不同血细胞分析仪白细胞测定结果的比对和偏倚评估

Comparison and error evaluation of white blood cell test result by different hematology analyzers

目的探讨不同的血细胞分析仪间白细胞测定结果的可比性,为本实验室不同血细胞分析仪白细胞检验结果的一致性提供依据。方法以Beckman HMX血细胞分析仪为比较方法,以迈瑞BC-5500血细胞分析仪为实验方法,分别对20份血常规标本进行全血细胞计数,计算实验方法与比较方法之间白细胞计数值的相对偏倚(SE%),并以美国国会1988年通过的临床实验室修正案(CLIA’88)中推荐允许误差为判断标准,判断不同血细胞分析仪白细胞测定结果的一致性。结果两种血细胞分析仪白细胞检测项目的批内精密度低于厂商声明和本实验室规定的精密度要求,比对实验数据可靠。迈瑞BC-5500血细胞分析仪WBC的SE%均≤1/2CLIA’88允许误差范围(7.5%),结果可接受,两种血细胞分析仪WBC测定结果一致。结论两台血细胞分析仪重复性较好,相关性良好,结果具有可比性,在临床中可同时或交替使用。在今后的工作中应注意,同一实验室如果有两台以上相同的设备时,应进行比对和偏倚评估,判断其一致性,以保证同一实验室测定结果的可比性,为临床提供稳定可靠的实验数据。

Objective To discuss the comparability of the results of WBC determination between different hematology ana- lyzers. Methods Beckman HMX hematology analyzers were used as the method of comparison, complete blood cell count to the 20 routine blood marks was conducted, the relative bias of white blood cell count was calculated between experiment method and comparative method, and error range was taken the recommended by Clinical Laboratory Improvement Amend- ments（ CLIA＇ 88）, which was approved by United States Congress in 1988, as the criterion, in order to judge the consis- tency of the results of different hematology analyzers. Results The degree of precision between two types of hematology analyzers was lower than the statement of manufacturer as well as the requirement of the laboratory, which was more reliable than the research data. The SE% of Mairui BC -5500 hematology analyzers WBC was less than or equal to the permitted error range （7.5%） of 1/2CLIA＇88. The result was acceptable and the rest results of the two hematology analyzers were consistent. Conclusion The repeatability and correlation of the two hematology analyzers turn out to be well. The results are comparable, which can be used spontaneously or interchangeably in clinical trials. It is worth to be aware that comparison and deflection evaluation are necessary when there are more than two same equipments in laboratory to judge the consistency, guarantee the comparability of the laboratory test results and provide clinic with reliable research data.