血清糖类抗原153基于磁珠的时间分辨荧光免疫分析试剂的研制  

Development of Serum Carbohydrate Antigen 153 Time Resolved Fluorescence Immunoassay Based on Magnetic Beads

作　　者：韩婷婷 张艺[1] 周彬[1] 范俊[1] 李文新[1] 郭明明[1] HAN Ting-ting;ZHANG Yi;ZHOU Bin;FAN Jun;LI Wen-xin;GUO Ming-ming(Jiangsu Institute of Nuclear Medicine,Wuxi,Jiangsu,214063,China)

机构地区：[1]江苏省原子医学研究所,江苏无锡214063

出　　处：《中国血液流变学杂志》2023年第1期120-123,共4页Chinese Journal of Hemorheology

基　　金：江苏省妇幼健康科研项目(F202033)。

摘　　要：目的在传统的时间分辨荧光免疫分析(time-resolved fluoroimmunoassay,TRFIA)技术基础上,结合生物素-亲和素放大技术和磁性微粒技术优势,建立一项新方法进行血清中糖类抗原153(carbohydrate antigen153,CA153)含量的测定。方法利用磁性微粒表面的链霉亲和素分子与生物素-CA153包被抗体快速高效结合,从而在固相载体磁性微粒表面形成双抗体夹心复合物。并对新方法的各项性能指标进行评价。结果获得的CA153TRFIA线性方程为y=54638x+7052.2,R^(2)=0.9995;该方法的灵敏度为0.48U/mL,批内和批间的变异系数分别为2.09%~5.95%,1.54%~7.15%,平均回收率为94.48%,与其他肿瘤标志物无明显干扰,正常范围参考值为0~35U/mL。用该方法检测乳腺癌与健康体检者血清的CA153结果与化学发光法一致,相关系数为0.9782。结论该方法灵敏度优于传统技术,是TRFIA的一种新方法,反应时间短,操作简单,敏感度、特异性、准确度等均符合临床应用要求。Objective To develop a new method combined with the advantages of biotin-affinity amplification and magnetic particles for serum carbohydrate antigen 153(CA153)determination based on traditional timeresolved fluorescence immunoassay(TRFIA)technology.Methods As the solid carrier,streptavidin on the magnetic particles captured the biotin-CA153 quickly and efficiently.Later,a double antibody sandwich complex was formed on the surface of solid phase carrier.After the method was established,the performance indexes were evaluated.Results The linear equation of CA153 TRIFA was y=54638x+7052.2(R2=0.9995).The sensitivity of the developed method was 0.48 U/mL,and the inner-and intra-variation coefficient was 2.09%-5.95%and 1.54%-7.15%,respectively,and the average recovery rate was 94.48%.There was no obvious interference with other tumor markers.The reference range of CA153 TRFIA was 0-35 U/mL.The results of this method were consistent well with those of chemiluminescence and the correlation coefficient was 0.9782.Conclusion The sensitivity of this method was better than traditional technology.It was a new method of TRFIA,with shorter reaction time,simpler operation,sensitivity,specificity and accuracy,and would meet the clinical application requirements.

关 键 词：时间分辨荧光免疫分析技术 CA153 磁珠 生物素 检测 

分 类 号：R446.6[医药卫生—诊断学]