生化自动分析仪在我国临床应用规范化和国产化的历史、现状和发展趋势

Regularization of Automatic Biochemical Analyzer in Clinical Application and Its Domestic State

本文提出从1972年第一台生化自动分析仪引进应用到临床至今,生化自动分析仪临床应用的发展可划分为四个阶段:临床应用的初级阶段;生化分析仪被广泛认识和接受;迅速发展时期;临床应用向可靠,高效和现代化发展,这期间发布了《自动生化分析仪临床应用规范》,加强了生化分析的室内质控和室间质评,促进了实验室检测准确性和室间可比性。文中具体介绍了生化分析仪临床应用规范化的主要内容;生化自动分析仪国产化的进展,典型仪器的性能,对国产化过程中的经验教训做了初步讨论。

The first automatic biochemical analyzer appeared in 1972. From it was applied to the clinical applications to nowdays, the development of clinical auto-analyzer can be divided into four stages： the initial stage of clinical application; biochemical analyzer was widely recognized and accepted; rapid period of development; clinical applications to reliable, efficient and modern development. During four stages, the ＂clinical application of automatic biochemical analyzer regulations ＂ was publiced. It strengthened the biochemical analysis of the internal quality control and external quality assessment, and promoted accuracy and comparability between rooms. This paper specifically describes the main content of standardization for clinical application of biochemical auto-analyzer,its localization progress , the typical performance of the instrument, and makes a preliminary discussion on the lessons of localization.