基于EP9-A3文件对两仪器测定血清甲胎蛋白、癌胚抗原结果的可比性评价  

Comparability of the Results of Serum Alpha-fetoprotein and Carcinoembryonic Antigen Measured by the Two Instruments Based on the EP9-A3 Document

作　　者：宁萍 王雪婷 李奋荣 何静 徐小婕 王红红 云发超 NING Ping;WANG Xue-ting;LI Fen-rong;HE Jing;XU Xiao-jie;WANG Hong-hong;YUN Fa-chao(Department of Laboratory Medicine,Urumqi Hospital of Traditional Chinese Medicine,Urumqi 830000,Xinjiang,China;Department of Integrated Traditional Chinese and Western Medicine,General Hospital of Xinjiang Military Region,Urumqi 830000,Xinjiang,China)

机构地区：[1]乌鲁木齐市中医医院检验科,新疆乌鲁木齐830000 [2]新疆军区总医院中西医结合科,新疆乌鲁木齐830000

出　　处：《医学信息》2024年第5期138-142,共5页Journal of Medical Information

摘　　要：目的 探讨甲胎蛋白(AFP)、癌胚抗原(CEA)在2检测系统上测定结果的可比性。方法 以罗氏cobas e 601全自动化学发光免疫分析仪为参比方法(X),透景Tesmi F4000全自动流式荧光发光免疫分析仪作待测方法(Y),选择待测方法(Y)的检测线性内样本(AFP、CEA各40例)在两仪器上测定。根据美国临床和实验室标准化协会(CLSI)的EP9-A3文件,以1/2TEa(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)为评判标准,对检测结果进行方法比对、偏倚评估及临床可接受程度分析。结果 两仪器所测AFP、CEA结果无统计学意义(P>0.05),计算所得偏倚均在允许误差范围内(均≤12.5%),线性回归方程的相关性良好(r2>0.95),在医学决定水平处的偏倚为临床可接受。结论 在透景流式荧光发光检测系统测定范围内,AFP和CEA在两个仪器中的检测结果呈显著相关,二者在两个医学决定水平上的相对偏差在临床可接受水平之内,即两台检测仪器间的测定果可比性良好,各级医疗机构可据此来选择合适的仪器。Objective To investigate the comparability of the results of alpha-fetoprotein(AFP)and carcinoembryonic antigen(CEA)on two detection systems.Methods The Roche cobas e 601 automatic chemiluminescence immunoassay analyzer was used as the reference method(X),and the Tesmi F4000 automatic flow fluorescence immunoassay analyzer was used as the test method(Y).The detection linear samples(AFP,CEA,with 40 cases in each sample)of the test method(Y)were selected and measured on the two instruments.According to the EP9-A3 document of the American Clinical and Laboratory Standards Institute(CLSI),1/2TEa(TEa is the total allowable error of the external quality assessment of the National Health Commission Clinical Laboratory Center)was used as the evaluation standard to compare the test results,evaluate the bias and analyze the clinical acceptability.Results The results of AFP and CEA measured by the two instruments were not statistically significant(P>0.05).The calculated bias was within the allowable error range(all≤12.5%).The correlation of the linear regression equation was good(r2>0.95),and the bias at the medical decision level was clinically acceptable.Conclusion Within the measurement range of the flow-through fluorescence luminescence detection system,the detection results of AFP and CEA in the two instruments are significantly correlated,and the relative deviations of the two at the two medical decision levels are within the clinically acceptable level,that is,the measurement results between the two detection instruments are comparable,and medical institutions at all levels can choose the appropriate instrument accordingly.

关 键 词：EP9-A3 甲胎蛋白 癌胚抗原 测定方法 偏倚评估 

分 类 号：R446.1[医药卫生—诊断学] R735.7[医药卫生—临床医学]