国产丙型肝炎病毒NS3抗原的质量检定

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。

Study on quality of China made NS3 antigen

Using anti-HCV antibody screening assay to control the quality for blood is the main measure for preventing transmission of HCV in China. This study is to evaluate the quality of NS3 antigen because of their positive rate to anti NS3 antibody in HCV infected patients and to all kinds of anti -HCV antibody detecting kits, that need NS3 antigen. We collected four China genetically engineered NS3 antigens and other two NS3 antigens came from abroad. The first step is to confirm that the antibody reactivity with coated NS3 antigen is true. The second step is to compare the quality of China made NS3 antigens with NS3 antigens abroad. The results showed that coated NS3 antigen kits have high sensitivity in identifying the positivity of sera from second generation panel, among them that were RIBA-2 indeterminate or negative. Some negative or fasle positive results by coated Chinese NS3 antigens indicate that manufacturer should make more efforts to ensure the best condition terms for using these antigens.