应用全切片图像进行毒性病理学同行评议的研究进展

Research progress in using whole slide images for peer review of toxicologic pathology

全切片图像是通过数字切片扫描仪将整个组织切片扫描生成的二维图像,近年来已广泛应用于病理学教学、组织切片讨论、科研等领域。参照美国毒性病理学会(STP)对全切片图像在诊断中的应用建议、经济合作与发展组织(OECD)和美国食品药品管理局(FDA)关于使用全切片图像进行病理学同行评议的指导原则,对药物非临床研究质量管理规范(GLP)条件下应用全切片图像进行毒性病理学同行评议的工作流程、内容和要求进行相关总结。同时结合中国合同研究组织(CRO)采用全切片图像开展毒性病理学评价进行概述,以期提升我国毒性病理学评价和病理学同行评议工作的规范性与专业水平。

Whole slide images(WSI)are a type of two-dimensional image generated by scanning the entire tissue slides with a digital scanner,which have been widely used in various fields in pathology,including teaching,tissue slide discussion and scientific research in recent years.According to the recommendation of the Society of Toxicologic Pathology(STP)on the application of WSI in diagnosis and the guidance of Organization for Economic Co-operation and Development(OECD)and US Food and Drug Administration(FDA)on WSI use for peer review of toxicologic pathology,this article summarized the procedures,contents,and requirements of WSI peer review under Good Laboratory Practice(GLP)conditions.In addition,it provided an overview of toxicologic pathology evaluation using WSI carried out by contract research organizations(CROs)in China,as an attempt to advance the standardization and professionalism of toxicologic pathology evaluation and pathology peer review in China.