雅培c16000全自动生化分析仪上的试剂交叉携带污染发现及解决方案  

Detection and Solution of Reagent Carryover Contamination in the Automatic Biochemistry Analyzer

作　　者：张小轶[1] 孙芙蓉 邹本辉 扈锡涛 蒋琳[2] 杜晓艳 王存新[1] ZHANG Xiaoyi;SUN Furong;ZOU Benhui;HU Xitao;JIANG Lin;DU Xiaoyan;WANG Cunxin(College of Life Science and Bioengineering,Beijing University of Technology,Beijing 100124,China;BIOSINO Bio-Technology & Science INC,Beijing 100124,China)

机构地区：[1]北京工业大学生命科学与生物工程学院,北京100124 [2]中生北控生物科技股份有限公司,北京102200

出　　处：《北京工业大学学报》2018年第1期144-150,共7页Journal of Beijing University of Technology

基　　金：北京市教育委员会科研计划面上项目(km201410005030);北京市教育委员会北京市属高校青年拔尖人才项目(Xiaoyi Zhang);北京高等学校高水平人才交叉培养"实培计划"毕业设计项目(Xiaoyi Zhang);国家自然科学基金资助项目(31100523);国家"863"计划资助项目(2014AA022301);北京市科技计划G20工程龙头企业培育资助项目(Z161100001816043)

摘　　要：为了解决临床生化检测中隐蔽的交叉携带污染,提出了一种合理普适的交叉携带污染评估和解决方案.该方案采用雅培c16000全自动生化分析仪,设计合理普适的交叉携带污染测定试验及特殊的污染清洗程序,对体外诊断市场中占有率较高的中生试剂的交叉携带污染情况进行评价,通过对31个临床常规检测试剂盒的930个组合进行交叉携带污染试验,对隐蔽性的交叉携带污染提出判定标准,并对具有交叉携带污染的组合用提出的特殊的清洗程序进行清洗.结果表明,传统标准仅识别出10个具有交叉携带污染的组合,而提出的新标准比传统标准额外识别出了5个交叉携带污染组合.对以上15组具有交叉携带污染的组合用提出的特殊的清洗程序进行清洗,其污染率绝对值全部显著降低,且交叉携带污染情况全部得到消除.In order to solve the concealment carryover contamination in clinical chemistry assay,a versatile judgment standard and a solution for reagent carryover contamination were designed.The reagent carryover contamination of930combinations between31types in-vitro diagnostic kits of BioSino were evaluated by using automatic biochemical analyzer(Abbott c16000),and a new judgment standard was put forward which is conducive to finding out those concealed carryover contaminations.Then a special cleaning procedure was designed.Results showed that10combinations with carryover contamination were identified by using traditional standard,and5more combinations with carryover contamination were picked out by using the new standard.The special cleaning procedure was used to the15combinations,in which the contamination rates of the15combinations were all significantly reduced and carryover contaminations of them were all eliminated.

关 键 词：全自动生化分析仪 体外诊断试剂盒 交叉携带污染 清洗程序 

分 类 号：R446[医药卫生—诊断学]