Spona J, Kessler A C, Deeg R
J Clin Chem Clin Biochem. 1987 Jan;25(1):53-9. doi: 10.1515/cclm.1987.25.1.53.
The use of a new monoclonal enzyme immunoassay (EIA) for the carcinoembryonic antigen (CEA) (Enzymun-Test CEA) was evaluated in a multi-centre study. Fifteen different laboratories [participated in the study. Data from the investigation were analysed in terms of precision, sensitivity, specificity and correlation with other test methods. The intra-assay coefficient of variation was between 1.3% at 23.0 microg/l CEA and 13.9% at 1.3 microg/l CEA. Inter-assay reproducibility ranged from 3.6% to 19.2%. The apparent sensitivity of the new EIA for CEA was approx. 0.5 microg/l CEA. The findings indicate that lipaemic and haemolytic sera and samples taken from icteric, rheumatic and dialysis patients did not have any influence on the results. There was no evidence that drugs commonly used in the treatment of carcinoma patients have any influence on the assay results. A good correlation between the new EIA for CEA and six other CEA enzyme immunoassay or radioimmunoassay methods was registered. These results seem to be of significance in particular for the monitoring of therapy for carcinoma patients. The new EIA for CEA exhibits a high degree of sensitivity, specificity and reproducibility.
在一项多中心研究中对一种用于癌胚抗原（CEA）的新型单克隆酶免疫测定法（酶免疫检测CEA）进行了评估。十五个不同的实验室参与了该研究。根据精密度、灵敏度、特异性以及与其他检测方法的相关性对研究数据进行了分析。批内变异系数在CEA浓度为23.0微克/升时为1.3%，在CEA浓度为1.3微克/升时为13.9%。批间再现性范围为3.6%至19.2%。新型CEA酶免疫测定法的表观灵敏度约为0.5微克/升CEA。研究结果表明，脂血和溶血血清以及取自黄疸、风湿和透析患者的样本对结果没有任何影响。没有证据表明常用于治疗癌症患者的药物对检测结果有任何影响。新型CEA酶免疫测定法与其他六种CEA酶免疫测定法或放射免疫测定法之间具有良好的相关性。这些结果似乎对癌症患者的治疗监测尤为重要。新型CEA酶免疫测定法具有高度的灵敏度、特异性和再现性。
