摘要
核糖核酸(RNA)标准物质是保证核酸体外诊断数据准确一致的重要实物标准,广泛用于病毒类疾病的检测、仪器校准、试剂盒评价及能力验证等工作中,其目的是保证测量过程和测量结果的准确一致。自1997年,WHO研制出了首个针对核酸扩增技术的丙型肝炎核酸国际标准物质,使全球不同实验室、不同方法检测的结果有了可比性。截至2023年,中国在国家标准物质资源共享平台发布的RNA有证标准物质有近百种,对于RNA标准物质的研究与应用,日益受到世界各国计量机构、相关国际学术组织与企业的重视,尤其是新型冠状病毒疫情暴发后,RNA标准物质成为了生物标准物质的研制热点。随着标准物质研制技术的不断发展,标准物质的量值准确性也有所提升,为测量结果的准确一致提供保障。通过对当前RNA标准物质的制备方法、分装、定值技术、不确定度评定及应用领域进行综述,为RNA标准物质的研制工作以及未来在临床医学、农业生产、动物医学、食品安全等领域的应用提供参考。
RNA reference materials is an important physical standard to ensure the accuracy and consistency of nucleic acid in vitro diagnostic data.It is widely used in the detection of viral diseases.It can also be used in calibration instruments,evaluation kits and proficiency testing,which purpose is to ensure the accuracy and consistency of the measurement process and measurement results.Since 1997,WHO has developed the first hepatitis C nucleic acid international reference material for nucleic acid amplification technology,which makes the results of different laboratories and different methods in the world comparable.By 2023,there are nearly 100 kinds of RNA certified reference materials released by China on the National Sharing Platform for Reference Materials.The research and application of RNA reference materials have been paid more and more attention by metrology institutions,relevant international academic organizations and enterprises all over the world.Especially after the outbreak of the novel coronavirus epidemic,the development of RNA reference materials has become a hot spot in the development of biological reference materials.With the continuous development of the reference materials development technology,the accuracy of the reference materials has also been improved,which provides a guarantee for the accuracy and consistency of the measurement results.The preparation methods,sub-package,fixed value technology,uncertainty evaluation and application fields of RNA reference materials are briefly reviewed,which provides a reference for the development of RNA reference materials and their future applications in various fields.
作者
王丹
赵文江
齐鑫
李欣然
李凯
樊丽
李亮
WANG Dan;ZHAO Wen-jiang;QI Xin;LI Xin-ran;LI Kai;FAN Li;LI Liang(College of Horticulture and Plant Protection,Inner Mongolia Agricultural University,Hohhot 010019;Branch of Animal Husbandry and Veterinary of Heilongjiang Academy of Agricultural Sciences,Qiqihar 161005;Institute of Quality Standardand Testing Technology for Agro-Products,Chinese Academy of Agricultural Sciences,Beijing 100081)
出处
《生物技术通报》
CAS
CSCD
北大核心
2024年第6期105-113,共9页
Biotechnology Bulletin
基金
国家自然科学基金项目(32360788)
中国科学院西部之光人才培养计划
科技创新2030农业生物育种重大专项(2022ZD0402013)
中国农业科学院科技创新工程(CAAS-ASTIP-2023-IQSTAP)
中国农业科学院研究所级工作任务(1610072023101)。
关键词
核糖核酸
标准物质
标准物质定值
稳定性
均匀性
不确定度评定
RNA
reference material
characterization of reference materials
stability
homogeneity
evaluation of uncertainty
