五种艾滋病病毒抗体诊断试剂临床质量比较

目的 为掌握中国市售艾滋病病毒(HIV)抗体诊断试剂的实际应用状况。方法 对4种国产HIV抗体酶联免疫吸附试验(ELISA)诊断试剂(其中3种为国产双抗原夹心法试剂)和美国Abbott HIV快速法诊断试剂用200份血清盘样品进行了统一测试。200份血清盘标本包括100份经过确认的HIV抗体阳性、弱阳性、阴性标本和100份高危人群的血清标本。初筛阳性和可疑样品再用蛋白印迹法(WB)做确认对比分析。结果 5种试剂的敏感性为90.7％～98.9％,特异性为93.0％～99.1％,假阳性率为0.9％～7.0％,假阴性率为1.2％～9.3％,总符合率为94.5％～97.5％,约登指数为89.5％～95.4％,阳性预示值(PPV)为91.2％～98.7％,阴性预示值(NPV)为93.4％～99.1％。结论 随着中国双抗原ELISA试剂的研制和市场投放使用,HIV抗体诊断试剂内在质量指标虽有所提高,但其漏检率仍需进一步改进。

Quality Comparison of Five Sets of HIV Antibody Test kits in Clinical Applications

Objective To compare the quality of four sets of domestic enzyme - linked immunosorbent assay( ELISA) kits( three of them are double antigen Sandwich ELISA kits for anti-HIV screening)and an imported rapid Abbott reagent for HIV antibody detection, and study their current status in clinical applications. Methods Two hundred sera panel were tested with four sets of domestic ELISA kits and an imported rapid Abbott reagent for anti - HIV screening, including 100 sera panel with confirmed positive, negative of and weak positire anti-HIV and 100 sera panel collected in our laboratory from high risk population. Results The 5 sets of kits had sensitivities ranging from 90.7 % to 98.9 % , specificities from 93.0 % to 99.1 % , false positive rates from 0.9% to 7.0 %, false negative rates from 1.2% to 9.3%, and total consistence rates from 94.5% to 97.5%, Youden's index was 89.5%-95.3% , PPV-91.2% -98.7% and NPV-93.4%-99.1% .Conclusion Quality of domestic ELISA kits including double antigen San witch ELISA kit for anti-HIV screening should be improved further to ensure safety of blood transfusion and control of AIDS/HIV.