一种唾液快速检测HIV-1/2型抗体试剂的现场评价  

Field evaluation of a new saliva rapid test kit of testing HIV-1/2 antibody

作　　者：刘世亮[1] 丁国伟[1] 米国栋[1] 齐妍[1] 朱新朋[2] 彭庭海[3] 梁富雄[4] 强来英[1] 张桂云[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,北京100050 [2]河南省疾病预防控制中心,郑州450052 [3]湖北省疾病预防控制中心,武汉430079 [4]广西壮族自治区疾病预防控制中心,南宁530021

出　　处：《中国艾滋病性病》2006年第3期196-198,共3页Chinese Journal of Aids & STD

摘　　要：目的对一种唾液快速检测艾滋病病毒Ⅰ/Ⅱ型(HIV-1/2)抗体试剂进行现场评价,考核其现场使用的敏感性和特异性,以及与血液HIV-1/2抗体检测试剂的一致性。方法采集247例已知HIV感染者、1 090例正常献血人员、60例患有其它疾病的患者(包括孕妇、肿瘤患者、一般疾病患者),以及109例HCV感染者和119例未知HIV感染状况的吸毒人员的唾液标本,现场使用Vanguard OMTTM唾液HIV-1/2抗体快速检测试剂盒(CalypteBiomedical生产)进行检测,同时平行采集上述人群的血液标本,使用Vironostika HIV Uni-FormⅡplus O(BioMerieux生产)进行对比测试。结果247例已知HIV感染者中,247例唾液标本HIV-1/2型抗体检测均为阳性。1 259例血液酶联免疫吸附试验(ELISA)检测HIV抗体阴性人群中,1 257例唾液检测为阴性,2例为阳性。119例吸毒人员中,28例血液标本HIV阳性中,唾液标本检出27例。91例HIV阴性中检出阴性90例。该唾液HIV抗体快速检测试剂,敏感性为99.64%,特异性为99.78%。与ELISA检测的一致性为99.75%。结论唾液HIV-1/2型抗体检测试剂与现行的血液ELISA检测结果相近。唾液标本的采集方便而且危险性小,推荐在采血较困难的人群、基层医疗机构、VCT门诊等,可考虑使用唾液HIV-1/2型抗体快速检测试剂进行HIV抗体初筛检测。Objective To evaluate in the field a new salive rapid test kit of testing HIV-1/2 antibody named Vanguard OMTTM HIV-1/2.Methods Paired saliva and serum specimens were collected from 247 HIV positive cases and 1090 blood donors, Sixty cases with others medical conditions, 109 HIV positive cases and 119 cases of unknow HIV status （IDUs） were tested for HIV antibody by using Vanguard OMTTM HIV-1/2 test kits and ELISA. Result Of 247 saliva specimens from HIV cuntibody positive individuals, all showed positive reaction. Of 1259 speimens from the HIV nega- tive group tested by ELISA kit, 2 showed positive reaction by saliva rapid test. Of 119 IDUs tested by ELISA kit, 28 cases were HIV antibody positive and 91 cases were HIV antibody megative, In the former 27 cases were confirmed by saliva test while in the latter 1 cases showed positive reaction by saviva test. The sensitivity of the saliva rapid test was 99.64% and its specificity was 99.78%. In general, the consistent rate of HIV-1/2 antibody screened by saliva rapicl test and ELISA test was 99.75 %. Conclusion The saliva rapid test kits which screened HIV-1/2 antibody of saliva specimens had high sensitivity and specificity and also showed almost the same results tested by serum ELISA test. It was proposed that this saliva rapid test could be introduced in HIV antibody screening.

关 键 词：唾液标本 快速检测试剂 艾滋病病毒Ⅰ/Ⅱ型抗体 

分 类 号：R373.9[医药卫生—病原生物学]