An immunohistochemical and fluorescence in situ hybridization-based comparison between the Oracle HER2 Bond Immunohistochemical System, Dako HercepTest, and Vysis PathVysion HER2 FISH using both commercially validated and modified ASCO/CAP and United Kingdom HER2 IHC scoring guidelines.
Authors
O'Grady, AnthonyAllen, David
Happerfield, Lisa
Johnson, Nicola
Provenzano, Elena
Pinder, Sarah E
Tee, Lilian
Gu, Mai
Kay, Elaine W
Affiliation
Department of Pathology, R.C.S.I. Education & Research Centre, Beaumont Hospital, Dublin 9, Ireland. togrady@rcsi.ieIssue Date
2010-12MeSH
AutomationBreast Neoplasms
Female
Guidelines as Topic
Humans
Immunohistochemistry
In Situ Hybridization, Fluorescence
Neoplasm Invasiveness
Neoplasm Proteins
Paraffin Embedding
Receptor, erbB-2
Research Design
Sensitivity and Specificity
Staining and Labeling
Tumor Markers, Biological
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An immunohistochemical and fluorescence in situ hybridization-based comparison between the Oracle HER2 Bond Immunohistochemical System, Dako HercepTest, and Vysis PathVysion HER2 FISH using both commercially validated and modified ASCO/CAP and United Kingdom HER2 IHC scoring guidelines. 2010, 18 (6):489-93 Appl. Immunohistochem. Mol. Morphol.Journal
Applied immunohistochemistry & molecular morphology : AIMM / official publication of the Society for Applied ImmunohistochemistryDOI
10.1097/PAI.0b013e3181e3d893PubMed ID
20661132Abstract
Immunohistochemistry (IHC) is used as the frontline assay to determine HER2 status in invasive breast cancer patients. The aim of the study was to compare the performance of the Leica Oracle HER2 Bond IHC System (Oracle) with the current most readily accepted Dako HercepTest (HercepTest), using both commercially validated and modified ASCO/CAP and UK HER2 IHC scoring guidelines. A total of 445 breast cancer samples from 3 international clinical HER2 referral centers were stained with the 2 test systems and scored in a blinded fashion by experienced pathologists. The overall agreement between the 2 tests in a 3×3 (negative, equivocal and positive) analysis shows a concordance of 86.7% and 86.3%, respectively when analyzed using commercially validated and modified ASCO/CAP and UK HER2 IHC scoring guidelines. There is a good concordance between the Oracle and the HercepTest. The advantages of a complete fully automated test such as the Oracle include standardization of key analytical factors and improved turn around time. The implementation of the modified ASCO/CAP and UK HER2 IHC scoring guidelines has minimal effect on either assay interpretation, showing that Oracle can be used as a methodology for accurately determining HER2 IHC status in formalin fixed, paraffin-embedded breast cancer tissue.Item Type
ArticleLanguage
enISSN
1533-4058ae974a485f413a2113503eed53cd6c53
10.1097/PAI.0b013e3181e3d893
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