6种艾滋病病毒抗体初筛试剂质量评估

目的评估国内现行使用的部分HIV抗体ELISA试剂质量.方法 5种国产HIV-1/2 ELISA试剂用200份血清样品(其中已知结果血清和未知结果血清各100份)、进口试剂Vironostika(R)HIV Uni-FormⅡ plusO用其中未知结果的100份血清分别进行对比测试,初筛阳性和可疑血清用蛋白印迹(WB)确认.结果 6种试剂的敏感性、功效率和NPV值范围为90.14%～100%、96.5%～100%和94.85%～100%;其中4种试剂的特异性和PPV值均为100%,测试中未发现假阳性;另2种试剂特异性均为97.67%,假阳性率均为2.33%,PPV值分别为95.89 %和95.71%;除进口试剂Vironostika外,5种国产试剂均存在不同程度的HIV抗体阳性漏检,其漏检率分别为9.86%、4.23%、1.41%、7.04%、5.63%.结论 6种被评估试剂中,试剂Vironostika质量居第一,试剂B次之,余4种再次之.

Quality evaluation of six ELISA kits for human immunodeficiency virus antibodies

Objective: To assess the quality of five domestic ELISA kits (called A. B. C. D. E) and an imported ELISA kit (Vironostika HIV Uni - Form II plus O). Methods: Two hundred serum samples were used to test five domestic ELISA kits and 100 of them were used to test the imported kit (Vironostika HIV Uni - Form II plus O). Results: Six ELISA kits had sensitivities from 90. 14% to 100%, test powers from 96. 5% to 100% and NPV values from 94.85% to 100% ; four kits had specificities of 100% and positive predictive values (PPV) of 100% , and gave no false positive results; two kits had specificities of 97.67%, with false positive reactions of 2.33% and positive predictive values of 95.89% and 95.71% respectively; with the exception of Vironostika, five domestic kits presented some positive missing rates with 9. 86%, 4.23%, 1.41%, 7.04% and 5.63% respectively. Conclusion: The quality evaluation of six ELISA kits indicated that Vironostika ranked the first place, and B ranked the second, followed by other four in order. The present article suggests that: (1) The positive missing rates in domestic ELISA kits must be eliminated as soon as possible, so that their quality may be improved. (2) The quality evaluation of HIV" Ab ELISA Kits should become a regular practice. (3) In detection practice, suitable ELISA Kits should be used according to different epidemic situations and different monitoring purposes.