ArticleThe Journal of molecular diagnostics : JMD2008
Delineation of HER2 gene status in breast carcinoma by silver in situ hybridization is reproducible among laboratories and pathologists.
Article in The Journal of molecular diagnostics : JMD, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update.Archives of pathology & laboratory medicine · 2014Guideline
- Laminin 332 expression in breast carcinoma.Applied immunohistochemistry & molecular morphology : AIMM · 2012Trial
- Image analysis for bright-field HER2 in situ hybridization: validation for clinical use.Virchows Archiv : an international journal of pathology · 2025Article
- Trastuzumab-Mediated Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) Enhances Natural Killer Cell Cytotoxicity in HER2-Overexpressing Ovarian Cancer.International journal of molecular sciences · 2024Article
- HER2 in situ hybridization test in breast cancer: quantifying margins of error and genetic heterogeneity.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2021Article
- Evaluation of Immunohistochemistry-Equivocal (2+) HER2 Gene Status in Invasive Breast Cancer by Silver DNA in Situ Hybridization (SISH) and its Association with Clinicopathological Variables.Iranian journal of pathology · 2017Article
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- [Molecular methods in the diagnosis of sarcoma].Der Pathologe · 2011Review
- Testing for HER2 in Breast Cancer: A Continuing Evolution.Pathology research international · 2010Article
- Out of the darkness and into the light: bright field in situ hybridisation for delineation of ERBB2 (HER2) status in breast carcinoma.Journal of clinical pathology · 2010Review
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Authors and funding
12 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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).
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