A New Method for Ultra-sensitive P24 Antigen Assay Based on Near-infrared Fluorescent Microsphere Immunochromatography

作     者：WANG Qi HOU Mei Ling LIU Li Peng MA Jing ZHANG Xiao Guang ZHOU Zhi Xiang CAO Yu Xi WANG Qi;HOU Mei Ling;LIU Li Peng;MA Jing;ZHANG Xiao Guang;ZHOU Zhi Xiang;CAO Yu Xi

作者机构：Beijing University of TechnologyCollege of Life Science and BioengineeringBeijing 100124China Beijing Runbio Biotechnology Development Co.LtdBeijing 100106China National Institute for Viral Disease Control and PreventionChinese Center for Disease Control and PreventionBeijing 102206China 

出 版 物：《Biomedical and Environmental Sciences》 (生物医学与环境科学（英文版）)

年 卷 期：2020年第33卷第3期

页      面：174-182页

核心收录：

学科分类：0830[工学-环境科学与工程（可授工学、理学、农学学位）] 1004[医学-公共卫生与预防医学(可授医学、理学学位)] 1001[医学-基础医学(可授医学、理学学位)] 100102[医学-免疫学] 10[医学] 

基　　金：supported by the National Natural Science Foundation of China[no.21677006] National Key Research and Development Project[2017YFC1200500]. 

主　　题：Fluorescent microsphere immunochromatography HIV P24 antigen POCT 

摘      要：Objective To develop a rapid,highly sensitive quantitative method for detecting P24 antigen based on near-infrared fluorescent microsphere immunochromatography.Methods First,we prepared a lateral flow assay test strip,and labeled the detection antibody using a fluorescent microsphere.Second,we optimized the antibody labeling conditions.Third,we optimized the detection conditions.Fourth,we created a working curve.Fifth,we conducted a methodological assessment of the established fluorescent microsphere immunochromatography method.Sixty-six clinical samples were tested,and we compared the established fluorescent microsphere immunochromatography with the quantitative ELISA method.Results According to the working curve,the detection limit of the method is 3.4 pg/mL,and the detection range is 3.4 pg/mL to 10 ng/mL.The average intra-assay recovery was 99.6%,and the Coefficient of Variation(CV)was 5.4%–8.6%;the average inter-assay recovery was 97.3%,and the CV was 8.5%–11%.The detection rate of fluorescent microsphere immunochromatography was higher than ELISA method,and had a good correlation with ELISA.Conclusion The P24 antigen quantitative detection method based on near-infrared fluorescent microsphere immunochromatography has the advantages of rapid detection,high sensitivity,and wide detection range;thus,it is suitable for early clinical diagnosis and continuous monitoring of AIDS.