日立7020全自动生化分析仪野外医疗条件下的性能验证  

Performance evaluation of the HITACHI 7020 automatic biochemistry analyzer in field condition

作　　者：徐忠玉[1] 陈彬[1] 许永志[1] 谢志雄[1] 

机构地区：[1]解放军第一七五医院厦门大学附属东南医院检验科,福建漳州363000

出　　处：《中国卫生检验杂志》2016年第17期2516-2518,共3页Chinese Journal of Health Laboratory Technology

摘　　要：目的评价日立7020全自动生化分析仪在野外医疗条件下的性能。方法通过11种应急检验项目,评价日立7020全自动生化分析仪模拟野外医疗前后分别进行精密度、正确度、高低值携带污染率等方面的性能。结果日立7020全自动生化分析仪在野外医疗条件下前后批内精密度分别为0.28%～2.77%和0.35%～2.81%;日间精密度分别为0.57%～3.53%和0.95%～3.90%;与靶仪器比对平均偏倚为1.90%～5.46%;留样再测结果平均偏倚为1.28%～3.82%;高低值携带污染率均〈0.5%,所有性能满足ISO 15189实验室质量体系要求。结论日立7020全自动生化分析仪体积小、自动化程度高,且在野外医疗条件下,各方面性能稳定良好,可平战结合,满足现代方舱医院建设和发展的需求。Objective To evaluate the performance of the HITACHI 7020 automatic biochemistry analyzer in the field condition. Methods The flied environment was simulated to evaluate the precision,accuracy,linearity,carryover of 11 emergency testes with the HITACHI 7020 automatic biochemistry analyzer. Results The within-run precision was within 0. 28%-2. 77% and 0. 35%-2. 81%. The between-day precision was within 0. 57%-3. 53% and 0. 95%-3. 90%. The mean bias of the comparison to the target instrument were within 1. 90%-5. 46%. The mean bias of retest were within 1. 28%-3. 82%and the carryover rate between high and low value of samples was less than 0. 5%,and all the performances met the requirements of ISO 15189 laboratory quality system. Conclusion The HITACHI 7020 automatic biochemistry analyzer possesses a small volume and highly automated method no mater in peacetime or in wartime. It can meet the needs and the development of modern field hospital construction.

关 键 词：日立7020全自动生化分析仪 性能验证 野外医疗卫生装备 平战结合 

分 类 号：TH789[机械工程—仪器科学与技术]