HIV-1新发感染快速检测方法的建立与初步评价  

Development and preliminary assessment of a rapid test for detection of HIV-1 incidence

作　　者：颜浩[1] 高志云[1,2] 张桂云[1] 冯霞[1] 邱茂锋[1] 张誌 吴丽金 蒋岩[1] 

机构地区：[1]中国疾病预防控制中心性病艾滋病预防控制中心参比实验室,北京102206 [2]阿北医科大学,石家庄050017 [3]北京金豪制药股份有限公司,北京100176

出　　处：《中国艾滋病性病》2014年第6期394-397,共4页Chinese Journal of Aids & STD

基　　金：国家科技重大专项(2013ZX10001-001)~~

摘　　要：目的建立用于I型艾滋病病毒(HIV-1)新发感染检测的斑点金免疫渗滤快速检测方法,并研究其可行性及适用性。方法以特定浓度的HIV-1多亚型重组gp41抗原作为探针,包被硝酸纤维素膜,胶体金标记的抗人IgG作为显色试剂,建立新发感染的快速检测方法。比较该方法与BED捕获酶联法、限制性抗原亲和力方法的一致性。结果采用已知阳转时间的样本用于快速检测方法的建立,检测5例已知感染时间的样本的结果全部正确。分别用3种方法检测90例样本,快速检测方法与BED方法的符合率为88.9%(80/90),与亲和力方法的符合率为94.4%(85/90),快速检测方法与这两种方法检测结果差异均无统计学意义(P>0.05)。结论斑点金免疫渗滤法检测HIV-1新发感染具有快速、简便、经济、直观的特点,可节省检测时间和成本,提高检测效率,具有良好的适用性。Objective To develop a dot immunogold filtration assay （DIGFA） for rapid testing of new HIV-1 infection and study its feasibility and applicability. Methods Nitrocellulose membranes were coated by a multisubtype gp41 recombinant protein with certain concentration and gold-labeled anti-human IgG conjugate was used as a detection antibody, by which the DIGFA for detection of new HIV-1 infection was developed. The concordance of DIGFA with BED-CEIA and LAg-Avidity EIA were evaluated. Results Specimens with certain seroconversion date were used for development of the rapid assay. The testing results of 5 specimens with known seroconversion date by DIG- FA were all correct. Ninety specimens were tested by 3 assays. The coincidence rate between DIGFA and BED assay was 88.9% （80/90）, and 94.4% （85/90） for DIGFA and LAg-Avidity EIA. There were no statistical differences among them （P〉0.05）. Conclusion The DIGFA for detection of HIV-1 incidence is rapid, convenient, economical and visualized, and could be a cost-effective and high efficient method with satisfactory applicability.

关 键 词：艾滋病病毒新发感染 快速检测 斑点金免疫渗滤试验 BED捕获酶联法 限制性抗原亲和力方法 

分 类 号：R373.9[医药卫生—病原生物学]