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目的为了研究我国丙型肝炎病毒（ＨＣＶ）诊断试剂用抗原的质量，加快改进丙型肝炎病毒抗体诊断试剂。方法特选国内“八五”攻关课题研究出的丙型肝炎ＮＳ３抗原和目前我国的主要使用的两种国外丙型肝炎ＮＳ３抗原，建立了单片段检测ＮＳ３抗体的试剂，对ＮＳ３抗原质量利用我国抗－ＨＣＶ第二代国家检验参考品以及中国药品生物制品检定所最近收集的部分血清样品，对其抗原性进行了比较研究。结果发现我国生产单位对ＮＳ３抗原的纯化条件及在试剂中的组装条件的研究尚嫌薄弱，使得在利用这些ＮＳ３抗原组成诊断试剂检测时出现了检出率较低及假阳性等问题。结论提示国内有关单位应加强对这方面的研究。
Objective To study the quality of the antigens used in the diagnostic reagents of hepatitis C virus (HCV) in China and to speed up the improvement of diagnostic reagents of hepatitis C virus antibodies. Methods Selected domestic “Eighth Five-Year” research project developed hepatitis C NS3 antigen and currently the main use of two foreign hepatitis C NS3 antigen, established a single detection of NS3 antibody reagents, the quality of NS3 antigen using our country Anti-HCV second-generation national test reference and the China Pharmaceutical and Biological Products Inspection recently collected part of the serum samples were compared antigenicity. The results showed that the purification conditions of NS3 antigen in our production units and the conditions for the assembly in the reagents were still too weak, which led to the problems of low detection rate and false positives when using these NS3 antigen diagnostic reagents. Conclusions suggest that the relevant domestic units should strengthen research in this area.