Clinical validation of the new ELSA‐CA 125 II assay: Report of a european multicentre evaluation

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Abstract
The ELSA‐CA 125 II is a second‐generation radioimmunoassay for the quantification of CA 125 in serum. In a multicentre study involving 49 follow‐ups of patients with ovarian cancers, and 880 other patients, 2.8% of healthy persons, 25% of 149 patients with benign gynaecological diseases 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, sensitivities among epithelial ovarian cancers were found to be 85% in serous tumors, 41% in mucinous tumors and 83% in other types. During follow‐up of patients with serous ovarian cancers, we observed an equivalent behaviour of both assays—first‐ and second‐generation—with the clinical evolution. We also compared results obtained with other assays commercially available; these were significantly different when a polyclonal antibody was used in the sandwich assay. © 1995 Wiley‐ Liss, Inc.