Lyon H
Department of Pathology 134, Hvidovre Hospital, University of Copenhagen, Denmark.
Biotech Histochem. 2000 Jul;75(4):176-82. doi: 10.3109/10520290009066498.
The purpose of biological staining is to obtain specimens of biological material that can be assessed in the microscope. These specimens are influenced by all processes from removal from the intact organism to mounting on the microscopic slide. To achieve comparable results with various techniques for biological staining, standardization of all procedures and reagents is mandatory. In this paper, I focus particularly on dyes and consider the possibilities for obtaining standardized dyes. In general practice, most biological staining takes place with available commercial dyes. These dyes may or may not have been subjected to quality assessment either internally by the producer or vendor or externally by independent investigators or organizations such as the Biological Stain Commission. Concerted attempts at standardization in Europe are discussed. The latest results of this work, the European standard EN 12376, is presented. This standard is concerned with information supplied by the manufacturer with in vitro diagnostic reagents for biological staining. The standard has been prepared by a Working Group on Staining in Biology under Technical Committee 140, In Vitro Medical Devices, of the European committee for standardization, CEN.
生物染色的目的是获得能够在显微镜下进行评估的生物材料标本。这些标本受到从完整生物体中取出到安装在显微镜载玻片上的所有过程的影响。为了通过各种生物染色技术获得可比的结果，所有程序和试剂的标准化是必不可少的。在本文中，我特别关注染料，并考虑获得标准化染料的可能性。在一般实践中，大多数生物染色使用现有的商业染料进行。这些染料可能已经或可能尚未经过生产商或供应商的内部质量评估，也可能未经过独立研究人员或组织（如生物染色委员会）的外部质量评估。本文讨论了欧洲在标准化方面的协同努力。介绍了这项工作的最新成果——欧洲标准EN 12376。该标准涉及制造商提供的用于生物染色的体外诊断试剂的信息。该标准由欧洲标准化委员会CEN技术委员会140（体外医疗器械）下属的生物染色工作组制定。
