CAJ | 학술논문

目的对4种国产和3种进口第4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4种国产和3种进口第4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 7种第4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“8+”值较大(1.0892),其余6种试剂的“δ+”值均比较小(0.0836 ～0.3003).对阴性样品,7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 -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 7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4代试剂检测HIV-1早期感染的能力强于国产第4代试剂.
목적 대4충국산화3충진구제4대HIV진단시제적질량진행평개.방법 이용HIV항체음성양품고화핵산양성양품고、BBI양전혈청반양품등,대4충국산화3충진구제4대시제적민감성화특이성、검측HIV-1조기감염적능력진행분석.결과 7충제4대시제적민감성균위100％ (95％ CI:99.86％～100％),차1빈HIV-1감염창구기양품균검측위양성,기중1충진구시제“8+”치교대(1.0892),기여6충시제적“δ+”치균비교소(0.0836 ～0.3003).대음성양품,7충시제균존재불동정도적가양성(특이성위97.80％～ 99.60％,“δ-”치위-1.3803 -0.4778).대BBI양전혈청반양품,국산시제적양전혈청상대민감성계수위-0.500～0,2충진구시제칙위-0.600화-0.700.결론 7충시제균구유교고적민감성화특이성,제4대HIV시제용우혈액사사가발현HIV감염창구기양본,대감소HIV전파적풍험유일정적의의.단진구제4대시제검측HIV-1조기감염적능력강우국산제4대시제.
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 4th-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 to -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.