某全自动血细胞分析仪的方法学性能评价

Methodology performance evaluation of an automated hematology analyzer

目的探讨BC-5390CRP全自动血细胞分析仪的方法学性能。方法根据国家卫生行业标准(WS/T406-2012)和美国临床实验室标准化委员会(NCCLS)EP系列文件检测白细胞、红细胞、血红蛋白和血小板等指标,进行本底计数、携带污染、精密度、线性范围、正确度、不同模式间比较和白细胞分类等性能验证及评价。结果与行业标准规定的分析质量要求相比较。结果BC-5390CRP全自动血细胞分析仪的本底计数、携带污染、精密度、线性范围、正确度、不同模式间偏差均在行业标准质量要求的范围内。结论BC-5390CRP全自动血细胞分析仪的方法学性能可靠,符合临床需求。

Objective To evaluate the performance of the Mindray BC-5390CRP automated hematology analyzer.Methods According to the national health industry standard WS/T406-2012 and EP series documents of NCCLS,the indicators,including white blood cell,red blood cell,hemoglobin and platelet and so on,were detected.The performance verification and evaluation of background count,carryover pollution rate,precision,linearity range,trueness,comparison among different patterns and leukocyte differential count were performed.The evaluation results were compared with the analysis quality requirements regulated by the industrial standards.Results The background count,carryover pollution rate,precision,linearity range,trueness and bias among different patterns of the Mindray BC-5390CRP automated hematology analyzer all were within the scope of industry standard quality requirements.Conclusion The methodological performance of the Mindray BC-5390CRP automated hematology analyzer is reliable and meets the requirements of clinical tests.