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

Background: Cancer antigen CA15-3 antigen is known as a valuable marker for the management of breast cancer. Methods:The analytical and clinical performance of the Access ᮋ BR Monitor Immunoassay System (Beckman Coulter) was evaluated at five different European sites and compared with a reference system, defined as CA15-3 on the Elecsys ᮋ System (Roche Diagnostics). Results: Total imprecision (%CV) of the BR Monitor ranged between 5.5% and 11.7%, and inter-laboratory reproducibility between 3.4% and 5.1%. Linearity upon dilution showed a mean recovery of 98.5% (SD"9.1%). Endogenous interferents had no influence on BR Monitor levels (mean recoveries: hemoglobin 112%, bilirubin 111%, triglycerides 108%). There was no high-dose hook effect up to 13,540 kU/L. Clinical performance investigated in sera from 1811 individuals showed a general correlation between the Access BR Monitor and Elecsys CA15-3 (Rs0.797), with a slope of 1.383. CA15-3 serum levels, as measured by the BR Monitor, were low in healthy individuals (ns267, medians11.9 kU/L, 95th percentiles23.5 kU/L), higher in individuals with various benign diseases (ns549, medianss11.3-15.6 kU/L, 95th percentiless21.6-54.6 kU/L) and even higher in