人类免疫缺陷病毒抗体酶联免疫诊断试剂的质量评价

Quality evaluation of anti-HIV antibody ELISA kits collected from market

目的 评价市场流通中 HIV抗体酶联免疫诊断试剂的质量。方法 从使用单位抽取 2 0家试剂 ,用国家参考品、确证为阳性的样品和阴性样品对其进行检测和分析。结果 2 0家试剂均符合 2 0 0 1 0 7批国家参考品的质量要求 ,对 76份确证为阳性样品的检出率为 1 0 0 .0 % ,1 6家试剂对 88份阴性样品的检出率为 1 0 0 .0 % ,3家试剂为 98.9% ,1家试剂为97.7%。结论 我国 HIV抗体诊断试剂的灵敏度较高 ,但某些试剂的特异性仍需提高。

Objective To investigate the quality of anti-HIV antibody ELISA kits collected from market. Methods Anti-HIV antibody ELISA kits produced by 20 manufactures were collected from market and evaluated by using nationalreference panel, 76 confirmed positive samples and 88 negative samples for HIV antibody.Results All the kits collected from market met with the requirement of national reference panel. The sensitivity for all kits was 100.0% while detecting 76 confirmed positive samples and specificity was 100.0% for 16 kits,98.8% for 3 kits and 97.7% for 1 kit while detecting 88 negative samples for anti-HIV antibody.Conclusion The sensitivity of anti-HIV antibody ELISA kit is high and specificity is needed to be improved.