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

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.