JMD ASIP MEMBERSHIP
HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Originally published online as doi:10.2353/jmoldx.2008.080052 on October 2, 2008

Published online before print October 2, 2008
This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Supplemental Material
Right arrow All Versions of this Article:
jmoldx.2008.080052v1
10/6/527    most recent
Right arrow Purchase Article
Right arrow View Shopping Cart
Services
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow reprints & permissions
Citing Articles
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Carbone, A.
Right arrow Articles by Verderio, P.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Carbone, A.
Right arrow Articles by Verderio, P.
Journal of Molecular Diagnostics 2008, Vol. 10, No. 6
Copyright © 2008 American Society for Investigative Pathology & Association for Molecular Pathology
DOI: 10.2353/jmoldx.2008.080052

Delineation of HER2 Gene Status in Breast Carcinoma by Silver in Situ Hybridization is Reproducible among Laboratories and Pathologists

Antonino Carbone*, Gerardo Botti{dagger}, Annunziata Gloghini{ddagger}, Gianni Simone§, Mauro Truini, Maria Pia Curcio{dagger}, Patrizia Gasparini*, Anita Mangia§, Tiziana Perin{ddagger}, Sandra Salvi, Adele Testi* and Paolo Verderio**

From the Department of Pathology, * National Cancer Institute of Milan, Milan, Italy; Department of Pathology, {dagger} National Cancer Institute "G. Pascale" of Naples, Naples, Italy; Diagnostic Immunohistochemistry and Molecular Pathology, {ddagger} Division of Pathology, Centro di Riferimento Oncologico, Aviano, Italy; Department of Pathology, § Ospedale Oncologico, Bari, Italy; Department of Diagnostic Technologies, National Cancer Institute of Genoa, Genoa, Italy and Medical Statistics and Biometry, ** National Cancer Institute of Milan, Milan, Italy

An automated enzyme metallographic silver in situ hybridization method (SISH) has been reported to successfully determine human epidermal growth factor receptor 2 (HER2) gene amplification. We evaluated the staining and interpretative reproducibility of the HER2 SISH assay at five laboratories and compared SISH results with other in situ hybridization (ISH) methods. The HER2 gene status of 89 breast carcinomas was analyzed in parallel using manual dual-color fluorescence ISH, manual chromogenic ISH, and bright-field automated SISH. A total of 1098 SISH-stained slides were evaluated. For comparison, all specimens were stained by 4B5 immunohistochemistry for HER2 protein expression. Interpretation was performed by pathologists at five different laboratories using the algorithms provided by the manufacturers and the guidelines of American Society of Clinical Oncology/College of American Pathologists. Staining and interpretative reproducibility were measured through the computation of weighted kappa statistics. Following the optimization of SISH staining, 1077/1098 (98%) of slides were evaluable. Excellent reproducibility and efficacy of HER2 SISH staining, and interobserver interpretation (Kw = 0.91), were observed among five sites. For the 89 invasive breast cancer cases, the overall rate of concordance between consensus 4B5 and consensus SISH, fluorescence ISH, and chromogenic ISH was 96.6% (86/89), 97.8% (87/89), and 96.6% (86/89), respectively. Overall concordance between positive and negative SISH and fluorescence ISH results, as well as between individual and consensus positive and negative SISH results, was excellent (P < 0.001).






HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
Copyright © 2008 by the American Society for Investigative Pathology and the Association for Molecular Pathology.