丙型肝炎病毒抗体酶标诊断试剂及国家质控参考品的关系

Relationship between Hepatitis C virus(HCV) Antibody Enzyme-Linked Immunosorbent Diagnostic Reagents and National Quality Control Reference

目的对丙型肝炎病毒(HCV)抗体酶联免疫诊断试剂和抗HCV国家质控参考品的过去﹑现在和未来进行回顾和展望。方法根据HCV抗体酶联免疫诊断试剂和抗HCV国家质控参考品的研制过程,对国产和进口抗-HCV酶联试剂的检测灵敏度、特异性进行论述,阐明国家质控参考品所起到的作用。结果与结论目前我国的丙型肝炎病毒抗体酶标诊断试剂已接近或达到国际发达国家同类产品的质量水平。与之相伴的HCV抗体国家质控参考品也随之不断完善,对抗HCV酶联免疫诊断试剂的质量控制起到了重要的作用。

Objective To rewiew the hepatitis C virus （HCV） antibody enzyme-linked immunosorbent diagnostic reagents and national anti-HCV quality control reference. Methods According to the development process of HCV antibody enzyme-linked immunosorbent diagnostic reagents and national anti- HCV quality control reference, we discuss the sensitivity, specificity of Anti-HCV enzyme-linked reagents for imports and domestic, and clarify the important role of the national quality control reference in quality control. Results and Conclusion The Anti-HCV ELISA kits have approached or reached the quality level of the developed countries＇ similar products. National anti-HCV quality control reference becomes perfect and provides important support for quality control of HCV antibody enzyme-linked immunosorbent diagnostic reagents.