Discrepancies in Clinical Laboratory Testing of Eligibility for Trastuzumab Therapy: Apparent Immunohistochemical False-Positives Do Not Get the Message

摘要: BACKGROUND: Several studies have reported what seem to be false-positive results using the Food and Drug Administration (FDA)–approved HercepTest (Dako Corp, Carpinteria, CA) profile Her-2/neu amplification overproduction in breast carcinoma. False-positive status has been based on comparisons with gene copy enumeration by fluorescence situ hybridization (FISH) immunohistochemistry (IMH) a monoclonal antibody. However, simple overexpression tumor cells that normal not evaluated profiling mRNA expression, ie, such cases could simply represent true-positive, transcriptionally upregulated overexpression. MATERIALS AND METHODS: Four hundred infiltrating ductal carcinomas of were IMH (CB11; Ventana Medical Systems, Inc, Tucson, AZ) polyclonal (HercepTest; Dako) antibodies after antigen retrieval (AR). A antibody sans AR (PCA/SAR) was also used. All stains scor...