AutolumiS系列全自动化学发光测定仪的研究与设计  

Research on the design of automatic chemiluminescence immunoassay(CLIA) system

作　　者：冯念伦[1] 孙仲轩 苏本华[1] 杨盛林[3] 刘义庆[1] 贾向阳 

机构地区：[1]山东大学附属省立医院医学工程部,山东济南250021 [2]山东正严实业有限公司,山东济南250014 [3]山东省药品审评认证中心,山东济南250014 [4]威海威高生物科技有限公司,山东威海264209

出　　处：《中国医学装备》2014年第9期30-34,共5页China Medical Equipment

摘　　要：目的:开发国产全自动化学发光测定仪,有效推动我国免疫分析技术的发展。方法:基于直接化学发光机制设计全机,包括光、机、电、软件、液路及温控等控制部分;采用微量生物试样精确加样技术、精密运动控制、闪光检测以及多模块集成控制等技术。结果:AutolumiS系列全自动化学发光测定仪,目前已通过临床试验,并取得了医疗器械注册证。结论:该产品可衍生出全系列的微粒子化学发光诊断试剂产品,以较低的价格,满足临床日益增长的各种疾病的体外诊断的需求。Objective： To promote the development of our immunoassay technology effectively, we designed a domestic automatic chemiluminescence immunoassay（CLIA） system. Methods： We designed the whole machine, based on the direct chemiluminescence mechanism, including light, machine, electricity, liquid, software, liquid, temperature control parts and other control parts. We also used accurate sample technology for the micro biological sample, precision motion control technology, flash detection technology, multi-modules integration controlled technology. Results： We developed the AutolumiS series automatic chemiluminescence immunoassay（CLIA） system successfully. Conclusion： Through clinical trials, the automatic chemiluminescence immunoassay（CLIA） system have gained medical equipment registration certificate. This product can be derived from the whole series of micro particle chemical luminescence diagnostic reagent products; it also can meet the clinical growing diseases in vitro diagnostic needs at a lower price.

关 键 词：化学发光测定仪 直接化学发光 精密运动控制 精确加样 多模块集成控制 闪光检测 

分 类 号：R197.39[医药卫生—卫生事业管理]