Multi-centre study of a new CEA enzyme immunoassay using monoclonal antibodies

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.