【作者】 李秀华； 许四宏； 宋爱京； 聂建辉； 王佑春；

【Author】 LI Xiu-hua,XU Si-hong,SONG AI-jing,NIE Jian-hui,WANG You-chun (National Institute for Control of Pharmaceutical and Biological Products,Beijing 100050,China)

【机构】 中国药品生物制品检定所；

【摘要】 目的对四种国产和三种进口第四代HIV诊断试剂的质量进行评价。方法利用HIV抗体阴性样品库和核酸阳性样品库、BBI阳转血清盘样品等,对四种国产和三种进口第四代试剂的敏感性和特异性、检测HIV-1早期感染的能力进行分析。结果七种第四代试剂的敏感性均为100%(95%CI:99.86～100%),且1份HIV-1感染窗口期样品均检测为阳性,其中1种进口试剂"δ+"值较大(1.0892),其余6种试剂的"δ+"值均比较小(为0.0836～0.3003)。对阴性样品,七种试剂均存在不同程度的假阳性(特异性为97.80～99.60%,"δ-"值为-1.3803和-0.4778)。对BBI阳转血清盘样品,国产试剂的阳转血清相对敏感性系数为-0.500～0,2种进口试剂则为-0.600和-0.700。结论七种试剂均具有较高的敏感性和特异性,第4代HIV试剂用于血液筛查可发现HIV感染窗口期样本,对减少HIV传播的风险有一定的意义。但进口第四代试剂检测HIV-1早期感染的能力强于国产第四代试剂。更多还原

【Abstract】 Objective To evaluate the quality of four domestic and three imported fourth-generation HIV diagnostic reagents.Methods The specificity and sensitivity of these assays were analyzed when testing HIV negative samples and HIV-1 RNA positive samples The relative seroconversion sensitivity index was analyzed when testing BBI seroconversion panels.Results The sensitivity of seven fourth-generation assays were 100%(95%CI:99.86 ~ 100%),and one sample at the window period of HIV-1 infection were detected as positive.Of the seven assays,one imported assay exhibited the relative large"δ+"value(1.0892), and the small"δ+"value were found on the remaining six assays(-0.0836～0.3003).For the samples negative for HIV antibody,varying degrees of false positives were observed on the seven assays(specificity: 97.80～99.60%,"δ-"value:-1.3803～-0.4778).When testing the BBI seroconversion panels,the relative seroconversion sensitivity index of domestic assays were-0.500～0,however,which of imported assays were-0.600 and 0.700.Conclusion The seven reagents exhibited high sensitivity and specificity.The 4th generation HIV assays can be used as blood screening reagents to find the samples at window period of HIV-1 infection,thus indicating the certain meaning in reducing the transmission risk of HIV-1 for fourth-generation HIV diagnostic reagents.However,the better efficiency to detect HIV-1 early infection was observed on the imported assays than on the domestic assays.更多还原