限制性抗原亲和力酶免法用于MSM哨点HIV-1新发感染检测研究  

Performance of limiting-antigen avidity enzyme immunoassay in the detection of recent HIV-1 infection among men who have sex with men in China

作　　者：梁君[1] 高志云[1] 颜浩[1] 张辉[1] 裴丽健[1] 蒋岩[1] 肖瑶[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

出　　处：《中国病毒病杂志》2014年第2期101-105,共5页Chinese Journal of Viral Diseases

基　　金：国家"十二五"艾滋病和病毒性肝炎等重大传染病防治科技重大专项(2012ZX10001001-001-002)

摘　　要：目的获得新一代人类免疫缺陷病毒1型（HIV-1）新发感染检测方法-限制性抗原亲和力酶免法（LAg—avidityEIA，简称LAg）在现场男男性行为者（MSM）哨点人群中新发感染检测应用结果和与现有BED捕获酶免法（BEDCEIA，简称BED）比较的结果。方法用LAg检测2011年14个省（市、自治区）MSM哨点样本，McNermar方法检验LAg与BED新发感染判定结果的一致性，根据发病率公式计算LAg的HIV-1发病率，与已有的BED的HIV-t发病率比较。结果795份纳入新发感染检测的样本，LAg判定新发感染261人（32．83％，261／795），BED判定新发感染323人（40．63％，323／795）。两种方法判定结果一致率87．17％，Kappa值为0．72，McNermar检验两种方法判定结果一致性差异有统计学意义（P〈0．01）。校正后LAg检测HIV-1发病率为3．94％（95％CI：3．32％～4．56％）、BED检测HIV-1发病率为3．49％（95％CI：2．99％～3．99Voo）；不用FRR校正，LAg和BED获得的HIV-1发病率分别为：4．08％（95％CI：3．52％～4．63％）和3．91％（95％CI：3．38％～4．43％），两种方法计算的校正和未校正HIV-1发病率差异无统计学意义，未校正的HIV-1发病率均高于校正的HIV-1发病率，但LAg校正前后HIV-1发病率变化小于BED。结论对于MSM哨点样本，LAg判定新发感染比例低于BED，用国际公布LAg的校正系数计算我国MSM哨点人群HIV-1发病率与我国人群BED校正系数计算我国MSM哨点人群HIV-1发病率结果基本一致。Objective To evaluate the performance of limiting antigen avidity （LAg-Avidity） EIA test in measuring recent HIV-1 infection by comparing with the BED capture enzyme immunoassay （BED-CEIA） . Methods A total of 795 HIV-1 positive samples from 14 AIDS sentinel surveillance cities/areas of China were collected among the population of men who have sex with men （MSM） . Both LAg-avidity EIA and BED CE- IA were used to detect the blood samples at the same time and the consistency between these two assays were adjusted by McNermar method. Results Of all 795 individuals, LAg EIA and BED CEIA detected positive in 261 （32. 830//oo） and 323 （40.63%）, respectively. There was 87.17% consistency between these two meth- ods with Kappa value at 0.72. The adjusted recent HIV-1 infection rates were 3. 94% （95%CI： 3.32%- 4.56%） for LAg EIA and 3.49%（95%CI： 2.99%-3.99%） for BED CEIA. The unadjusted recent HIV-1 infection rates by LAg and BED were 4.08% （95%CI： 3.52%-4.63%） and 3.91% （95%CI： 3.38%- 4.43%）, respectively. There was no statistical difference between the adjusted and unadjusted recent HIV-1 infection rates of these two methods. Conclusions The recent HIV-1 infection rates detected by LAg EIA was lower than that by BED CEIA. There was no significant difference in the adjusted recent HIV-1 infection rates assayed by both LAg EIA and BED CEIA among MSM sentinel surveillance population in China.

关 键 词：限制性抗原亲和力酶免法(LAg) HIV-1新发感染检测方法 HIV-1发病率 校正系数 MSM哨点 

分 类 号：R446.6[医药卫生—诊断学]