重组抗原捕获酶联免疫试验在云南省哨点监测人群HIV-1新发感染检测中的应用评价  

Application evaluation of a recombinant antigen-based capture enzyme immunoassay in detection of recent HIV-1 infection among the sentinel surveillance population,Yunnan,China

作　　者：梁雯丽 金晓媚[2] 李东民[1] 陈会超[2] 韩孟杰[1] 邢文革[1] 张翠 施玉华[2] 邱茂锋[1] LIANG Wen-li;JIN Xiao-mei;LI Dong-min;CHEN Hui-chao;HAN Meng-jie;XING Wen-ge;ZHANG Cui;SHI Yu-hua;QIU Mao-feng(National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases,National Center for AIDS/STD Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 102206,China)

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传染病溯源预警与智能决策全国重点实验室,北京102206 [2]云南省疾病预防控制中心性病艾滋病防制所

出　　处：《现代预防医学》2024年第10期1860-1864,共5页Modern Preventive Medicine

基　　金：国家“十三五”科技重大专项(2017ZX10201101-002-003,2018ZX10721102-003-002)。

摘　　要：目的探讨HIV-1重组抗原捕获酶联免疫试验(RAg-CEIA)在哨点监测人群HIV-1新发感染检测中的应用价值。方法针对云南省2015年艾滋病哨点监测人群,选择HIV-1抗体确证阳性血浆样本中符合新发感染检测标准的样本,使用HIV-1 RAg-CEIA进行检测。通过标准化光密度(ODn)值识别HIV-1新近感染者,再估算人群的HIV-1新发感染率,比较HIV-1 RAg-CEIA与BED捕获酶联免疫试验(BED-CEIA)和限制性抗原亲和力酶联免疫试验(LAg-Avidity EIA)所得的检测和分析数据。结果纳入研究的哨点监测血浆样本共计51313份,其中HIV-1抗体阳性1255份,应进行新发感染检测373份,实检测253份。使用HIV-1 RAg-CEIA、BED-CEIA和LAg-Avidity EIA检出的HIV-1新近感染样本数分别为88、78和54份,估算哨点监测人群新发感染率分别为0.33%(95%CI:0.26%~0.39%)、0.31%(95%CI:0.24%~0.38%)和0.31%(95%CI:0.22%~0.39%),三者之间两两比较差异无统计学意义(P=0.927)。在6类亚人群中,男男性行为者(MSM)的新发感染率可估算,分别为3.50%(95%CI:2.48%~4.52%)、3.92%(95%CI:2.76%~5.08%)和4.17%(95%CI:2.79%~5.55%),三者之间两两比较差异无统计学意义(P=0.763)。HIV-1 RAg-CEIA与BED-CEIA和LAg-Avidity EIA的样本检测ODn值均呈线性相关(Spearman相关系数分别为0.911、0.755)。结论HIV-1 RAg-CEIA可以有效用于新近感染识别和新发感染率估算,提示该方法在HIV-1新发感染检测中具有良好的应用前景。Objective To explore the application value of a recombinant antigen-based capture enzyme immunoassay(RAg-CEIA)in detection of recent human immunodeficiency virus type 1(HIV-1)infection in the sentinel surveillance population.Methods Among the HIV/AIDS sentinel surveillance population in Yunnan province in 2015,the confirmed HIV-1 antibodies positive plasma specimens matching the detection criteria for recent HIV-1 infection were tested by HIV-1 RAg-CEIA.The recent HIV-1 infection specimens were classified by the normalized optical density(ODn)values,and then the HIV-1 incidence in population were estimated.The detection and analysis data were compared with those by BED capture enzyme immunoassay(BED-CEIA)and limiting antigen avidity enzyme immunoassay(LAg-Avidity EIA),respectively.Results A total of 51313 plasma specimens were tested for HIV antibodies,in which 1255 specimens were HIV-1 antibodies positive.253 out of 373 specimens matching the detection criteria for recent HIV-1 infection were tested by the 3 assays,respectively.By RAg-CEIA,BED-CEIA and LAg-Avidity EIA,88,78 and 54 specimens were classified as recent HIV-1 infections,and the HIV-1 incidence in the sentinel surveillance population was 0.33%(95%CI:0.26%~0.39%),0.31%(95%CI:0.24%~0.38%)and 0.31%(95%CI:0.22%~0.39%),respectively.The differences between the HIV-1 incidence by the 3 assays were not statistically significant(P=0.927).Among the sub-populations,the HIV-1 incidence in men who have sex with men(MSM)were 3.50%(95%CI:2.48%~4.52%),3.92%(95%CI:2.76%~5.08%)and 4.17%(95%CI:2.79%~5.55%),respectively.The differences between the HIV-1 incidence by the 3 assays were not statistically significant(P=0.763).The ODn values by RAg-CEIA were linear correlation with those by BED-CEIA(Spearman’s rank correlation coefficient was 0.911),and those by LAg-Avidity EIA(Spearman’s rank correlation coefficient was 0.755),respectively.Conclusion HIV-1 RAg-CEIA can be effectively used in classification of recent HIV-1 infections and estimation of HIV-1 incidence,ind

关 键 词：人免疫缺陷病毒 新近感染 捕获酶联免疫试验 哨点监测 

分 类 号：R512.91[医药卫生—内科学]