CA50-时间分辨荧光免疫分析试剂盒的制备与评价  

Preparation and evaluation of a time-resolved fluoroimmunoassay kit for CA50 determination

作　　者：杭建峰[1] 吴英松[1] 徐伟文[1] 余伟鸿 黄颖[3] 李明[1] 

机构地区：[1]南方医科大学生物技术学院,广州510515 [2]广州市达瑞抗体工程技术有限公司 [3]中国药品生物制品检定所

出　　处：《中华肿瘤杂志》2007年第3期189-192,共4页Chinese Journal of Oncology

基　　金：广州市重大科技攻关项目（2003U130021）

摘　　要：目的 研制并评价CA50-时间分辨荧光免疫分析（TRFIA）试剂盒。方法 基于TRFIA技术，利用双抗体夹心法制备CA50-TRFIA试剂盒，并进行自制试剂盒的指标评价。检测415份健康人血清，确定CA50-TRFIA试剂盒检测血清CA50的正常值范围。结果 CA50-TRFIA试剂盒的线性测量范围为5～300 U／ml，灵敏性为0．2 U／ml，稳定性为4℃10个月，均优于CA50-放射免疫分析（Rn）试剂盒。与癌胚抗原（CEA）、CA12-5、CA15—3及甲胎蛋白（AFP）均无交叉反应发生，与CA19-9的交叉反应值为0．7U／ml。批内变异系数（CV）均低于10％，批间CV低于15％，符合国家生物制品检定规程的规定。自制CA50-TRFIA试剂盒与CA50-RIA试剂盒的血清CA50检测结果显著相关（r=0．901）。结论 CA50-TRFIA试剂盒具有良好的灵敏性、特异性和准确性，适于临床应用。Objective To prepare a rapid and sensitive diagnostic kit for detection of CA50 based on time-resolved fluoroimmunoassay. Methods A sandwich-TRFIA diagmostic kit was developed using anti-CA50 monoclonal antibody and all parameters of the kit were evaluated. Results The linear measurement range of the kit was （5 - 300） U/ml. The sensitivity was 0.2 U/ml. The intra- and interssay coefficients of variation were 4.3% - 8.2% and 7.7% - 11.2%, respectively. There was no cross-reaction with CEA, CA12-5, CA15-3 and AFP. The cross reactivity with CA19-9 was 0.7 U/ml. The correlation coefficient of detection results of 107 blood samples between this newly developed kit and commercially available CA50 RIA kit was 0. 901. Conclusion This newly developed CA50-TRFIA kit is a valuable test tool for clinical application with even better sensitivity, specificity and accuracy.

关 键 词：CA50 时间分辨荧光免疫分析 试剂盒 诊断 

分 类 号：R686[医药卫生—骨科学]