丙型肝炎病毒抗体诊断试剂盒专项抽验情况分析及建议  

Analysis and Suggestions on Sampling Test of Anti-HCV EIA Kits

作　　者：于洋[1] 谷金莲[1] 梁争论[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2015年第7期687-693,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:了解丙型肝炎病毒抗体诊断试剂盒(酶联免疫方法)的总体质量状况,为丙型肝炎病毒抗体诊断试剂盒(酶联免疫方法)的质量监测及监督管理提供参考。方法:根据《中国药典》2010年版三部丙型肝炎病毒抗体诊断试剂盒(酶联免疫法)质量标准,对抽取的丙型肝炎病毒抗体诊断试剂盒(酶联免疫方法)进行法定检验;并进行了与同品种进口试剂盒的质量比较等探讨性研究。结果:按《中国药典》2010年版三部标准检验,抽取的96批样品检验结果全部符合规定,从不同厂家、不同环节抽取的样品质量无显著性差异;国产试剂盒和进口试剂盒对不同基因型系列转换血清PHV901(基因型1a)﹑PHV912(2b/3)的检测结果一致。结论:丙型肝炎病毒抗体诊断试剂盒(酶联免疫法)总体质量良好。Objective： To understand the overall quality status of anti-HCV EIA kits, and to provide references for safety monitoring and administration of anti-HCV EIA kits. Methods： According to the quality standard of anti-HCV EIA kits in Chinese Pharmacopoeia（vol. 3, 2010 edition）, the statutory inspection was conducted on the sampled kits, and the exploratory study was conducted to compare the sampled kits with the quality of imported kits of the same variety. Results： All the 96 lots met the requirements of the Chinese Pharmacopoeia（vol. 3, 2010 edition） and there was no signifi cant difference in the quality of the samples from different manufacturers and different sampling links. The testing results of a series of seroconversion with different genotypes PHV901（type 1a） and PHV912（2b/3） were consistent for domestic and imported kits. Conclusion： The overall quality of all the sampled kits is good.

关 键 词：丙型肝炎 病毒感染 病毒抗体 酶联免疫法 抽验 探索性研究 

分 类 号：R939.47[医药卫生—生药学]