GENSCREENULTRA HIV抗原抗体酶联免疫诊断试剂盒的敏感性评价

Sensitivity evaluation of GENSCREEN~ULTRA HIV Ag-Ab kit

目的评价BIO-RAD公司开发研制的人类免疫缺陷病毒（HIV1＋2）抗原抗体酶联免疫诊断试剂盒（GENSCREEN~ ULTRA HIVAg-Ab）,对不同来源样本检测的敏感性。方法以法国生物梅里埃公司生产的HIV1＋2抗原/抗体ELISA检测试剂为参比试剂,分别使用评价试剂和参比试剂检测621例样本,分析两种试剂检测HIV抗原/抗体的敏感性。结果评价试剂和参比试剂检测502份HIV感染者/AIDS患者临床血浆标本均为阳性,符合率为100%,敏感性为100%。评价试剂和参比试剂检测92份HIV分离培养上清液,评价试剂检出89份阳性、参比试剂检出31份阳性,表明评价试剂检测HIV-1p24抗原的敏感性高于参比试剂。另外,又检测了27份HIV抗原系列稀释样本,计算出评价试剂检测HIV抗原的敏感性是参比试剂的4～8倍。结论评价试剂检测HIV抗体的效果与参比试剂相同,检测HIV-1p24抗原的敏感性高于参比试剂。

Objective To evaluate the sensitivity of GENSCREEN ULTRA HIV Ag-Ab kit made by BIO-RAD for detecting different samples.Methods Vironostika HIV Uni-Form Ⅱ Ag/Ab was chosen as reference which was made by Biomerieux.621 samples were tested with prepared kit and reference kit.And then,the difference in sensitivities to detect HIV Ag/Ab between the prepared kit and the reference kit was analyzed.Results The 502 serum samples taken from HIV-infected people or AIDS patients were all HIV positive by using the prepared kit and the reference kit,with a consistence rate of 100% and sensitivity of 100%.To test HIV P24 antigen 92 HIV culture supernatant samples were detected by using the two kits,of which 89 samples were positive by the prepared kit and 31 samples were positive by the reference kit,indicating that the sensitivity of the prepared kit was higher than that of the reference kit in detecting HIV Ag.Additionally,by testing HIV P24 antigen with 27 serial diluted samples it was calculated that the sensitivity of the prepared kit was 4-8 times higher than that of the reference kit in detecting HIV Ag accurately.Conclusions Compared with the reference kit,the prepared kit has the same effect in detecting HIV Ab and higher sensitivity in detecting HIV Ag.