乙型肝炎病毒RNA检测试剂国家参考品的研制  

Development of National Reference Panel for Hepatitis B Virus RNA Detection Reagents

作　　者：郝晓甜 刘艳[1] 李克坚[1] 周诚[1] Hao Xiaotian;Liu Yan;Li Kejian;Zhou Cheng(National Institutes for Food and Drug Control,Beijing 100050,China)

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》2023年第4期396-403,共8页Chinese Pharmaceutical Affairs

基　　金：国家科技重大专项(编号2018ZX10102001)。

摘　　要：目的:研制乙型肝炎病毒(Hepatitis B Virus,HBV)RNA检测试剂国家参考品并制定其质量标准。方法:收集并筛选HBV RNA阳性和阴性血浆样本,制备HBV RNA候选参考品。采用不同企业的试剂进行协作标定,根据协作标定结果确定参考品的组成及制定质量标准,并考察其均匀性和稳定性。结果:HBV RNA检测试剂国家参考品由10份阳性参考品,10份阴性参考品,1份精密度参考品和1份灵敏度参考品组成。其质量标准:阳性参考品符合率为10/10;阴性参考品符合率为10/10;精密度参考品稀释10倍后重复检测10次,要求CV≤5%;最低检测限不高于2.1×10^(3)U·mL^(-1)。该参考品均匀性符合要求,室温(25℃)放置3 d、反复冻融3次均未影响参考品的稳定性。结论:研制了首批HBV RNA检测试剂国家参考品并制定了质量标准,为相关试剂的质量控制和评价提供依据。Objective:To develop the national reference panel for hepatitis B virus(HBV)RNA detection reagents and establish its quality standard.Methods:HBV RNA positive and negative plasma samples were collected and screened to develop HBV RNA candidate reference materials.Collaborative calibration was carried out with the reagents from various manufacturers.According to the results of collaborative calibration,the composition and quality standard of reference materials were determined.Meanwhile,the homogeneity and stability of the national reference panel were well studied.Results:The national reference panel for HBV RNA detection reagents consists of 10 positive samples,10 negative samples,1 precision sample and 1 sensitivity sample.Its quality standard was as follows:the coincidence rate of positive samples was 10/10;the coincidence rate of negative samples was 10/10;the precision sample needs to be diluted 10 times and then be tested 10 times,and CV≤5%is required;the minimum detection limit is not higher than 2.1×10^(3)U·mL^(-1).The homogeneity of the reference met the requirements,and the stability of the reference was not aff ected after being placed at room temperature(25℃)for 3 d and repeated freezing and thawing three times.Conclusion:The first batch of national reference panel for HBV RNA detection reagents has been developed,and the related quality standard has been established,which provides a basis for quality control and evaluation of related reagents.

关 键 词：乙型肝炎病毒RNA 检测试剂 参考品 质量标准 

分 类 号：R917[医药卫生—药物分析学]