血浆检疫期内乙型肝炎病毒污染风险浅析  

Risk Analysis of Hepatitis B Virus Contamination in Plasma during Quarantine Period

作　　者：柯兵兵 王智 程樱 郭江红 姜红 Ke Bingbing;Wang Zhi;Cheng Ying;Guo Jianghong;Jiang Hong(Hubei Institute China;Hubei Engineering Research Center for Drug Quality Control;NMPA Key Laboratory for Quality Control of Blood Products;Yujin Bio-Pharma Wuhan CNBG Co.Ltd)

机构地区：[1]湖北省药品监督检验研究院,武汉430073 [2]湖北省药品质量检测与控制工程技术研究中心 [3]国家药品监督管理局血液制品质量控制重点实验室 [4]武汉中生毓晋生物医药有限责任公司

出　　处：《中国药师》2021年第9期1717-1720,共4页China Pharmacist

摘　　要：近年来,血浆筛查技术不断应用于血液制品原料血浆的病原体筛查,特别是核酸检测技术(NAT),极大地保障了血液制品的安全。本文介绍乙型肝炎病毒(HBV)的病毒学特征、流行病学资料以及相关血清标志物的意义,分析目前血液制品生产过程中血浆筛查模式可能存在的风险,并通过查阅临床研究文献和资料,浅析血浆检疫期内HBV的污染风险,并探讨解决这一风险的可能途径,为血液制品的安全性提供安全建议,为血液制品安全监管工作提供依据。In recent years,plasma screening technology has been applied to the pathogens screening of blood plasma,especially nucleic acid testing(NAT),which greatly guarantees the safety of blood products.In this paper,the HBV virological characteristics,epidemiological data and significance of related serum markers were first introduced,the possible risks of plasma screening in the current production process of blood product were analyzed,and Hepatitis B virus contamination risk in the plasma quarantine period were analyzed by consulting clinical research and literature,and then the possible ways to solve the risks were discussed,so as to provide safety recommendations for the production of blood product,and provide the safety supervision of blood product.

关 键 词：乙型肝炎病毒 隐匿性乙型肝炎病毒感染 酶联免疫吸附试验 核酸检测 

分 类 号：R917[医药卫生—药物分析学]