血清糖链抗原-125均相化学发光免疫检测方法的初建  

Development of homogeneous chemiluminescent immunoassy for serum carbohydrate antigen 125

作　　者：赵爽[1,2] 周宇捷[2] 相平[2] 李会强[2] 孙辉 

机构地区：[1]天津市第四中心医院检验科,300140 [2]天津医科大学医学检验学院免疫学教研室,300203 [3]沃克(天津)生物科技有限公司,300384

出　　处：《免疫学杂志》2013年第5期434-437,共4页Immunological Journal

基　　金：天津市滨海新区自主创新重大项目(2011-BK120017)

摘　　要：目的建立血清糖链抗原-125(CA125)光激化学发光免疫分析的检测方法。方法用兔抗人CA125多克隆抗体包被受体微球,1株单克隆抗体用生物素标记,与链霉亲和素包被的供体微球共同组成试剂检测人血清CA125,利用棋盘滴定法确定受体微球及生物素化抗体的最适浓度并进行方法学评价。结果本方法的批内及批间精密度为3.93%～4.40%和5.60%～8.39%;功能灵敏度为3.91 U/ml,分析灵敏度为3.49 U/ml;回收率为105.14%～108.74%;特异性分析中溶血、黄疸和类风湿疾病的干扰率均<10%;本文建立方法的CA125参考值上限为26.53 IU/ml;采用本方法检测50份临床标本结果与Roche Elecsys 2010电化学发光检测法的结果相关系数为0.974。结论本研究建立的方法能够用于定量检测血清CA125,且具有免洗涤、灵敏度强、准确性高、重复性好、便于操作等优点。In this study, we aim to establish and evaluate a Light Induced Chemiluminescent Immunoassay （LICA） for CA125 in human serum. Firstly, the polyelonal antibody of CA125 was coated on receptor particles, the monoclonal antibody of CA125 was labeled with biotin, and the donor particles was coated with streptavidin. All of above were LICA reagents. We optimized test conditions and evaluated the analytical performance. The within-run and the between-run coefficients of variation were 3.93%-4.40% and 5.60%-8.39%, respectively; the analytical sensitivity was 3.49 U/ml and the function sensitivity was 3.91 U/ml; the recovery rate was 105.14%-108.74%. The interference rate of hemolysis, icterus, and rheumatoid diseases were less than 10%; the reference range in serum was less than 26.53 U/ml; the correlation coefficient between 50 clinical samples detection results with home-made and Roche Eleesys 2010 was 0.974. The results indicated the newly developed LICA kit can be used for the quantitative detection of serum CA125, and the method is simple, and the sensitivity and specificity is satisfied the clinical requirements.

关 键 词：糖链抗原125 均相免疫分析 检测方法 光激化学发光 

分 类 号：R446.6[医药卫生—诊断学]