间接法和双抗原夹心法抗-HIV初筛试剂质量对比分析  

Comparative analysis of indirect method and dual-antigen sandwich method in screening of reagents for HIV detection

作　　者：袁玲[1] 陈方祥[1] 刘建忠[1] 马贵山[1] 

机构地区：[1]第三军医大学附属大坪医院野战外科研究所输血科,重庆400042

出　　处：《第三军医大学学报》2003年第12期1098-1100,共3页Journal of Third Military Medical University

摘　　要：目的　综合评估间接法和双抗原夹心法人类免疫缺陷病毒 (HIV 1 2 )抗体酶标诊断试剂盒的质量。方法　以 4对 8种试剂 (同一厂家间接法和双抗原夹心法配对 )对 10 0份人血清样品分别进行对比实验 ,阳性结果以蛋白印迹法(WB)确认。结果　间接法的敏感性、功效率和阴性预示值范围分别为 97.97%～ 10 0 % ,93 .49%～ 98.0 4% ,97.0 5 %～10 0 % ,有 2种试剂存在不同程度上的HIV抗体阳性漏检 ,双抗原夹心法的敏感性和阴性预示值均为 10 0 %、功效率值范围为 96.15 %～ 10 0 % ,测试中未发现假阳性。Objective To estimate the quality of HIV 1/2 antibody labeled ELISA Kit made in China by indirect method and dual antigen sandwich method. Methods Eight kits were divided into 4 groups according to the manufacturers (indirect method and dual antigen sandwich method for the same manufacturer in one group) and were used for the determination of 100 serum samples. The positive and suspected positive results were affirmed by Western blot analysis. Results The sensibility, efficacy ratio and NPV range of indirect method were 97.97%～100%, 93.49%～98.04% and 97.05%～100%, respectively, but 2 kits failed to detect the HIV positive sample. The sensibility, efficacy ratio and NPV range of dual antigen sandwich method were 100%, 96.15%～100% and 100% without mis diagnosis. Conclusion Dual antigen sandwich method is better than indirect method in some indexes of quality.

关 键 词：HIV抗体 间接法 双抗原夹心法 质量控制 

分 类 号：R392.11[医药卫生—免疫学] R457.1[医药卫生—基础医学]