安图Autolumo A2000化学发光仪检测常规肿瘤标志物应用评估分析  

Research on the application evaluation of the routine test of tumor markers with Autolumo A2000

作　　者：黄东标[1] 陈威[1] 胡轶[2] 

机构地区：[1]磐安县人民医院检验科,浙江磐安322300 [2]金华市中心医院检验科,浙江金华321000

出　　处：《中国卫生检验杂志》2015年第16期2708-2710,共3页Chinese Journal of Health Laboratory Technology

基　　金：浙江省医药卫生科技计划一般项目(2013KYA220);浙江省金华市科技重点项目(2012-3-022)

摘　　要：目的通过安图Autolumo A2000全自动化学发光仪与罗氏Cobas E601,检测甲胎蛋白(AFP)、癌胚抗原(CEA)、糖类抗原125(CA125)、糖类抗原199(CA199)结果的可比性、偏倚评估,以分析Autolumo A2000的临床应用可接受度。方法根据美国临床实验室标准化委员会(NCCLS)EP9—A2文件的要求,采用罗氏Cobas E601发光仪为比较方法,安图Autolumo A2000为实验方法,对40份患者新鲜血清样品进行检测,分析实验方法存在的相对偏差和医学决定水平处的系统误差。结果两台仪器AFP、CEA、CA125、CA199 4个项目检测的相关系数r分别为0.998 5、0.997 1、0.981 1、0.988 8。在参考值上限和医学决定水平处的相对偏差分别为AFP(10.4、7.40)、CEA(6.27、6.24)、CA125(1.58、1.16)、CA199(4.43、8.79)。结论安图Autolumo A2000在常规肿瘤标志物的检测与罗氏Cobas E601有较好的相关性,医学决定水平处的偏倚在临床应用可接受范围,使用新的仪器检测相同项目时,应进行比对分析和偏倚评估,保证实验室结果的可比性。Objective In order to evaluate the clinical acceptability of Auto Lumo A2000,we analyzed the comparability and the bias of the test results of alpha- fetoprotein（ AFP）,carcinoembryonic antigen（ CEA）,carbohydrate antigen 125（ CA125）,carbohydrate antigen 199（ CA199） with Auto Lumo A2000,compared with a reference method,defined as Cobas E160 of Roche.Methods According to the requirements of EP9—A2 documents of NCCLS,40 fresh serum samples were detected with the above two methods,so as to analyze the relative deviation and the systematic error of the medical decision level. Results The coefficient of correlation to the values of the four projects mentioned above by Cobas E160 of Roche and Auto Lumo A2000 were0. 998 5,0. 997 1,0. 981 1 and 0. 988 8 respectively,and the systematic deviations of MDL were AFP（ 10. 4,7. 40）,CEA（ 6. 27,6. 24）,CA125（ 1. 58,1. 16）,CA199（ 4. 43,8. 79）. Conclusion Auto Lumo A2000 was in good correlation with Cobas E160 of Roche as for the routine test of tumor markers,and the systematic deviation fell into the acceptable range of MDL.For the sake of assuring the experimental results,the comparative analysis and deviation evaluation were indispensable when the new instruments were applied to the same project.

关 键 词：甲胎蛋白 癌胚抗原 糖类抗原 比对分析 

分 类 号：R730.4[医药卫生—肿瘤]