Background: Cancer antigen CA125 is known as a valuable marker for the management of ovarian cancer. Methods: The analytical and clinical performance of the Access OV Monitor Immunoassay System (Beckman Coulter) was evaluated at five different European sites and compared with a reference system, defined as CA125 on the Elecsys System (Roche Diagnostics). Results: Total imprecision (%CV) of the OV Monitor ranged between 3.1% and 8.8%, and inter-laboratory reproducibility between 4.7% and 5.0%. Linearity upon dilution showed a mean recovery of 100% (SDq8.1%). Endogenous interferents had no influence on OV Monitor levels (mean recoveries: hemoglobin 107%, bilirubin 103%, triglycerides 103%). There was no high-dose hook effect up to 27,193 kU/L. Clinical performance investigated in sera from 1811 individuals showed a good correlation between the Access OV Monitor and Elecsys CA125 (Rs0.982, slopes0.921, interceptsq1.951). OV Monitor serum levels were low in healthy individuals (ns267, medians9.7 kU/L, 95th percentiles30.8 kU/L), higher in individuals with various benign diseases (ns549, medianss10.9-16.4 kU/L, 95th percentiless44.2-355 kU/L) and even higher in individuals suffering from various cancers (ns995, medianss12.4-445