迈瑞B S-820全自动生化仪性能评价

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≥0．9979。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。

Performance evaluation of Mindray BS-820 automatic biochemical analyzer

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 Accord‐ing to the EP5‐A2 ,EP6‐A ,EP7‐A2 and EP‐17A files recommended by CLSI and the Pharmaceutical Industry Standard of the Peo‐ple′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 pre‐cision results of all 16 analyzing items conducted by the Mindray BS‐820 automatic chemical analysis system conformed to the re‐quirements .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 8 items ,the anti‐interference capabil‐ity of 3 items 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 .