生物样本库的规范化管理和标准化操作

Standardized management and operation of biobank

生物样本库为各类科学研究提供高质量的生物样本,同时在精准医学研究中扮演了重要的角色。近年来,我国生物样本库事业也在快速发展。本文通过总结国内外样本库的监管机制、认证(认可)与标准、伦理及标准化操作,希望为国内生物样本库的标准化建设提供参考。

Biobank provides high-quality biospecimens for science research,playing an important role in precision medicine.Foreign organizations established various types of biobanks firstly,while Chinese biobanks are developing rapidly in recent years.This review summarized the supervision mechanism,certification(assurance) and standardization,ethical and standard operating procedure(SOP) of biobank world widely,in order to offer references for the standardization of biobank of our country.