The Metal Stable Isotope Geochemistry Laboratory(MSIGL)at the University of Science and Technology of China has developed state-of-the-art analytical methods for twelve stable isotope systems,including Mg,Si,V,Fe,Cu,Z...The Metal Stable Isotope Geochemistry Laboratory(MSIGL)at the University of Science and Technology of China has developed state-of-the-art analytical methods for twelve stable isotope systems,including Mg,Si,V,Fe,Cu,Zn,Rb,Sr,Ag,Cd,Ba,and U.Geological and biological samples were first digested by acid dissolution or alkali dissolution.The target element was subsequently purified by the column chromatography method.A Neptune Plus MC-ICP-MS was used to measure isotope compositions and the isotope bias caused during measurements was calibrated by standard bracketing and/or the double spike method.The analytical procedure was carefully checked to ensure the high precision and accuracy of the data.Here,we summarized the protocol of these established methods and compiled the standard data measured at our lab as well as those reported in literature.This comprehensive dataset can serve as a reliable benchmark for calibration,method validation,and quality assurance in metal stable isotope analyses.展开更多
疫苗临床试验抗体评价用标准物质对提升疫苗临床免疫原性检测结果的准确性和可比性具有重要意义。世界卫生组织(World Health Organization,WHO)和我国发布了多个用于评价疫苗临床抗体应答和传染病病原体感染后抗体水平的标准物质,为疫...疫苗临床试验抗体评价用标准物质对提升疫苗临床免疫原性检测结果的准确性和可比性具有重要意义。世界卫生组织(World Health Organization,WHO)和我国发布了多个用于评价疫苗临床抗体应答和传染病病原体感染后抗体水平的标准物质,为疫苗临床抗体检测和血清流调提供了关键的量值基础。为提升抗体类标准物质研制水平,2022年,WHO发布《WHO抗体类二级标准物质制备手册》等指南文件。《中国药典》三部(2025版)通则“0237国家生物标准物质研制”参考上述WHO抗体手册进行了修订,对包括抗体类标准物质在内的生物标准物质研制的关键点提出了相关要求,强调协作标定的预设标准、统计模型和不确定度,要求关注互换性,以及基于生命周期进行稳定性研究和监测。本文归纳了相关标准物质指南和药典要求,并提出我国人用疫苗临床试验抗体评价用标准物质建立和应用的思考。展开更多
基金the National Science Foundation of China(Nos.42273007 and 42473008)the Distinguished Young Scholars of Anhui,China(No.2408085J021)。
文摘The Metal Stable Isotope Geochemistry Laboratory(MSIGL)at the University of Science and Technology of China has developed state-of-the-art analytical methods for twelve stable isotope systems,including Mg,Si,V,Fe,Cu,Zn,Rb,Sr,Ag,Cd,Ba,and U.Geological and biological samples were first digested by acid dissolution or alkali dissolution.The target element was subsequently purified by the column chromatography method.A Neptune Plus MC-ICP-MS was used to measure isotope compositions and the isotope bias caused during measurements was calibrated by standard bracketing and/or the double spike method.The analytical procedure was carefully checked to ensure the high precision and accuracy of the data.Here,we summarized the protocol of these established methods and compiled the standard data measured at our lab as well as those reported in literature.This comprehensive dataset can serve as a reliable benchmark for calibration,method validation,and quality assurance in metal stable isotope analyses.
文摘疫苗临床试验抗体评价用标准物质对提升疫苗临床免疫原性检测结果的准确性和可比性具有重要意义。世界卫生组织(World Health Organization,WHO)和我国发布了多个用于评价疫苗临床抗体应答和传染病病原体感染后抗体水平的标准物质,为疫苗临床抗体检测和血清流调提供了关键的量值基础。为提升抗体类标准物质研制水平,2022年,WHO发布《WHO抗体类二级标准物质制备手册》等指南文件。《中国药典》三部(2025版)通则“0237国家生物标准物质研制”参考上述WHO抗体手册进行了修订,对包括抗体类标准物质在内的生物标准物质研制的关键点提出了相关要求,强调协作标定的预设标准、统计模型和不确定度,要求关注互换性,以及基于生命周期进行稳定性研究和监测。本文归纳了相关标准物质指南和药典要求,并提出我国人用疫苗临床试验抗体评价用标准物质建立和应用的思考。
