| Abstract: |
BR27.29 is one of several carcinoma-associated mucin antigens with clinical utility as a marker for the management of breast cancer patients. The Ciba Corning ACS:180 BR assay is a fully automated, competitive, chemiluminescent assay for the quantitative determination of BR27.29 in serum. The performance characteristics of this assay were evaluated to determine the sensitivity (3.5 U/ml), precision (2.0-4.2%), linearity (at least 390 U/ml), and normal reference range for the assay (0-37 U/ml). The automated procedure also was compared with the PDA approved Truquant® BR™ RIA manual procedure for BR27.29. A comparative analysis of 203 specimens yielded the equation y=1.04x+6 (where x = manual and y = automated) indicating the data were well correlated (r=0.956). Likewise, serial studies indicated similar clinical correlations for both assays. The Ciba Corning ACS:180 BR assay compared favorably with the Truquant BR RIA assay with the advantages of automation (rapidity, reliability and reproducibility) and the benefit of a non-isotopic procedure. |
