Alternative antibody for the detection of CA15-3 antigen: a European multicenter study for the evaluation of the analytical and clinical performance of the Access® BR Monitor assay on the UniCel® DxI 800 Immunoassay System

Abstract

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

Improved sensitivity for detection of breast cancer by combination of miR-34a and tumor markers CA 15-3 or CEA

“…When patients with benign breast diseases were considered as control groups, miR-34a was clearly superior to CEA and CA 15-3 alone. These results are in line with other studies that reported similar results for CA 15-3 for breast cancer detection [ 84 ].…”

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

“…In esophageal and gastric cancer, no marker was found to be of high diagnostic power. This was in line with other studies (22)(23)(24). Single elevated tumor markers were measured in patients suffering from hepatitis C with liver cirrhosis.…”

“…The evaluation of the analytical performance of CA19-9 using non LOCI™-based immunoassays revealed minimal differences in slopes and intercepts when comparing two different immunoassays; good correlation was shown for all patients in their collective (22). 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).…”

Method Comparison for Ca 15-3, Ca 19-9, and Ca 125 Determination Using the New Loci Technique of Dimension Vista 1500 and Immulite 2000 Xpi

“…[17][18][19] Lastly, correlations of the biomarker development in the course of specific cancer therapies with the therapeutic outcome and=or disease progression are important points to consider in clinical marker validation before introduction of a new method into clinical routine.…”

“…In particular, this comparison reveals the higher value scatter in the lower measuring range that is often observed in method comparison studies. [17][18][19] Possibly, this can be attributed to different antibody affinities resulting in discrepant values particularly when small amounts of antigens are present. Other studies compared each Vista marker with different methods and only over the entire measurement range.…”