迈瑞BS-820全自动生化仪性能评价
发布时间：2018-07-31 20:16
【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。
[Abstract]:Objective to evaluate the performance of BS-820 automatic biochemical instrument which is being used in primary hospitals in Guangzhou to verify whether its performance meets the clinical needs. Methods according to the EP5-A2 EP5-A2 EP7-A2 EP-17A document recommended by American Association of Clinical and Laboratory Standardization (CLSI) and the YY/T0654-2008 document of the Medical practice Standard of the people's Republic of China, 16 routine biochemical items were used to measure the precision of the BS-820 automatic biochemical instrument test system of Mayre Company. Linear range, anti-interference ability, sensitivity and carrying pollution rate for performance evaluation. Results the results of evaluation and analysis conducted by BS-820 system showed that the precision of all the items was up to standard. All the 15 biochemical items showed a good linear relationship in the range of test, and the correlation coefficient r 鈮，
本文编号：2156710
[Abstract]:Objective to evaluate the performance of BS-820 automatic biochemical instrument which is being used in primary hospitals in Guangzhou to verify whether its performance meets the clinical needs. Methods according to the EP5-A2 EP5-A2 EP7-A2 EP-17A document recommended by American Association of Clinical and Laboratory Standardization (CLSI) and the YY/T0654-2008 document of the Medical practice Standard of the people's Republic of China, 16 routine biochemical items were used to measure the precision of the BS-820 automatic biochemical instrument test system of Mayre Company. Linear range, anti-interference ability, sensitivity and carrying pollution rate for performance evaluation. Results the results of evaluation and analysis conducted by BS-820 system showed that the precision of all the items was up to standard. All the 15 biochemical items showed a good linear relationship in the range of test, and the correlation coefficient r 鈮，
本文编号：2156710
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