第4代HIV抗原抗体联合检测试剂的评价  

Evaluation of the fourth generation assay for the simultaneous detection of HIV antibody and antigen

作　　者：许四宏[1] 李秀华[1] 宋爱京[1] 李敬云[2] 鲍作仪[2] 貌盼勇[3] 王佑春[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]中国人民解放军艾滋病确认实验室 [3]解放军302医院

出　　处：《中国输血杂志》2006年第3期188-191,共4页Chinese Journal of Blood Transfusion

基　　金：国家十五攻关课题资助(编号2004BA71907)

摘　　要：目的评价HIV（1＋2）抗原抗体联合检测试剂，了解其是否适合于血液筛查。方法用HIV抗原抗体联合检测试剂和第3代HIV抗体检测试剂平行检测HIV感染或疑似感染样本205份、吸毒人群样本1486份、有既往献血史人群样本427份、献血和献浆人群样本7237份和丙型肝炎患者样本176份，对两种试剂检测结果不一致样本进行HIV p24抗原或RNA的检测，并分析其特异性和灵敏度。结果联合检测试剂检测HIV p24抗原的分析灵敏度为（2．5～5．0）U／ml，检测HIV抗体的分析灵敏度与第3代HIV抗体检测试剂相当。共检测出8996份HIV抗体阴性样本和503份HIV抗体阳性样本，与第3代试剂相比其特异为99．67％，灵敏度为100％，而且2份HIV感染“窗口期”样本也能检出。结论该试剂在增加HIVp24抗原检测的情况下，对HIV抗体检测的特异性和敏感性没有降低，可用于血液筛查以减少“窗口期”样本传播HIV的风险。Objective To evaluate the fourth generation assay for simultaneous detection of HIV antibody and antigen and check whether it is appropriate for screening the donated blood. Methods HIV antibody and antigen panels were tested with the fourth generation assay. Two hundred and five specimens from patients infected with HIV or suspected infection, 1486 specimens from drug addicts, 427 specimens from population with a history of blood donation,7237 specimens from blood or plasma donors and 176 specimens from patients infected with HCV were tested with both the fourth and the third generation assays. If the results were inconsistent, the specimen would be tested with assays for detecting HIV p24 antigen or RNA. The sensitivity and specificity of the fourth generation assay were compared with the third one. Results The analytic sensitivity for detection of HIV antigen was in the range of （2.5-5.0 ）U/ml, and the analytic sensitivity for detection of HIV antibody was equal to the third generation assay. The specificity was 99.67% when testing 8996 HIV antibody negative specimens and sensitivity was 100% when detecting 503 HIV antibody positive samples. Two specimens at window period of HIV infection, which were missed by the third generation assay, were detected with the fourth generation assay. Conclusion The sensitivity and specificity of the fourth generation assay in the detection of HIV antibody were not reduced. Meanwhile this assay can detect HIV infection during window period so that the potential risk of HIV transmission through blood at window period could be reduced if this assay is used in blood screening.

关 键 词：人类免疫缺陷病毒 抗原 抗体 “窗口期” HIV检测 

分 类 号：R446.62[医药卫生—诊断学] R512.91[医药卫生—临床医学]