Yumizen H550全自动血液细胞分析仪性能评价  

Performance evaluation of the Yumizen H550 fully automatic hematology analyzer

作　　者：任丹 高琼 REN Dan;GAO Qiong(Clinical Laboratory,TSCM Hospital,Tai’an 271000,China;Horiba(China)Trading Co.,Ltd.,Medical Segment,Shanghai 271000,China)

机构地区：[1]泰安市中医二院检验科,泰安271000 [2]堀场(中国)贸易有限公司医疗事业部,上海271000

出　　处：《实验室检测》2024年第11期146-148,共3页Laboratory Testing

摘　　要：目的对HORIBA ABX Yumizen H550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/T 406—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、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(参照仪器为Sysmex XS800i全自动血液细胞分析仪)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符合行业标准及厂家仪器说明书的要求,白细胞计数(WBC)、红细胞计数(RBC)、血红蛋白(HGB)以及血小板计数(PLT)的携带污染率均通过。批内精密度小于仪器说明书上的要求,远低于行业标准要求。在线性范围内,线性回归方程的斜率在1±0.05范围内,相关系数r>0.975。与Sysmex XS800i的结果比对通过率均大于80%。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均在允许范围内。结论Yumizen H550全自动血液细胞分析仪性能优异,测定结果准确可靠,是一种符合市场需求的全自动血液细胞分析仪。Objective To evaluate the performance of HORIBA ABX Yumizen H550 automatic blood cell analyzer.Methods According to the national health industry standard Quality Requirements for Analysis of Routine Items in Clinical Hematology Examination(WS/T 406-2012),the automatic blood cell analyzer was evaluated for background counting,carrying contamination,in-batch precision,linearity,accuracy,comparability of results in different suction modes,and comparability of results in the laboratory(the reference instrument was Sysmex XS800i automatic blood cell analyzer).Results The detection values of background count of all items of the automatic blood cell analyzer were met the requirements of industry standards and manufacturer’s instrument manuals,and the carryovers of white blood cell(WBC)count,red blood cell(RBC)count,hemoglobin(HGB)and blood platelet(PLT)count of that were all passed.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.Within the linearity range,the slopes of the linear regression equation were within the range of 1±0.05.The correlations coefficient(r)of these equations were larger than 0.975.The pass rate that the results compared with that of Sysmex XS800i were larger than 80%.The compared results of intra clinical laboratory indicated the trueness of instrument,the outcome bias between different suction patterns.Conclusion Yumizen H550 automatic blood cell analyzer has favorable performance,accurate and reliable results.It’s an ideal automatic blood cell analyzer.

关 键 词：全自动血液细胞分析仪 携带污染率 性能评价 

分 类 号：R446.11[医药卫生—诊断学]