建立联合检测人附睾蛋白4、糖类抗原15-3荧光层析方法  

Establishment of a fluorescent immunochromatographic method for combined detection of human epididymal protein 4 and breast cancer antigen 15-3

作　　者：王云龙[1,2,3,4,5] 李果 李玉林 王继创 程蕾 张怡青 WANG Yun-Long;LI Guo;LI Yu-Lin;WANG Ji-Chuang;CHENG Lei;ZHANG Yi-Qing(School of Life Science,Henan Normal University,Xinxiang 453002,China)

机构地区：[1]河南师范大学生命科学学院,新乡453002 [2]河南省生物工程技术研究中心,郑州450000 [3]郑州职业技术学院,郑州450000 [4]生物标志物定量检测河南省工程实验室,郑州450000 [5]抗体药物开发技术国家地方联合工程实验室,郑州450000

出　　处：《中国免疫学杂志》2020年第4期461-466,共6页Chinese Journal of Immunology

基　　金：河南省科技攻关项目(182102310385)

摘　　要：目的:建立联合检测HE4、CA15-3荧光免疫层析的方法。方法:采用双抗体夹心法与荧光免疫层析相结合,联合检测HE4、CA15-3,并对检测时间、线性范围、最低检出限、精密性等指标进行评价。结果:检测时间15 min,HE4和CA15-3线性范围分别为15.6~1 500 pmol/L和7.8~500 U/ml;最低检出限分别为14.33 pmol/L和5 U/ml;批内与批间精密性均小于15%;准确率均在90%以上;与罗氏电化学发光法平行检测60份临床样本,相关系数均在95%以上。结论:初步建立了定量联合检测血清中HE4、CA15-3的荧光免疫层析检测方法,有较好的临床应用前景。Objective:To establish a combined detection of HE4 and CA15-3 by using fluorescence immunochroma-tography.Methods:Double antibody sandwich method and fluorescence immunochromatography was combined with to detec the HE4 and CA15-3.Then,to evaluated the detection time,the linear range, minimum detection limitsensitivity and precision.Results:The optimal detection time was 15 min,and the linear range of HE4 and CA15-3 was 15.6-1 500 pmol/L and 7.8-500 U/ml,the minimum detection limit was 14.33 pmol/L and 5.00 U/ml,intra-assay precision and inter-assay precision were less than 15%,the accuracy rate above 90%;60 clinical samples were detected in parallel with Roche electrochemiluminescence method,the correlation coefficient of both was above 95%.Conclusion:The experiment,initially established a fluorescence immunochromatographic detection method to a quantitative detection of serum HE4 and CA15-3,which has a promising clinical application.

关 键 词：联合检测 HE4 CA15-3 荧光免疫层析 

分 类 号：R446.6[医药卫生—诊断学]