迈瑞BS-820全自动生化仪性能评价  

Performance evaluation of Mindray BS-820 automatic biochemical analyzer

作　　者：张雯佳[1] 张静静[1] 邓桂花[1] 梁少聪 袁小澎[1] 

机构地区：[1]南方医科大学珠江医院检验医学部,广州510000

出　　处：《重庆医学》2016年第10期1326-1329,1333,共5页Chongqing medicine

基　　金：国家科技支撑计划课题(2013BAI17B04)

摘　　要：目的对广州地区基层医院正在使用的迈瑞BS-820全自动生化仪进行性能评价,验证其性能是否满足临床需要。方法根据美国临床和实验室标准化协会（CLSI）推荐的EP5-A2、EP6-A、EP7-A2、EP-17A文件和《中华人民共和国医药执业标准》YY/T0654-2008文件,采用16个常规生化项目对迈瑞公司BS-820全自动生化仪检测系统的精密度、线性范围、抗干扰能力、灵敏度及携带污染率进行性能评价。结果 BS-820系统所进行的评价分析结果显示,所有项目的精密度实验结果均为合格。15个生化项目在测试范围内都表现出良好的线性关系,相关系数r≥0.997 9。16个生化项目中,总胆红素（TBIL）、总蛋白（TP）、总胆固醇（TC）、三酰甘油（TG）、低密度脂蛋白（LDL）、高密度脂蛋白（HDL）、尿素（UREA）、钙（Ca）8个项目的抗胆红素、TG和血红蛋白干扰能力符合或高于厂家宣称的抗干扰能力,其余的8个项目有1~3种抗干扰能力低于厂家宣称。16个生化项目的空白限（LOB）均小于厂家宣称的LOB。谷氨酸（Glu）的携带污染率为0.02%,低于0.50%。结论该仪器有良好的精密度、灵敏度,携带污染率低,线性范围理想,抗干扰能力基本能满足临床需求。适合中小规模检验科使用。Objective To evaluate the analytical performance of Mindray BS-820 automatic biochemical analysis system used in primary hospitals in Guangzhou area for verifying whether its performance meeting the clinical requirements.Methods According to the EP5-A2,EP6-A,EP7-A2 and EP-17 Afiles recommended by CLSI and the Pharmaceutical Industry Standard of the People′s Republic of China YY/T0654-2008,the precision,linear rang,anti-interference capability,sensitivity and carry-over rate of the Mindray BS-820 automatic biochemical analysis system were evaluated by adopting 16 routine biochemical items.Results The precision results of all 16 analyzing items conducted by the Mindray BS-820 automatic chemical analysis system conformed to the requirements.The results of 15 items showed good linear relation during the testing range（r≥0.997 9）.In 16 biochemical items,the anti-interference capability of TBIL,TP,TC,TG,LDL,HDL,UREA and Ca to bilirubin,triglyceride and hemoglobin conformed to or were higher than the anti-interference capability declared by manufacturer,but among other 8items,the anti-interference capability of 3items was lower than that declared by manufacturer.The limit of blank（LOB）of all 16 analyzing items was less than LOB in the kit instruction.The carry-over rate of Glu was 0.02%,less than 0.50%.Conclusion This instrument has good precision,sensitivity and low carry-over rate（0.02%）,the linear range is ideal,r≥0.997 9,the anti-interference capability basically satisfies the clinical needs.Therefore this instrument is suitable for the use in the middle-small scale laboratory department.

关 键 词：全自动生化分析仪 性能评价 精密度 线性范围 抗干扰能力 灵敏度 携带污染率 

分 类 号：R197.39[医药卫生—卫生事业管理]