BC-6800plus型全自动血细胞分析仪性能评价  

Performance evaluation of Mindary BC-6800plus full automatic blood cell analyzer

作　　者：纪玥玥 冯家维 柏玉 黄爱军[1] 沈瀚[1] JI Yue-yue;FENG Jia-wei;BAI Yu(Clinical Laboratory,Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School,Nanjing 210008,China;不详)

机构地区：[1]南京大学医学院附属鼓楼医院检验科,江苏南京210008

出　　处：《中国医学装备》2021年第2期20-24,共5页China Medical Equipment

摘　　要：目的:对迈瑞BC-6800plus型全自动血液细胞分析仪进行性能评价。方法:根据国家卫生行业标准《临床血液学检验常规项目分析质量要求》(WS/T406-2012)对全自动血液细胞分析仪的本底计数、携带污染、批内精密度、日间精密度、线性、正确度、不同吸样模式的结果可比性、实验室内的结果可比性和准确度进行测定评价。结果:全自动血液细胞分析仪的本底计数所有项目检测值均为0,白细胞计数(WBC)、红细胞计数(RBC)、血红蛋白(Hb)以及血小板计数(PLT)的携带污染均<1%。批内精密度和日间精密度均小于仪器说明书上的要求,远低于行业标准要求。仪器的线性范围很宽,线性回归方程的斜率在1±0.05范围内,相关系数r2均>0.95。与BC-6000plus的结果比对通过率为100%。实验室内结果比较仪器的正确度、不同吸样模式下的结果偏差和准确度均在允许范围内。结论:BC-6800plus全自动血液细胞分析仪性能良好,测定结果准确可靠,是一种理想的全自动血液细胞分析仪。Objective:To evaluate the performance of Mindary BC-6800plus full automatic blood cell analyzer.Methods:According to the national health care industry standard<Analytical quality specifications for routine tests in clinical hematology>(WS/T 406-2012),the background count,carryover,within-run precision,inter-day precision,linearity,trueness,comparability of results between different suction patterns,comparability of results of intra clinical laboratory and accuracy of the full automatic blood cell analyzer were determined and evaluated.Results:The detection values of background count of all items of the full automatic blood cell analyzer were 0,and the carryovers of white blood cell(WBC)count,red blood cell(RBC)count,hemoglobin(Hb)and blood platelet(PLT)count of that were less than 1%.The results of within-run precision and inter-day precision were less than the requirements of the specifications of instrument and were far less than the requirements of standard WS/T 406-2012.The linearity was very wide.And the slopes of the linear regression equation were within the range of 1±0.05.The correlations coefficient(r2)of these equations were larger than 0.95.The pass rate that the results compared with that of BC-6000plus was 100%.The compared results of intra clinical laboratory indicated the trueness of instrument,the outcome bias between different suction patterns and accuracy were within the allowed range.Conclusion:BC-6800plus full automatic blood cell analyzer has favorable performance,accurate and reliable results.It’s an ideal full automatic blood cell analyzer.

关 键 词：全自动血液细胞分析仪 准确度 性能评价 

分 类 号：R197.39[医药卫生—卫生事业管理]