不同允许总误差在肿瘤标志物检测性能评价与质量控制规则选择中的应用

Application of different allowed total error in the performance evaluation of tumor marker determination and selecting quality control rule

目的评价不同国际标准及生物学变异要求提供的允许总误差(TEa)对肿瘤标志物检测的分析性能量化的差异,并根据六西格玛(6σ)参数选择和优化质量控制规则。方法应用6σ方法计算甲胎蛋白(AFP)、癌胚抗原(CEA)、前列腺特异性抗原(PSA)、糖抗原(CA)199、CA125、CA153项目的σ水平,σ=[TEa-偏倚]/变异系数(CV)。CV由2009年6至12月份室内质量控制结果计算,偏倚以参加室间质评的平均偏倚计算。TEa分别引用美国临床实验室改进法案修正案(CLIA′88)、德国Rilibak质控指南及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要求。结果在罗氏E601化学发光分析系统上,AFP、CEA、PSA、CA199、CA125、CA153的σ水平从0.71～9.82不等,在不同TEa要求下分析性能表现不同,可以参照项目的σ水平选择不同室内质量控制规则。结论 TEa计算的σ水平评价实验室肿瘤标志物的分析性能,采用不同的质量控制规则,可经济、合理的开展室内质量控制。

Objective To study the application of different allowed total error（TEa） in the performance evaluation of tumor marker determination,and select and optimize the quality control rules according to 6 sigma（6σ）.Methods The σ levels of alpha-fetoprotein（AFP）,carcino-embryonic antigen（CEA）,prostate specific antigen（PSA）,carbohydrate antigen（CA）199,CA125 and CA153 were calculated according to the formula： σ=（TEa-bias）/coefficient of variation（CV）.The CV and bias were collected and calculated from intra quality control from June to December 2009 and the mean value of inter quality control,respectively.TEa was quoted from the Clinical Laboratory Improvement Amendments 88（CLIA′88）,Rilibak（German guidelines for quality）,the requirements of the Royal College of Pathologists of Australasia（RCPA） and biological variation data.Results The σ values of tumor markers such as AFP,CEA,PSA,CA199,CA125 and CA153 were from 0.71-9.82 in Roche E601 chemiluminescence analyzing system.The performance expressions were different with different TEa.The quality control rules should be chosen appropriately according to different levels.Conclusions Clinical laboratory can select different quality control rules in line with σ level calculated by different TEa in order to perform intra quality control economically and reasonably.