两代酶联免疫试剂在男男性行为人群HIV检测中的应用

目的通过使用第四代与第三代艾滋病病毒(HIV)抗体酶联免疫试剂检测结果及核酸检测结果的比较,评估其在天津市男性性行为人群(MSM)HIV感染筛查中的应用效果。方法对天津市某区自愿咨询检测点进行咨询检测的男男性行为人群用EDTA抗凝管采集血液样品,同时使用两代HIV抗体筛查试剂进行检测,阳性者进行确证检测,两种筛查试剂检测结果均为阴性的样品,采用集合核酸检测方法进行检测。结果共计检测MSM人群血液样本2 065份,共对87份样品进行了确证试验,1 978份HIV抗体筛查阴性样品经核酸检测,有1份集合样品呈阳性。HIV抗体确证试验为阴性和不确定的6份样品,进行单份核酸检测,有4份HIV-1RNA阳性,病毒载量检测结果均符合HIV急性感染特征。此次研究中的MSM人群HIV感染率为4.16%(86/2 065),95%可信区间3.34%～5.12%。发现5例HIV急性感染者,估计该人群年发病率为3.16%,95%可信区间1.01%～7.35%。使用第三代抗体试剂进行筛查时,总费用为148 360元,其敏感性为94.2%(81/86)、特异性为100%,发现HIV感染者的单位成本为1 832.6元。使用第四代抗体试剂进行筛查时,总费用为166 080元,其敏感性为98.8%(85/86)、特异性为99.9%(1 977/1 979),发现HIV感染者的单位成本为1 953.9元。结论此次研究估测该人群的HIV感染年发病率为1.01%～7.35%,提示其高危性行为程度较高。在该人群中,使用第四代试剂筛查时,HIV感染者发现数比使用第三代试剂增加4.9%,发现HIV感染者的单位成本增加6.2%,提示具有推广应用价值。

Study on HIV detection among men who have sex with men in Tianjin

Objective To evaluate the results of the third and the fourth generation HIV ELISA reagents used in screening anti-HIV antibody from MSM in Tianjin,and to compare the results of ELISA with that of nucleic acid.Methods The blood samples were collected from MSM attending VCT clinics with EDTA anticoagulant tubes,which were screened by both reagents.The positive samples were detected by confirmatory test and the negative ones by gathering nucleic acid test.Results A total of 2,065 blood samples were collected,of which 87 samples tested as positive were detected by confirmatory test and 1,978 samples tested as negative were retested by gathering nucleic acid test,of which one was found positive;of the 6 samples tested as negative by HIV-antibody confirmatory test,4 samples were detected as HIV-1 RNA positive.The HIV infection rate was 4.16%(86/2065,95%CI3.34%-5.12%),including 5 individuals in acute stage of HIV infection.The annual infection rate among this population group was 3.16%(95%CI1.01%-7.35%).The screening tests by the third generation HIV ELISA reagents cost a total of 148360 $,the sensitivity and specificity were 94.2%(81/86) and 100% respectively,and unit cost in detecting HIV infected person was 1832.6 $;the screening test by the fourth generation HIV ELISA reagents cost a total of 166080 $,the sensitivity and specificity were 98.8%(85/86) and 99.9%(1977/1979 respectively,and unit cost in detecting HIV infected person was 1953.9 $.Conclusions There is high prevalence of high risk sex behaviors in MSM in Tianjin,with the annual HIV infection rate of 1.01%-7.35%;the HIV infected individuals detected by the fourth generation HIV ELISA reagents increased by 4.9% than those by the third generation reagents,and the unit cost of detecting HIV infected person increased by 6.2%,which demonstrated that the fourth generation HIV ELISA reagents are valuable and should be recommended for extended use.