Detection of Ca antigen in sera from normal individuals and patients with benign and malignant breast disease.

Two assay procedures, an inhibition radioimmunoassay (Inhibition-RIA) and an immunoradiometric assay (IRMA), were established for the detection of circulating tumour-associated Ca antigen. There was a good correlation between results (r = 0.987) but the Inhibition-RIA was selected for extended tests on human sera from patients with breast disease because of its greater ease and economy in use. Circulating Ca antigen was not exclusive to malignancy and the level failed to discriminate between patients with primary carcinoma and those with benign disease. Ca antigen was present in sera of 100 healthy individuals (median 7.1 micrograms ml-1, range 1.8-24.4 micrograms ml)-1, 39 patients with benign disease (median 9.9 micrograms ml-1, range 2.5- greater than 100 micrograms ml-1) and in 67 patients with primary carcinoma (median 11.0 micrograms ml-1, range 3.8- greater than 100 micrograms ml-1). Elevated Ca antigen levels were found in 50% of patients with metastatic spread (median 30.7 micrograms ml-1, range 8.2- greater than 100 micrograms ml-1) and in some patients with primary disease but further studies are needed to determine the prognostic significance. Immunochemical studies confirmed that Ca antigen is a normal serum product but its function is unclear.