摘要
目的使用EP9-A3文件评价迈瑞BC-6800和希森美康XN-3000检测结果的一致性。方法分别用BC-6800和XN-3000对40份血液标本进行血常规分析,根据EP9-A3指南绘制散点图、并用适当方法进行回归分析、拟合回归方程,分析两侧血常规分析仪之间测量误差以及在医学决定水平的误差是否在《医学实验室质量和能力认可准则》(CNAS-CL02:2012)可接受标准范围内。结果配对t检验显示两种仪器所测结果存在统计学差异,通过偏倚分析和方法评估后,根据拟合的回归方程,BC-6800和XN-3000所测结果以及各指标在医学决定水平的偏差均位于可接受范围内。结论我实验室所使用的BC-6800和XN-3000所测结果具有可比性、可互认。
Objective To evaluate the consistency of the Mindray BC-6800 and Sysmex XN-3000 using EP9-A3 files.Methods 40 blood samples were randomly collected and tested with BC-6800 and XN-3000 respectively.According to the guidelines of EP9-A3,the scatterplots were drawn and regression analysis was performed with appropriate methods.Then regression equation was fit and the“Analytical quality specifications for routine tests in clinical hematology(WS/T 406-2012)”was as the acceptable standard to analyze whether the measurement error between the BC-6800 and XN-3000 was acceptable.In addition,the level of the medical decision was also analyzed using the fit regression equation to evaluate whether the measurement error of these level of the medical decision between the BC-6800 and XN-3000 was also acceptable.Results The paired t-test showed statistical differences was found between BC-6800 and XN-3000.After the bias analysis and method assessment,the regression equation was fit.The results showed that the measurement deviations between the BC-6800 and XN-3000 and at the medical decision-making level were all within an acceptable range.Conclusion The results of BC-6800 and XN-3000 used in our laboratory are comparable and could be mutually recognized.
作者
魏崴
杨建新
王蕾
WEI Wei;YANG Jianxin;WANG Lei(Department of Laboratory,Shanghai Eighth People′s Hospital,Shanghai,200235,China)
出处
《国际检验医学杂志》
CAS
2018年第A02期12-15,共4页
International Journal of Laboratory Medicine
基金
上海市科委科技攻关项目(17DZ1930301-06)。
