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.

Hdl Handle:
http://hdl.handle.net/10147/126470
Title:
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, 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
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
Issue Date:
Dec-2010
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
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
ISSN:
1533-4058

Full metadata record

DC FieldValue Language
dc.contributor.authorO'Grady, Anthonyen
dc.contributor.authorAllen, Daviden
dc.contributor.authorHapperfield, Lisaen
dc.contributor.authorJohnson, Nicolaen
dc.contributor.authorProvenzano, Elenaen
dc.contributor.authorPinder, Sarah Een
dc.contributor.authorTee, Lilianen
dc.contributor.authorGu, Maien
dc.contributor.authorKay, Elaine Wen
dc.date.accessioned2011-03-31T08:36:57Z-
dc.date.available2011-03-31T08:36:57Z-
dc.date.issued2010-12-
dc.identifier.citationAn 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.en
dc.identifier.issn1533-4058-
dc.identifier.pmid20661132-
dc.identifier.doi10.1097/PAI.0b013e3181e3d893-
dc.identifier.urihttp://hdl.handle.net/10147/126470-
dc.description.abstractImmunohistochemistry (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.-
dc.language.isoenen
dc.subject.meshAutomation-
dc.subject.meshBreast Neoplasms-
dc.subject.meshFemale-
dc.subject.meshGuidelines as Topic-
dc.subject.meshHumans-
dc.subject.meshImmunohistochemistry-
dc.subject.meshIn Situ Hybridization, Fluorescence-
dc.subject.meshNeoplasm Invasiveness-
dc.subject.meshNeoplasm Proteins-
dc.subject.meshParaffin Embedding-
dc.subject.meshReceptor, erbB-2-
dc.subject.meshResearch Design-
dc.subject.meshSensitivity and Specificity-
dc.subject.meshStaining and Labeling-
dc.subject.meshTumor Markers, Biological-
dc.titleAn 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.en
dc.typeArticleen
dc.contributor.departmentDepartment of Pathology, R.C.S.I. Education & Research Centre, Beaumont Hospital, Dublin 9, Ireland. togrady@rcsi.ieen
dc.identifier.journalApplied immunohistochemistry & molecular morphology : AIMM / official publication of the Society for Applied Immunohistochemistryen
dc.description.provinceLeinster-
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