采用“自上而下”和“自下而上”两种方法评定同一检测系统测定六项肿瘤标志物的测量不确定度  

“Top-down” and “bottom-up” methods were used to assess the measurement uncertainty of the same detection system for six tumor markers

作　　者：李晶 张绍军 黄廷荣 徐继勋 LI Jing;ZHANG Shaojun;HUANG Tingrong;XU Jixun(Traditional Chinese Medicine Hospital of Huangshi City,Hubei Province,Huangshi435000,China;Xiaonan District Zhuhu Health Center of Xiaogan City,Hubei Province,Xiaonan432100,China)

机构地区：[1]湖北省黄石市中医医院,湖北黄石43500 [2]湖北省孝感市孝南区朱湖卫生院,湖北孝感432100

出　　处：《中国医药导报》2020年第1期169-173,共5页China Medical Herald

基　　金：湖北省中医药、中西医结合科研项目（鄂卫生计生通[2017]20号-38）

摘　　要：目的通过评定六项肿瘤标志物的测量不确定度,探讨"自上而下"和"自下而上"两种不同不确定度评定方法在临床实验室应用的适用性和差异性。方法依据Nordtest准则评定"自上而下"方法的不确定度,六项肿瘤标志物的室内质控数据作为实验室复现性引入不确定度分量的来源,2015~2018年6次卫生部室间质评回报数据和校准品溯源性数据作为偏移引入不确定度分量的来源,计算合成标准不确定度和相对标准不确定度。采用测量不确定度表示指南(GUM)评定"自下而上"方法的不确定度,引用实验室技术报告,分析实验室七大测量不确定度来源:设备吸光度的重复性,试剂舱温度波动,孵育盘温度波动,加样系统的重复性和准确性,系统携带污染率,环境温、湿度波动,离心机的校准,计算各分量的合成标准不确定度和相对不确定度。结果 "自上而下"的方法评定六项肿瘤标志物(甲胎蛋白、癌胚抗原、糖类抗原125、糖类抗原153、糖类抗原199和总前列腺特异性抗原)的相对合成不确定度分别为:9.0%、7.2%、9.4%、8.3%、11.8%、9.8%;"自下而上"的方法统计结果分别为:8.0%、7.8%、8.1%、9.1%、8.1%、8.4%。两种方法数据比较,差异无统计学意义(P> 0.05)。结论 "自上而下"和"自下而上"的方法均可应用于临床实验室肿瘤标志物测量不确定度的评定。Objective By evaluating the measurement uncertainty of six tumor markers, the applicability and differences of "top-down" and "bottom-up" evaluation methods in clinical laboratory were discussed. Methods Based on the Nordtest guideline for evaluating the uncertainty of the "top-down" approach, the internal quality control data of the six tumor markers were used as the source for introducing the uncertainty component of reproducibility in the laboratory. From 2015 to 2018, the return data of 6 external quality assessment of the ministry of health and the traceability data of calibration products were used as the source of the uncertainty component introduced by deviation, and the uncertainty of synthetic standard and relative standard were calculated. Guide to the expression of uncertainty in measurement(GUM) was used to assess the uncertainty of the "bottom-up" method. Reference laboratory technical reports, laboratory seven big sources of measurement uncertainty: repeatability of absorbance of equipment, temperature fluctuation of reagent chamber, temperature fluctuation of incubation plate, repeatability and accuracy of sampling system, system carrying pollution rate, fluctuation of environmental temperature and humidity, calibration of centrifuge was analyzed,and the synthesis standard uncertainty and relative uncertainty of each component were calculated. Results The relative synthesis uncertainty of the six tumor markers(α-fetoprotein, carcinoembryonic antigen, carbohydrate antigen125, carbohydrate antigen 153, carbohydrate antigen199 and total prostate-specific antigen) was assessed by the "top-down" method as 9.0%, 7.2%, 9.4%, 8.3%,11.8%, and 9.8%, respectively. The results of the "bottom-up" method were 8.0%, 7.8%, 8.1%, 9.1%, 8.1% and 8.4%, respectively. There was no significant difference between the two methods(P > 0.05). Conclusion Both "top-down" and "bottom-up" methods can be applied to the evaluation of uncertainty in the measurement of tumor markers in clinical laboratories.

关 键 词：肿瘤标志物 测量不确定度 测量不确定度表示指南 Nordtest准则 

分 类 号：R446.19[医药卫生—诊断学]