生物样本库能力验证发展状况  

Development status of proficiency testing for biobanks

作　　者：张小燕[1] 王岩 孟露露 孟影 徐燕萍 贾汝静[3] 郜恒骏[1] ZHANG Xiaoyan;WANG Yan;MENG Lulu;MENG Ying;XU Yanping;JIA Rujing;GAO Hengjun

机构地区：[1]生物芯片上海国家工程研究中心,上海201203 [2]上海芯超生物科技有限公司,201203 [3]中国合格评定国家认可中心,北京100062

出　　处：《中国医药生物技术》2025年第S1期50-54,62,共6页Chinese Medicinal Biotechnology

摘　　要：生物样本库作为现代医学研究的基石,对临床研究、药物开发、疾病诊断和治疗具有不可替代的作用。随着精准医疗和个性化治疗的兴起,生物样本库的重要性愈发凸显。本文回顾了2017–2024年间中国生物样本库能力验证的发展状况。研究结果表明,参与能力验证的生物样本库数量逐年增加,样品种类和复杂度逐步提高,满意率逐年提升,反映出生物样本库质量控制水平的持续改进。总体而言,生物样本库能力验证在中国的发展取得了显著成效,为提高生物样本库的质量和可靠性提供了有力支持。未来,随着技术的不断进步和标准的不断完善,能力验证将在生物样本库的质量管理中发挥更加重要的作用。Biobanks,as the cornerstone of modern medical research,play an irreplaceable role in clinical research,pharmaceutical development and disease diagnosis&treatment.With the rise of precision medicine and personalized therapies,the importance of biobanks has become increasingly evident.This article reviews the development of proficiency testing for biobanks in China from 2017 to 2024.The research results indicate that the number of biobanks participating in proficiency testing has increased annually with the variety and complexity of samples gradually improving and satisfaction rates rising year by year,which reflects the continuous improvement in the quality control level of biobanks.Overall,significant progress has been made in the development of proficiency testing for biobanks in China,providing powerful support for improving the quality and reliability of biobanks.In the future,proficiency testing will play a much more critical role in the quality management of biobankswith ongoing technological advancements and the continuous improvement of standards.

关 键 词：生物样本库 能力验证 质量控制 标准化 

分 类 号：R318[医药卫生—生物医学工程]