政策法规

WHO对抗体检测用二级标准品制备的要求和建议

  • 周振歆 ,
  • 赵冰心 ,
  • 王佑春
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  • 1中国医学科学院医学生物学研究所北京协和医学院质量管理处,昆明 650118;2中国医学科学院医学生物学研究所北京协和医学院质量保证部,昆明 650118;3中国医学科学院医学生物学研究所北京协和医学院,昆明 650118

网络出版日期: 2025-08-16

基金资助

中国医学科学院医学与健康科技创新工程“医学健康领军科技人才养募专项”(2022-I2M-3-001)

WHO requirements and recommendations on the preparation of secondary standards for antibody testing

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  • 1Department of Quality Management, Institute of Medical Biology, Peking Union Medical College, Chinese Academy of Medical Sciences, Kunming 650118, China; 2Division of Quality Assurance, Institute of Medical Biology, Peking Union Medical College, Chinese Academy of Medical Sciences, Kunming 650118, China; 3Institute of Medical Biology, Peking Union Medical College, Chinese Academy of Medical Sciences, Kunming 650118, China

Online published: 2025-08-16

Supported by

Project of Science and Technology Innovation in Medical and Health of Chinese Academy of Medical Sciences“Special Project for Recruitment of Scientific and Technological Leading Talents in Medical and Health”(2022-I2M-3-001)

摘要

2023年11月13—16日,WHO在印度尼西亚登巴萨举办了“WHO抗体检测二级标准品制备手册培训”,培训中WHO专家对抗体检测用二级标准品的制备提出了要求和建议。该培训使各国参会代表充分了解了抗体检测用二级标准品研究、使用过程中应注意的问题,加强了各国与WHO的交流,对于我国正在开展的相关工作和加强国际交流具有重大意义。我国应根据WHO对抗体检测用二级标准品制备的要求及建议,进一步做好我国抗体检测用二级标准品的制备工作。

本文引用格式

周振歆 , 赵冰心 , 王佑春 . WHO对抗体检测用二级标准品制备的要求和建议[J]. 国际生物制品学杂志, 2024 , 47(1) : 44 -48 . DOI: 10.3760/cma.j.cn311962-20231214-00024

Abstract

The "WHO Workshop on Implementation of WHO Manual for the Preparation of Reference Materials for Use as Secondary Standards in Antibody Testing" was held in Denpasar, Indonesia, from November 13 to 16, 2023, and the requirements and recommendations on preparing the secondary standards for antibody testing from WHO experts were outlined in this workshop. Representatives from various countries gained a comprehensive understanding of the attentions related to the study and use of the secondary standards for antibody testing, leading to an increasing communication between countries and WHO. This plays a crucial role in advancing related work and promoting international collaboration. China should consider further aligning its preparation of the secondary standards for antibody testing with the relevant requirements and recommendations from WHO.
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