DH71CRP全血血细胞分析仪的性能评价  

Performance Evaluation of DH71CRP Hematology Analyzer

作　　者：宿亚菲 孙雯雯[2] 张乐[2] 陈冬哲 王召宝 邢芳琳 王秀芹[2] 刘玲玲[2] SU Yafei;SUN Wenwen;ZHANG Le;CHEN Dongzhe;WANG Zhaobao;XING Fanglin;WANG Xiuqin;LIU Lingling(Grade 2015,Biomedical Engineering Stream of Medical Information Engineering,Jining Medical University,Rizhao Shandong 276826,China;Department of Clinical Laboratory Medicine,Affiliated Shandong Provincial Hospital,Shandong University,Jinan Shandong 250021,China)

机构地区：[1]济宁医学院医学信息工程学院,山东日照276826 [2]山东大学附属省立医院临床医学检验部,山东济南250021

出　　处：《中国医疗设备》2018年第11期55-58,65,共5页China Medical Devices

基　　金：山东省临床重点专科建设项目经费资助项目(鲁卫医字[2013]26号);山东省医药卫生科技发展计划项目(2017WS470)

摘　　要：目的对DH71CRP全血血细胞分析仪检测的性能进行验证和评价。方法参考卫生行业标准WS/T406-2012《临床血液学检验常规项目分析质量要求》,按照NCCLS EP10-A2、EP5-A2、NCCLS EP15-A2、EP6-P2、EP9-A2文件要求,对DH71CRP仪器的精密度、携带污染率、准确度、线性、不同进样模式和仪器白细胞五分类的性能进行评价。结果该仪器的精密度、携带污染率、准确度和线性均在允许范围内。比对结果符合行业标准要求,仪器白细胞五分类的结果与Sysmex XE-2100有很好的符合性和一致性。结论 DH71CRP全血血细胞分析仪血常规检测各方面性能良好,测定结果准确可靠,可以满足医院临床实验室血常规检测的分析要求。Objective To evaluate the performance of DH71CRP hematology analyzer.Methods The precision,contamination rate,accuracy,linearity,different injection patterns and the performance of HBV classification of DH71CRP instrument were evaluated according to NCCLS EP10-A2,EP5-A2,EP15-A2,EP6-A2 and EP9-A2 documentation requirements,and referring to health professional standard WS/T406-2012 Analytical quality specifications for routine tests in clinical hematology.Results The instrument precision,carryover,accuracy,and linear were all within the scope of the permit.Qualification of leukocyte types for morphologic normalities and abnormalities had good conformity with the instrument Sysmex XE-2100,which could well meet the requirements of industry standards.Conclusion The routine blood test of DH71CRP hematocrit analyzer has good performance in all aspects,and the test results are accurate and reliable,which can meet the analysis requirements of routine blood test in the clinical laboratory of the hospital.

关 键 词：血细胞分析仪 性能验证 精密度 准确度 携带污染率 

分 类 号：R446.11[医药卫生—诊断学]