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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.

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    Authors
    O'Grady, Anthony
    Allen, 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.ie
    Issue Date
    2010-12
    MeSH
    Automation
    Breast 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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    Citation
    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 Immunohistochemistry
    URI
    http://hdl.handle.net/10147/126470
    DOI
    10.1097/PAI.0b013e3181e3d893
    PubMed ID
    20661132
    Abstract
    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
    Article
    Language
    en
    ISSN
    1533-4058
    ae974a485f413a2113503eed53cd6c53
    10.1097/PAI.0b013e3181e3d893
    Scopus Count
    Collections
    Beaumont Hospital

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