人类免疫缺陷病毒抗体EIA检测试剂质控参考品的建立

以国际抗－HIV质控参考品为参比，用亚塔、阿克苏、UBI、普生、万芬等国内外试剂对41份执－HIV阳性和阴性人血浆进行筛查，并进一步以免疫印迹法确证，建立了我国第一代抗－HIV检测试剂质控参考品，其中包括阳性、阴性、灵敏度和精密性参考品。用本品对91批次国产试剂进行检测并与国外试剂进行对比，证明有较好的分辨力。在此基础上制定出我国抗－HIV检测试剂质量标准，此标准及参考品已获国家批准。

Establishment of Quality Control Reference of EIA Reagent for Anti-HIV Detection

The first quality control references of EIA reagent for anti-HIV detection, including postivity, negativity, sensitivity and precision references, were established by screening 41 samples of anti-HIV positive or negative human plasma by domestic and imported reagents, using International anti-HIV Quallty Control Reference as standard. Confirmatory tests were done by Western Blot. 91 lots of domestic reagents were detected by the reference and compared with imported reagents. The reference showed good resolving capability. Anti-HIV detection reagent quality standard was estabitished on the basis of this study and approved by the National Authority as well as reference,