MUC1 Gene–Derived Glycoprotein Assays for Monitoring Breast Cancer (CA 15-3, CA 27.29, BR): Are They Measuring the Same Antigen?

Abstract

Abstract Context.—There are 2 general types of assays measuring MUC1 gene–derived glycoprotein: assays for cancer antigen (CA) 15-3, which are sandwich assays, and assays for CA 27.29, which are competitive assays. These 2 types of assays measure slightly different parts of this tandem-repeat molecule. Across-method assay differences hinder the exchange of patient test values among integrated health care networks and among countries. Objective.—This report evaluates the method differences among these assays to determine if the differences between these assays are mainly related to variations in calibration or differences in analyte specificity. Design.—Data from 22 College of American Pathologists survey challenges were analyzed to compare 10 commercial assay methods for these 2 related analytes. In addition, data from 58 patient samples were analyzed to compare 3 of these assays. Results.—The linear correlation coefficients comparing the within-method medians of these proficiency test distributions were very high (>0.99) for all of the methods; however, the regression slopes varied from 0.836 to 1.095. The regression slopes for the patient specimens varied similarly, but the correlation coefficients were lower. Conclusions.—This study indicates that many of the test value differences for these measurements are due to differences in assay calibration rather than differences in the specificity of the assay measurement systems. Survey test data potentially could be used to help harmonize these assay differences.