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Determination of Estrogen Receptor in Breast Cancer Using Monoclonal Antibody Technology: Results of a Multicenter Study in the United States¹

Department of Human Oncology, Wisconsin Clinical Cancer Center, University of Wisconsin, Madison, Wisconsin 53792 [V. C. J.]; Department of Obstetrics and Gynecology, University of New York, Albany, New York [H. I. J.]; and Department of Surgery, The Oregon Health Sciences University, Portland, Oregon 97201 [E.J.K.]

Three laboratories compared their routine steroid binding assays with the Abbott estrogen receptor-enzyme immunoassay (ER-EIA) to determine ER in breast cancer cytosols. Each laboratory was first trained to use the ER-EIA kit and then performed routine proficiency panels to determine assay reproducibility. The frozen panels prepared from MCF-7 cytosol produced good intraassay results but the between assay coefficients of variation were frequently above 10%. Lyophilized MCF-7 cytosols produced better reproducibility upon repeated assay. One laboratory demonstrated that New England Nuclear steroid binding kits and the ER-EIA produced comparable results when MCF-7 lyophilized cytosols were used. The analysis of breast tumor samples demonstrated excellent linear correlation coefficients for each laboratory (>0.92 N approx. 60 samples each) but different slopes. The comparison of the ER-EIA with the New England Nuclear steroid binding assay produced a slope of 1.13. The ER-EIA appears to produce comparable results to the conventional steroid binding assays for the determination of ER in breast tumor cytosols.