Specificity of HercepTest in Determining HER-2/neu Status of Breast Cancers Using the United States Food and Drug Administration–Approved Scoring System
作者： Timothy W. Jacobs , Allen M. Gown , Hadi Yaziji , Melissa J. Barnes , Stuart J. Schnitt
DOI: 10.1200/JCO.1999.17.7.1983
关键词:
摘要: PURPOSE: To evaluate the specificity of HercepTest for Immunoenzymatic Staining (Dako Corp, Carpinteria, CA) determining HER-2/neu protein expression in breast cancer. MATERIALS AND METHODS: Forty-eight invasive cancers previously found to be HER-2/neu–negative by two different immunohistochemical (IHC) assays and not amplified gene fluorescence situ hybridization were studied using kit. was performed according manufacturer's guidelines, results scored on a 0 3+ scale United States Food Drug Administration (FDA)–approved grading system. In this system, cases as 2+ or are considered HER-2/neu–positive. RESULTS: Among these 48 cases, IHC score FDA-approved scoring system four (8.3%), 1+ 16 (33.3%), 21 (43.8%), seven (14.6%). Therefore, 58.4% categorized HER-2/neu–positive, kit HER-2/neu...
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