上海地区肿瘤标志物室间质量评价中允许总误差适宜性的探讨

摘要

目的：分析上海地区肿瘤标志物室间质评的方法变异及实际允许误差范围，并比较与不同国际标准及生物学变异要求提供的允许总误差（TEa）的差异，探讨上海地区肿瘤标志物TEa设置对当前分析质量水平的适宜性。方法以上海市2010至2012年的肿瘤标志物室间质量评价的数据为基础，计算不同方法组在6次室间质评计划中30个样本的合成变异系数（CV），根据合成CV计算上海地区肿瘤标志物室间质评的实际TEa，比较其与德国Rilibak质控指南、澳大利亚皇家病理学会（RCPA）质量要求和生物学变异数据合成的TEa的差异。结果在6次室间质评计划中，血清甲胎蛋白（AFP）、癌胚抗原（CEA）、糖类抗原（CA）125、CA153、CA19-9、前列特异性抗原（PSA）的实际TEa分别为22．63％、22．43％、19．30％、21．56％、27．43％和19．55％，与Rilibak的TEa比较接近，能达到生物学变异数据合成的适合水平的TEa要求，但高于RCPA的TEa范围。结论上海地区的肿瘤标志物室间质评计划的实际TEa水平接近或符合德国Rilibak的要求，略低于比较严格的澳大利亚RCPA的TEa要求，TEa设置方法能够满足当前的质量水平分析。%Objective To analyze the method variation and actual allowable error range for tumor markers in Shanghai External Quality Assessment Scheme,and to compare the difference between international standards and biological variation requirements in order to investigate the suitability of allowable total error (TEa)for tumor markers. Methods Based on the data of Shanghai External Quality Assessment Scheme from 2010 to 2012,30 samples were analyzed to calculate synthetic coefficients of variation (CV)of different methods for tumor markers,for 6 times.The actual TEa of tumor markers in Shanghai External Quality Assessment Scheme was calculated by synthetic CV and compared with the Rilibak quality control guide in Germany and the Royal College of Pathologists in Australia (RCPA) quality and biological variation requirements.Results In 6 times of Shanghai External Quality Assessment Scheme,the actual TEa of alpha-fetoprotein(AFP),carcinoembryonic antigen(CEA),carbohydrate antigen(CA)125,CA153, CA19-9 and prostate-specific antigen(PSA)were 22.63%,22.43%,19.30%,21.56%,27.43% and 19.55%, which were closed to the Rilibak TEa requirements and biology variation TEa desirable requirements,but was superior to the TEa of RCPA requirements.Conclusions In Shanghai,the actual TEa of tumor markers in Shanghai External Quality Assessment Scheme is closed to the requirements of German Rilibak and slightly below the specification of the more strict Australian RCPA TEa,and TEa in Shanghai External Quality Assessment Scheme can meet the current quality level.