评估第4代HIV酶联免疫法诊断试剂对静脉吸毒者感染窗口期的检测能力  

The fourth HIV generation assay screened out two Infections in window period from IDUs

作　　者：张麒[1] 佐拉[2] 秦光明[3] 孙显光[4] 许文燕[1] 闫红梅[1] 邢文革[1] 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室,北京100050 [2]新疆维吾尔自治区疾病预防控制中心 [3]四川省疾病预防控制中心 [4]贵州省疾病预防控制中心

出　　处：《中华检验医学杂志》2006年第7期631-634,共4页Chinese Journal of Laboratory Medicine

摘　　要：目的应用BBI公司血清抗体阳转盘评价第4代人类免疫缺陷病毒(HIV)酶联免疫法诊断试剂(以下简称第4代试剂)对窗口期感染的检测能力,并应用其从静脉吸毒人群样本中筛查窗口期感染者,从而分析第四代试剂检测临床样本的特异性和敏感性。方法首先应用第3代HIV酶联免疫法诊断试剂筛查BBI血清阳转盘和收集的吸毒人群样本,阳性样本进一步用免疫印迹法确认。再用第4代试剂分别检测阴性和阳性样本,阴性样本中出现阳性反应者,进行p24抗原和HIV RNA病毒载量检测,证实是否为窗口期样本。对证实为窗口期的感染者随访至抗体阳转。结果用第3代试剂检测BBI阳转血清盘,未发现阳性样本;检测静脉吸毒人群样本2629份,发现HIV抗体阳性样本77份,经免疫印迹法(WB)确认均为阳性,阴性样本2552份。第4代试剂可检出BBI阳转血清盘第14天的窗口期样本;在2552份静脉吸毒人群抗体阴性样本中检出2份窗口期样本,一例随访至血清阳转,一例失访。临床检测特异性为99．2％,假阳性率0．8％(95％可信区间0．4％～1．1％)。结论第4代试剂比第3代试剂能够更早地发现HIV感染者,降低窗口期漏检,减少HIV传播。Objective By use of BBI serum panel to evaluate the sensitivity of fourth generation HIV assay for diagnosis of infection in window period, and analyze the clinical specificity and sensitivity of the fourth generation kits in testing IDUs＇serum （plasma） specimens, Methods Firstly,to screen the BBI panel and IDUS＇ specimens by the third generation kits, The positive specimens were confirmed by WB assay, The negative and positive specimens were screened by the fourth generation kits again, The negative specimens being positive in the fourth generation assay were tested respectively P24 antigen and HIV RNA VL to confirm the specimens in ＂window period＂ of detecting HIV antibodies, and followed-up to seroconversion. Results All specimens in BBI panel are HIV antibody negative by third generation kits, 2552 HIV antibody negative specimens were screened out by third generation kits, 77 HIV antibody positive specimens were confirmed by WB assay. The fourth generation kits can screen out window period specimen of fourteenth days in BBI panels. Two infection specimens in window period were screened out from 2552 HIV antibody negative specimens by the fourth generation kits. One can be followed up sero-conversion, and the other was lost in follow up. The clinical specificity and sensitivity of the fourth generation kits were 99.29%, the false positive value was 0. 7% （95% CI 0. 4% - 1.11% ） testing IDUs＇ serum （plasma） specimens. Conclusion The fourth generation kit improve better in sensitivity of diagnosis infection in window period than the third generation kits and can decrease the spread of HIV.

关 键 词：HIV 酶联免疫吸附测定 

分 类 号：R446.6[医药卫生—诊断学]