国产艾滋病病毒抗体检测试剂临床应用研究

Evaluation of Five Domestic HIV Antibody Detection Reagents in Clinical Application

为了解国产HIV抗体初筛试剂盒的使用现状 ,促进国产HIV抗体初筛试剂盒质量的提高 ,增强我省各实验室HIV抗体检测质量 ,1 999年 1 2月对五种国产试剂进行了临床应用评估。五种国产试剂为参评试剂 ,一种进口试剂为参比试剂 ,同时检测 1 83份标本 ,其中 65份为已知阳性标本和不确定标本 ,1 1 8份为未知标本。进口试剂检出了全部 76份阳性标本 ,敏感性为 1 0 0 % ,国产试剂有 2～ 3份标本未检出 ,敏感性为 96 .1～ 97.3 %。未检出标本主要为弱阳性标本。提示象血站、医院输血科使用检测试剂时须慎重 ,以杜绝漏检。 1 0 4份阴性标本 ,进口试剂有 1份未检出 ,特异性为 99.0 % ;国产试剂有 1～ 6份未检出 ,特异性为 94.2～1 0 0 %。

To evaluate the quality of five domestic enzyme-linked immunosorbent assay (ELISA) kits, study their current status in clinical applications and enhance test quality of in laboratories of our province, 183 serum specimens were detected by five domestic ELISA kits for anti-HIV screening, with an imported kits as reference. Anti-HIV could be detected in all 76 confirmed positive specimens with imported kit, with sensitivities of 100%. But 2-3 specimens were false negative with domestic kits, with sensitivities of 96.1-97.3%. The false negative specimens were all weak positive for anti-HIV. One of the 104 confirmed negative specimens was false positive with the imported kit, with a specificity of 99.0%, and 1-6 specimens were false positive with domestic kits, with specificity of 94.2-100%. The sensitivity of domestic ELISA kits for anti-HIV screening should be improved further to ensure the safety of blood transfusion and the control of AIDS /HIV.