HIV感染诊断的检测策略评价  

Evaluation of HIV antibodies laboratory testing algorithms

作　　者：沈蕊[1,2] 裴丽健[1] 岳志远[1] 陈兵[1] 邢文革[1] Shen Rui Pei Lijian Yue Zhiyuan Chen Bing Xing Wenge(National Center for AIDS/STD Control and Prevention, China CDC, Beijing 102206, China Chaoyang District Center for Women and Children＇s Health, Beijing 100021 , China)

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,北京102206 [2]北京市朝阳区妇幼保健院,北京100021

出　　处：《中国艾滋病性病》2017年第1期7-9,12,共4页Chinese Journal of Aids & STD

基　　金：北京市科委课题(D161100000416001)~~

摘　　要：目的针对目前艾滋病病毒(HIV)感染诊断的检测策略进行评价。方法应用991份样本(男男性行为者、吸毒人群、丙型肝炎病毒抗体阳性人群、自愿咨询检测人群、近期感染样本)进行评估,将快速检测(RT)和酶联免疫吸附试验(ELISA)进行顺序排列组合,评价单一试剂检测、双试剂检测和三种试剂检测的策略。结果对925份样本进行检测,单一试剂检测策略敏感性96.55%~99.31%,特异性98.84%~99.87%,符合率98.59%~99.35%;双试剂检测策略敏感性96.55%~97.24%,特异性99.74%~100%,符合率99.24%~99.46%;应用三种RT试剂顺序检测策略的敏感性为95.86%,特异性为100%,符合率为99.35%。近期感染样本检测策略:第四代ELISA抗原抗体检测试剂与蛋白印迹试验(WB)组合确证3份阳性、14份不确定;第四代ELISA抗原抗体检测试剂与核酸检测组合检确证22份阳性。结论对评估人群样本检测,应用单试剂检测策略均存在假阴性和假阳性的情况,应用双试剂检测策略特异性增加;三种RT检测方法组合与两种检测方法组合策略比较,特异性方面没有差异,敏感性降低;近期感染样本应用ELISA抗原抗体检测试剂组合核酸检测,检测效率较高,可以有效缩短窗口期。Objective To evaluate human immunodeficiency virus（HIV）antibodies laboratory testing algorithms.Methods 991samples（those infected with HIV recently,MSM,drug users,people with positive hepatitis C,and those seeking services of voluntary counseling and testing）participated in the evaluation.We used rapid tests and enzyme-linked immunosorbent assay to verify the efficiency of algorithms by using a single reagent,two reagents and three reagents for HIV testing.Results The testing strategy of a single reagent showed that the sensitivity of HIV antibody was between 96.55%-99.31%,the specificity between 98.84%-99.87%,with the coincidence rate between 98.59%-99.35%.The testing strategy of two reagents had the sensitivity of 96.55%-97.24%,the specificity of 99.74%-99.74%,with the coincidence of 99.24%-99.24%.The testing strategy of three rapid reagents had the sensitivity of 95.86%,specificity of 100%,with the coincidence of 99.35%.Regarding the detection strategy for the recent infection samples,the combination of ELISA4 and WB confirmed the results of three positive samples,and 14 uncertainties.The combination of ELISA4 and PCR test confirmed the results of 22 positive samples.Conclusion There are false negative and positive results when the single reagent detection is used.The specificity of testing results can be enhanced to about 100% by using two detection algorithms simultaneously.Compared with two detection algorithms,the three kinds of rapid test algorithms have no differences between specificity and sensitivity.To enhance the efficiency of HIV detection and shorten the window period,recent infection samples should be tested by using ELISA antigen and antibody detection assay,and nucleic acid detection simultaneously.

关 键 词：艾滋病病毒 艾滋病病毒抗体 艾滋病病毒抗原 酶联免疫吸附试剂 快速诊断试剂 近期感染 方法学评价 检测策略 

分 类 号：R373.9[医药卫生—病原生物学]