男男性行为人群血液与尿液快速HIV-1抗体检测效力分析  

Performance of rapid tests for HIV-1 antibody detection in paired serum and urine specimens of men who have sex with men

作　　者：李佳[1] 辛若雷[1] 孙伟东[1] 张琴[1] 贺淑芳[1] 李洁[1] 卢红艳[1] Li Jia;Xin Ruolei;Sun Weidong;Zhang Qin;He Shufang;Li Jie;Lu Hongyan(Institute of STD/AIDS Prevention and Control,Beijing Research Center for Preventive Medicine,Beijing Center for Disease Prevention and Control,Beijing 100013,China)

机构地区：[1]北京市疾病预防控制中心 北京市预防医学研究中心 性病艾滋病防治所,100013

出　　处：《中华微生物学和免疫学杂志》2020年第10期753-756,共4页Chinese Journal of Microbiology and Immunology

基　　金：北京市疾病预防控制中心、北京市预防医学研究中心科研培育专项(2019-BJYJ-12)。

摘　　要：目的比较HIV-1抗体血液与尿液快速检测试剂在男男性行为人群(men who have sex with men,MSM)中的检测性能,探讨北京市艾滋病防控的适宜技术。方法在北京市疾病预防控制中心艾滋病门诊招募MSM,使用Alere Determine HIV-1/2人类免疫缺陷病毒(HIV)1+2型抗体诊断试剂盒(胶体硒法,A试剂盒)、万泰生物HIV-1尿液抗体检测试剂盒(胶体金法,B试剂盒)和上海英旻泰公司(IMT)HIV-1/2免疫印迹试剂盒(Western blot,WB法,C试剂盒)分别进行检测。统计分析HIV-1抗体血液与尿液快速检测试剂在MSM中的敏感性、特异性,比较与WB检测结果的一致率。结果874例MSM中HIV抗体阳性447例(51.14%),阴性427例。A试剂盒漏检1例阳性病例,B试剂盒漏检23例阳性病例,A试剂盒的检出率高于B试剂盒。以C试剂盒为参照,A和B试剂盒的检测敏感性分别为99.78%和94.85%,特异性均为100%,总体符合率分别为99.89%(Kappa=0.998)、97.37%(Kappa=0.947)。结论尿液快速检测试剂敏感性不如血液,但是采样方便、安全性高、可及性强,更适合自我检测,建议在MSM中推广尿液快速检测用于HIV-1抗体筛查检测。Objective To compare the performance of rapid tests for HIV-1 antibody detection in serum and urine specimens of men who have sex with men(MSM)for investigating suitable technology in the prevention and control of AIDS in Beijing.Methods A total of 874 cases of MSM were recruited in the AIDS clinic of Beijing Center for Disease Prevention and Control.HIV-1/2 antibody rapid test kit(Kit A,Alere Determine),urine HIV-1 antibody rapid test kit(Kit B,Wantai Biological Pharmacy)and HIV-1/2 antibody Western blot kit(Kit C,IMT)were used for antibody detection.The sensitivity,specificity and consistency of the three rapid test kits for HIV-1 antibody detection in serum and urine specimens were analyzed.Results Among the 874 cases of MSM,447 were positive for HIV-1 antibody(51.14%)and 427 were negative.One false negative result occurred by using Kit A and 23 by using Kit B.Taking Kit C as reference,the sensitivity of Kit A and Kit B was 99.78%and 94.85%,respectively;the specificity of both was 100%;the overall consistency was 99.89%(Kappa=0.998)and 97.37%(Kappa=0.947),respectively.Conclusions Although the sensitivity of urine rapid test kit was not as sensitive as serum rapid test kit,it was more suitable for self-test due to its convenience in sampling,high safety and high accessibility.It was suggested that urine rapid test kit should be popularized in MSM population for HIV-1 antibody screening.

关 键 词：男男性行为 HIV-1 快速检测 尿液 

分 类 号：R512.91[医药卫生—内科学]