艾滋病病毒抗体初筛诊断试剂临床质量评估

Clinical quality evaluation of five ELISA kits for HIV screening test

目的:了解目前市场供应的艾滋病病毒(HIV)抗体初筛试剂的质量及使用情况。方法:对5种HIV抗体酶联免疫吸附试验(ELISA)诊断试剂用200份血清样品进行统一测试。200份血清标本包括100份经过确认的HIV抗体阳性、弱阳性、阴性标本及100份高危人群血清标本初筛阳性或可疑标本再用免疫印迹法(WB)做确认对比分析。结果:5种参评试剂的敏感性为96.88％～100.00％,特异性为97.02％～100.00％,假阳性率为0～2.98％,假阴性率为0～3.13％,功效率为97.00％～100.00％,阳性预测值为86.11％～100.00％,阴性预测值为99.39％～100.00％。结论:随着第三代ELISA抗体诊断试剂的发展,试剂的质量较之以前已有了明显的提高。

Objective: To evaluate the clinical quality of five kinds ELISA kits for HIV antibody test. Methods: 100 serum samples confirmed as positive or negative by WB were tested with all these five ELISA kits at the same time, among them 50 samples were supplied by National AIDS Reference Lab, 50 samples were supplied by local lab, and the other 100 samples came from the high risk groups. Results; The sensitivity of five kinds kits different is from 96. 88% to 100%, specificities are from 97. 02% to 100%, false positive proportions are from 0 to 2. 98%, false negative proportions from 0 to 3. 13%, test powers are from 97% to 100%, positive predictive values from are 86. 11% to 100% , negative predictive values are from 99. 39% to 100%. Conclusion: With the development of the third generation ELISA kits, the clinical quality of them have been improved obviously.