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目的:评价两种方法学检测糖类抗原242（CA242）结果的可比性，以评估磁微粒化学发光法检测CA242是否能够满足临床的需求。方法:根据美国临床和实验室标准协会（CLSI）新指南EP9-A3文件要求，收集2018年1-7月首都医科大学附属北京康复医院和北京大学首钢医院肿瘤患者检测剩余的新鲜血清标本100例，以Fujirebio Diagnostics AB的酶联免疫法为参比方法，安图生物的磁微粒化学发光法为评估方法，对2种方法检测CA242的结果进行方法学比对和偏移评估。选择Passing-Baklok回归方法进行线性拟合，采用Wilcoxon符号秩检验及Spearman相关分析。结果:在4.31~295.63 U/ml范围内，2种方法学的CA242检测结果具有较好的相关性（n r=0.991，截距0.652）。参比方法和评估方法比较，差异无统计学意义［（53.75±6.69）U/ml比（56.11±6.86）U/ml，n t=0.246，n P=0.806］。将CA242的医学决定水平25.00 U/ml代入选取的最佳回归模型拟合方程，计算得到的相对偏移3.52%，<1/2n TEa±12.5%（n TEa为国家卫生健康委临床检验中心室间质量评审允许总误差），满足要求。n 结论:安图生物的磁微粒化学发光法和Fujirebio Diagnostics AB酶联免疫法检测CA242结果具有可比性，满足临床需要。“,”Objective:To compare the results of carbohydrate antigen 242 (CA242) detected by two different methods according to CLSI EP9-A3 guideline, then to evaluate whether the detection of CA242 by magnetic particle chemiluminescence method can meet the clinical needs.Methods:According to the new CLSI EP9-A3 guideline of American Society for clinical and laboratory standards, 100 fresh serum samples were collected from cancer patients from Beijing Rehabilitation Hospital Affiliated to Capital Medical University and Shougang Hospital of Peking University from January to July in 2018. The enzyme-linked immunosorbent assay (ELISA) of Fujirebio Diagnostics AB was used as the reference method, and the magnetic particle chemiluminescence method (MPCL) of Autobio was used as the evaluation method. Methodology comparison and bias estimation for CA242 data detected by these two methods were conducted. Wilcoxon signed rank test was used for data processing. The Passing-Baklok regression method was used for linear fitting. Wilcoxon signed rank test and Spearman correlation analysis were also performed.Results:Within the range of 4.31=295.63 U/ml, there was a good correlation between the results of CA242 detected by the two methods (n r=0.991, n b=0.652). There was no significant difference between the two groups ([53.75±6.69] U/ml vs [56.11±6.86] U/ml,n t=0.246,n P=0.806). When the medical determination level of CA242 (25 U/ml) was substituted into the best regression model fitting equation, the relative bias was 3.52%. It was less than 1/2 n TEa (±12.5%) and met the national requirements.n Conclusion:The detections of CA242 by the magnetic particle chemiluminescence of Autobio and the enzyme-linked immunosorbent assay of Fujirebio Diagnostics AB are comparable and both meet the clinical needs.