【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