部分肿瘤标志物测量不确定度的两种评定方法比较  

The comparison of two methods with the assessment measurement uncertainty for the assay of tumor markers

作　　者：肖勤[1] 陈特[1] 廖君群[1] 胥飚[1] 夏吉荣[1] 毕小云[1] 

机构地区：[1]重庆医科大学附属第一医院检验科,重庆400016

出　　处：《国际检验医学杂志》2013年第22期2963-2964,共2页International Journal of Laboratory Medicine

基　　金：国家临床重点专科建设项目(财社〔2010〕305号)

摘　　要：目的探索不确定度在肿瘤标志物测定中的应用。方法依据GUM的总体原则,采用A、B类评定方法,分别用2种方法计算部分肿瘤标志物(TPSA、CEA、AFP、CA19-9、CA153、SF、FPSA)的不确定度,并分析这2种测量不确定度的相关性。结果以批内、批间重复性和方法偏倚为分量计算的不确定度评估大小主要取决于卫生部室间质评所确定的方法偏倚,其次为批间变异;而以长期不精密度和校准品不确定度为分量计算的不确定度评估大小则主要取决于长期不精密度的不确定度。2种方法计算的不确定度之间无明显相关性。结论在对部分肿瘤标志物进行不确定度评定过程中,仪器方法偏倚所带来的不确定度以及校准品的不确定度在临床检验工作的确定度研究中具有比较大的贡献,为进一步深入探讨不确定度的评定提供了一定的价值和思路。Objective To explore the validation of the measurement uncertainty in the assay of tumor markers. Methods Ac- cording to the GUM general principles, the uncertainty of partly tumor markers （TPSA, CEA, AFP, CA19 9, CA15 3, SF, FPSA） were calculated in two different ways and the correlation between the results were analysed. Results The uncertainties of the tumor markers and special proteins which evaluated by within-run, between-run and bias of systems were decided mainly by the EQA（bias of system）. The uncertainties assessed by long time CV and calibrator uncertainty were depend on the calibrator uncertainty. There was no statistical correlation between two methods. Conclusion In the evaluation process, the bias and calibrator uncertainty con- tribute much more than other components, which could present some clues for further research.

关 键 词：测量不确定度 方法比较 肿瘤标志物 

分 类 号：R730.4[医药卫生—肿瘤]