甲型流感病毒H1N1型灭活病毒标准物质研究OACSTPCD
Research of a Reference Material of Inactivated Influenza A(H1N1)Virus
以人工培养真实病毒为原料,研制了一种甲型流感病毒H1N1型灭活病毒标准物质.该标准物质经化学灭活及灭活效果验证后,联合多家实验室采用数字PCR定量检测方法对拷贝数浓度进行定值,对标准物质的均匀性、稳定性及不确定度进行了评估.结果显示该标准物质均匀性良好,在-80～-70℃保存条件下稳定保存5个月,标准物质最终定值结果为(1 384.5±249.3)copies/μL(k=2).该标准物质可为H1N1型甲型流感病毒检测的全过程提供计量溯源和质量控制支撑,有助于提升相关核酸检测结果的准确性和可靠性.
A reference material(RM)of inactivated influenza A(H1N1)virus was developed.The RM was made of artificially cultured natural virus as raw materials.After chemical inactivation and verification of the inactivation effect,the copy number concentration was determined by digital PCR(dPCR)in different laboratories.The homogeneity,stability and uncertainty of the RM were evaluated in detail.As the results demonstrated,the RM can be stably stored for more than 5 months under-80～-70 ℃.The final certified value of reference materials was(1 384.5±249.3)copies/μL(k=2).The RM can be used for the metrological traceability and quality control in the whole process of influenza A virus H1N1 detection and help to improve the accuracy and reliability of related nucleic acid test results.
许丽;乐丽欢;杨雪;王炤坤;李兰英;闻艳丽;陶晴;胡轶红;刘刚
上海市计量测试技术研究院国家市场监管重点实验室(生物分析计量溯源),上海 201203中国科学院上海免疫与感染研究所公共技术服务中心病原发现与大数据平台,上海 200031
生物计量学甲型流感病毒H1N1灭活病毒标准物质数字PCR
biometrologyinfluenza A virus,H1N1,inactivated virus,reference material,digital PCR
《计量学报》 2024 (002)
294-299 / 6
国家自然科学基金(22074093);国家市场监督管理总局技术保障专项(2022YJ10)
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