Beckman Coulter Unicel DxH800血细胞分析系统性能验证评价  

Performance evaluation of Beckman Coulter DxH800 hematology analyzer

作　　者：杨洪乐[1] 杨丽妙[1] 汪冉[1] 刘学广[1] 杜欢欢[1] 宋建强[1] 

机构地区：[1]河北医科大学第二医院检验科,河北石家庄050000

出　　处：《河北医科大学学报》2017年第6期699-704,共6页Journal of Hebei Medical University

摘　　要：目的验证和评价Beckman Coulter DxH800血细胞分析系统的主要性能指标。方法参考行业标准WS/T 406-2012临床血液学检验常规项目分析质量要求和仪器说明书,对Beckman Coulter DxH800血细胞分析系统的本底计数、携带污染率、精密度、线性范围、可报告范围、正确度、实验室内的结果可比性、准确度等性能指标进行评价。结果 Beckman Coulter DxH800血细胞分析系统的本底测试、携带污染率、批内精密度和日间精密度均可以满足仪器说明书和WS/T 406-2012文件要求;线性验证白细胞、红细胞、血红蛋白和血小板均满足a值在1±0.05范围内、相关系数(r)≥0.975的要求;覆盖医学决定水平范围临床标本的检测结果与稀释倍数呈良好的线性关系(r>0.990),实测可报告范围大于仪器的可报告范围,完全能满足临床需要;正确度验证标本检测均值与定值的偏倚满足要求;Beckman Coulter DxH800血细胞分析系统与Beckman Coulter LH750血细胞分析系统的仪器间比对具有良好的相关性;准确度验证中项目的相对偏差均明显低于要求值,符合要求。结论Beckman Coulter DxH800血细胞分析系统性能指标均表现良好,符合分析质量要求,能较好地满足临床工作。Objective To verify and evaluate the main performance system of Beckman Coulter DxH800 Hematology Analyzer.Methods Refer to industry standard of WS/T 406-2012 analytical quality specifications for routine tests in clinical hematology and Instrument specification,the background count,carryover rate,precision,linearity range,reportable range,accuracy,comparability of results in laboratory,degree of preciseness of Beckman Coulter DxH800 hematology analyzer were verified.Results The background count,carryover rate,inter-batch precision and inter day precision of Beckman Coulter DxH800 Hematology Analyzer can all satisfy the requirements of Instrument specification and WS/T 406-2012.Linear verification of white blood cell,red blood cell,hemoglobin and platelet can all satisfy the requirements of a value in the 1±0.05 range and the correlation coefficient （r）〉0.975.The results of clinical specimens which covered the medical decision level range had a good linear relationship with the dilution ratio（r〉0.990）.That the reported range of measurement was larger than that of the instrument,which can meet the clinical needs.The bias of the mean and the constant value of samples of the accuracy verification can content the requirements.It had a good correlation between Beckman Coulter DxH800 and Beckman Coulter LH750 Hematology Analyzer.The relative deviations of the items in the accuracy verification which accorded the requirements were obviously lower than the required values.Conclusion The performance indexes of Beckman Coulter DxH800 Hematology Analyzer showed excellent performance,and it could meet the requirement of the analysis quality,and could meet the clinical work well.

关 键 词：血细胞 医学检验学 评价研究 

分 类 号：R331.12[医药卫生—人体生理学]