Beckman Coulter AU5821全自动生化分析仪性能评价  

Evaluation on the performance of the Beckman Coulter AU5821 automatic biochemistry analyzer

作　　者：陶亚[1] 廖经忠[1] 孙谦[1] 吴琼[1] 李民[1] 易斌[1] 

机构地区：[1]中南大学湘雅医院检验科,湖南长沙410008

出　　处：《中国现代医学杂志》2014年第29期91-97,共7页China Journal of Modern Medicine

摘　　要：目的对Beckman Coulter AU5821全自动生化分析仪进行性能评价,验证其性能是否满足临床要求。方法根据ISO 15189要求,参照美国临床实验室标准化委员会（CLSI）的仪器性能验证指南及CLIA＇88法案评价标准,对该检测系统20个常规生化检验项目的正确度、精密度、线性范围、参考区间、分析灵敏度、抗溶血干扰能力等方面指标进行性能评价。结果 AU5821全自动生化仪平均偏倚在0.49%-4.22%范围内,均小于1/4 CLIA＇88能力验证分析质量要求;批内精密度在0.64%-4.63%范围之内,均小于1/4 CLIA＇88能力验证分析质量要求,日间精密度在0.56%-3.05%范围之内,均小于1/3CLIA＇88能力验证分析质量要求。各检测项目在线性范围内的相关系数r均≥0.999 2,b在0.98-1.01范围内。各检测项目引用的参考区间合适。各项目分析灵敏度远小于参考值下限。血红蛋白浓度小于或等于5 g/L时,对钾、乳酸脱氢酶、总胆固醇、磷、谷草转氨酶、白蛋白、镁检测结果均有不同程度的影响,对其他常规项目影响不大。结论 Beckman coulter AU5821生化分析仪在正确度、精密度、线性范围、参考区间4个方面性能验证合格,同时分析灵敏度高及抗溶血干扰能力基本能满足实验室需求。【Objectives】To assess the analytical performance of Beckman Coulter AU5821 and to identify whether the performance is acceptable for the goals of laboratory performance. 【Methods】 Accuracy, precision,linearity, reference range, analytical sensitivity and hemolytic interference studies were performed on 20 routine clinical chemistry tests based on the Clinical and Laboratory Standards Institute（CLSI） and Clinical Laboratory Improvement Amendment 88（CLIA＇88）. 【Results】 The average bias of each items in the accuracy evaluation experiments were comprised between 0.49% and 4.22% and were under 1/4 CLIA＇88; within-run precision of each items was comprised between 0.64% and 4.63%, the inter-day precision was comprised between 0.56%and 3.05%. Each of them was lower than that of the quarter of CLIA＇88 and one-third of CLIA＇88 respectively. The linearity of each items was also good in the linear range（r ≥0.999 2, b： 0.98 - 1.01）. The reference range of each items cited in our laboratory were satisfied. The analytical sensitivity of each items was far less than the low limit of reference. When Hemoglobin concentration was less than or equal to 5 g/L, it had different degrees of influence on test results, like K, LDH, TC, IP, AST, ALB, Mg. while little influence on other items. 【Conclusion】 The main performance of accuracy, precision, linearity, reference interval of Beckman coulter AU5821 automatic biochemical analyzer was eligible. Meanwhile the analytical sensitivity andthe ability to fight against the interference of hemolysis satisfy the needs of the laboratory performance.

关 键 词：AU5821全自动生化分析仪 性能评价 

分 类 号：R-331[医药卫生]