人类免疫缺陷病毒1／2型抗体检测酶联免疫试剂盒的研制

采用二聚体合成肽（ＨＩＶ－１ｇｐ４１、ｇｐ１２０、ｐ２４和ＨＩＶ－２ｇｐ３６）包被酶标板条制备成固相抗原，与鼠抗人ＩｇＧ单克隆抗体酶标记物、底物ＴＭＢ及阴阳性参考血清配套制备成ＨＩＶ抗体ＥＩＡ试剂盒，专供检测人血清或血浆ＨＩＶ１／２抗体之用。以荷兰、韩国及万泰试剂作为对照，用该试剂盒对检定所的Ｐａｎｅｌ标准及献血员１５５５０例（其中ＨＣＶ抗体阳性１２８例，ＨＢｓＡｇ阳性４６例）进行检测，四种试剂对检定所Ｐａｎｅｌ标准的１３份阳性血清均呈阳性反应，２８份阴性血清均为阴性；献血员１５５５０例，四种试剂对其中１份血清均呈阳性反应，经Ｗｅｓｔｅｒｎｂｌｏｔ试验证实为阴性，四种试剂的阴性检出率均为９９．９９％。连续制备三批试剂经中国药品生物制品检定所检定，所检项目全部合格；同时委托检定所进行临床考核，４７份阳性血清全部呈阳性反应，１５０份阴性血清全部为阴性。说明该试剂盒具有很好的敏感性和特异性。

ELISA Kit for the Detection of anti-HIV 1/2

We describe here a sandwich immunoassay,in which HIV-1 three dimeric synthietic peptides (gp 120 、gp 41 and p 24 )are combined with an HIV-2 dimeric synthetic peptide,corresponding to the immunodominant envelope epitope,as the coating antigens on micro ELISA plate.This immunoassay has a sensitivity of 100% for anti-HIV-1 (panel standard sera 11 and control sera 32 tested)and 100% for anti-HIV-2 (Panel standard sera 2 and control sera 4 tested).Negativ rate of four different anti-HIV 1/2 kits with human donor plasma was all 99.99%(15578 plasma tested).