浙江省入境标准品、质控品及校准品基本现状及利用分析

Basic status and utilization analysis of entry-exit standard products,quality control products and calibrators in Zhejiang province

目的掌握近年来浙江省入境标准品、质控品及校准品的基本情况并提出发展建议。方法通过描述性统计、交叉表卡方、均值比较等方法,对浙江省生物医药特殊物品入境集中监管平台的标准品、质控品及校准品相关信息进行梳理,并分析其基本情况、依赖程度及利用现状。结果浙江省入境的标准品和质控品主要用于生物医药器械企业的科学研究。76.6%的入境标准品、质控品及校准品不可实现国产。入境的标准品和质控品主要原产地为美国,标准品主要原产地为英国。结论浙江省入境的标准品、质控品及校准品,国内目前缺乏生产能力,建议支持国产标准品、质控品及校准品的研发和生产。

Objective Grasp the status of Zhejiang entry standards,controls and calibrators in recent years and problems.Methods Through descriptive statistics,cross-tab chi-square,and comparation of means method,we collected and sorted out relevant information about standard products,quality control products and calibrators of the Zhejiang Provincial Biomedical Special Articles Entry Centralized Supervision Platform,and analyzed the basics of standard products,quality control products and calibrators situation,degree of dependence and utilization.Results The standard products and quality control products imported into Zhejiang province are mainly used for scientific research of biomedical device enterprises.76.6%of imported standard products,quality control products and calibrators cannot be domestically produced.The main origin of imported standard products and quality control products is the United States,and the main origin of standard products is the United Kingdom.Conclusions The standard products,quality control products and calibration products imported into Zhejiang province are currently lacking in domestic production capacity.It is recommended to support the research and development and production of domestic standard products,quality control products and calibration products.