CEA电化学发光免疫分析法的建立

Establishment of Electrochemiluminescence Immunoassay for CEA

目的建立人癌胚抗原(CEA)的电化学发光免疫分析法(ECLIA)。方法生物素标记的CEA McAb、钌复合物标记配对的CEA McAb、链霉亲和素包被的磁性微粒组成CEA ECLIA试剂,用ECLIA仪检测CEA并做方法学评价。用本法与进口的同类ECLIA试剂对119例结直肠癌、150例肺癌、45例胃癌、32例胰腺癌和34例肝细胞癌患者的血清CEA检测结果进行分析。调查218名志愿者血清CEA正常参考值。结果本法检测CEA的批内CV为1.6%～7.1%,批间CV为2.3%～11.7%,灵敏度为0.2 ng/mL。与CA19-9和AFP无交叉反应。自建ECLIA检测CEA浓度范围为0.2～1000.0ng/mL,正常参考值低于5.6ng/mL。结论自建CEA ECLIA与进口试剂比较(r=0.9641,P<0.05),正常参考范围接近进口同类方法。具备产业化的潜能。

Objective To establish electrochemiluminescence immunoassay（ECLIA） to detect CEA levels in human serum.Methods The CEA monoclonal antibody（McAb） was biotinylated,and the paired CEA McAb was labeled with ruthenium.The microparticles were coated with streptavidin.The CEA levels in 119 patients with intestinal lung cancer,150 lung cancer,45gastro cancer,32 pancreatic cancer,34 primary hepatocellular carcinoma and 218 healthy volunteers were tested by established ECLIA reagent in this study and Roche reagent.Results The results showed that the inter-assay and intra-assay CVs were 1.6 ～7.1% and 2.3～11.7%,respectively.The lower detection limit was 0.2 ng/mL.There was no cross-react with CA199 and AFP.The CEA detection ranges were 0.2 ～1000.0 ng/mL.The detected results with this method were closely corresponded to those of by Roche reagents（r=0.9641,P0.05）.Conclusion The established ECLIA for CEA in this study was specific,sensitive and with a good precision.It may have a industrial potentiality.