CLINICAL VALIDATION OF THE NEW ELSA-CA-125-II ASSAY - REPORT OF A EUROPEAN MULTICENTER EVALUATION

The ELSA-CA 125 II is a second-generation radioimmunoassay for the qua ntification of CA 125 in serum. In a multicentre study involving 49 fo llow-ups of patients with ovarian cancers, and 880 other patients, 2.8 % of healthy persons, 25% of 149 patients with benign gynaecological d iseases and 39% of 82 patients with benign non-gynaecological diseases had CA 125 levels above 35 U/ml. Using the 35 U/ml cut-off, sensitivi ties among epithelial ovarian cancers were found to be 85% in serous t umors, 41% in mucinous tumors and 83% in other types. During follow-up of patients with serous ovarian cancers, we observed an equivalent be haviour of both assays-first- and second-generation-with the clinical evolution. We also compared results obtained with other assays commerc ially available; these were significantly different when a polyclonal antibody was used in the sandwich assay. (C) 1995 Wiley-Liss, Inc.