测的要求,可替代国外同类检测试剂盒,用于临床血清CEA水平的测定。
Objective To establish a rapid and automatic method for the detection of human serum carcinoembryonic antigen (CEA) and to develop its diagnostic reagent by time-resolved immunofluorescence assay (TRFIA). Methods CEA-TRFIA was established by double-antibody sandwich method (one mAb M86160M against CEA was used to coat the microplate and the other one was used to label europium). The enhanced liquid was mainly β-diketone The luminous enhancement system. Results The linearity of CEA-TRFIA ranged from (1 ~ 560) μg / L with a sensitivity of 0.28 μg / L. The coefficient of variation (CV) between the two groups was 7.2% -8.6% and 8.9% ~ 13.2 %. No cross-reaction with AFP, CA12-5, CA19-9 and albumin, cross-reaction with CA15-3 was 1.62μg / L. 1000 serum samples with this method and Roche chemiluminescence kit simultaneously detected, the correlation coefficient (r) was 0.946. Conclusion The CEA-TRFIA indicators meet the clinical testing requirements, can replace the foreign similar test kit for the determination of clinical serum CEA levels.