Fleisher M, Nisselbaum J S, Loftin L, Smith C, Schwartz M K
Clin Chem. 1984 Feb;30(2):200-5.
We have evaluated Roche Diagnostics' RIA-CEA and Abbott Diagnostics' EIA-CEA methods for precision, normal reference interval, concordance, and correlation of malignant disease with increase in carcinoembryonic antigen (CEA) in plasma. In examining concordance, we used data on 138 patients with primary carcinomas of the breast, colon, lung, or pancreas, each further classified by extent of dissemination. We find the two methods to be comparably precise. The respective upper reference limits of normal for the Roche and Abbott methods were determined to be 5.0 micrograms/L and 4.6 micrograms/L. The regression equation for a log transformation of the 177 data points is y = 0.966x + 0.03, where x = Roche and y = Abbott, with a correlation coefficient of 0.948. According to the criteria we used, the concordance was 78.7%. The largest discordance was observed in widely disseminated disease states and in cancers of the colon and pancreas. Paired data analysis of discordance indicated greater increases in apparent CEA by the Abbott method in most colon cancers with liver involvement; six of the eight discordant pancreatic cancers had higher Roche-CEA values. CEA heterogeneity and the role of the liver in CEA metabolism appear to contribute to the observed differences. We show why the two methods should not be used interchangeably, and that baseline values for CEA must be established for each method.
我们评估了罗氏诊断公司的放射免疫分析法(RIA-CEA)和雅培诊断公司的酶免疫分析法(EIA-CEA)在精密度、正常参考区间、一致性以及血浆中癌胚抗原(CEA)升高与恶性疾病的相关性方面的表现。在检查一致性时,我们使用了138例乳腺癌、结肠癌、肺癌或胰腺癌原发性癌患者的数据,每种癌症再根据播散程度进一步分类。我们发现这两种方法的精密度相当。罗氏和雅培方法各自的正常上限参考值分别确定为5.0微克/升和4.6微克/升。对177个数据点进行对数转换后的回归方程为y = 0.966x + 0.03,其中x = 罗氏法,y = 雅培法,相关系数为0.948。根据我们使用的标准,一致性为78.7%。在广泛播散的疾病状态以及结肠癌和胰腺癌中观察到最大的不一致性。对不一致性的配对数据分析表明,在大多数伴有肝脏受累的结肠癌中,雅培法测得的CEA明显升高;8例不一致的胰腺癌中有6例罗氏-CEA值更高。CEA的异质性以及肝脏在CEA代谢中的作用似乎导致了观察到的差异。我们说明了为什么这两种方法不应互换使用,并且必须为每种方法确定CEA的基线值。