Alternative antibody for the detection of CA125 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® OV Monitor assay on the UniCel® DxI 800 Immunoassay System

Abstract

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

Clinical performance of LOCI™-based tumor marker assays for tumor markers CA 15-3, CA 125, CEA, CA 19-9 and AFP in gynecological cancers

“…Importantly, overall AUCs in ROC curves as well as sensitivities at specified cutoffs were comparable to other methods already used in routine diagnostics. 21 Our findings correspond further with current guidelines such as from the NACB that recommend CA 15-3 in breast cancer-though not for diagnosis but for monitoring of advanced disease and postoperative surveillance. 22 Although the application of CEA is still controversially discussed, 22 several studies have shown its importance in, for example, prediction and early detection of disease progression and metastasis.…”

Clinical Performance of CEA, CA19-9, CA15-3, CA125 and AFP in Gastrointestinal Cancer Using LOCI™-based Assays

“…In addition, for CA15-3 the analytical performance was accurate but not optimal and a difference in slope of 20-40% lower concentrations for the applied method was detected (23). Looking at the analytical performance of CA125, excellent correlation and only minimal differences in slopes and intercepts were reported (24). We conclude that analytical challenges and limitations are seen for most different methods applied in the routine measurement of tumor markers.…”

Hyaluronic acid–paclitaxel: effects of intraperitoneal administration against CD44(+) human ovarian cancer xenografts

“…Liver, kidneys and spleen were weighed for all mice. rather than the traditional OC125 and M11 antibodies for the detection of CA 125 [25,26].…”