摘要
目的介绍国内外体外生物诊断试剂参考物质的研究现状与进展。方法通过查阅和分析国内外文献、相关法规,对世界卫生组织和中国体外生物诊断试剂参考物质的管理情况和目前主要的生物诊断试剂参考物质进行总结。结果与结论世界卫生组织可提供多种生物诊断试剂参考物质,但该类参考物质的研究和管理仍需进一步加强和完善。
Objective To introduce the current research status and progress of reference materials of in vitro diagnostic reagents. Methods The reference materials and the management of World Health Organization （WHO） and China were summarized through reviewing domestic and international literatures and related laws and regulations. Results and Conclusion Although WHO can provide various reference materials, it is necessary to further improve the management and study of these reference materials.
出处
《中国药事》
CAS
2013年第3期318-323,共6页
Chinese Pharmaceutical Affairs
基金
国家高技术研究发展计划资助项目(编号2011AA02A115)
关键词
体外生物诊断试剂
参考物质
溯源性
连续性
不确定性
in vitro biological diagnostic reagents
reference material
traceability
continuity
uncertainty
