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

被引：8
作者：
O'Grady, Anthony [1 ]
Allen, David [1 ]
Happerfield, Lisa [2 ]
Johnson, Nicola [2 ]
Provenzano, Elena [2 ]
Pinder, Sarah E. [3 ]
Tee, Lilian [4 ]
Gu, Mai [4 ]
Kay, Elaine W. [1 ]
机构：
[1] Beaumont Hosp, Dept Pathol, RCSI Educ & Res Ctr, Dublin 9, Ireland
[2] Addenbrookes Hosp, Dept Histopathol, Cambridge, England
[3] Kings Coll London, Guys & St Thomass Hosp, Dept Res Oncol, London WC2R 2LS, England
[4] Oncotech Inc, Tustin, CA USA
来源：
APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY | 2010年 / 18卷 / 06期
关键词：
immunohistochemistry; fluorescence in situ hybridization; HER2; scoring guidelines; HUMAN-BREAST-CANCER; OF-CLINICAL-ONCOLOGY; GENE AMPLIFICATION; HER-2/NEU STATUS; QUANTITATION; TRASTUZUMAB; SENSITIVITY; CARCINOMA; ONCOGENE; FOOD;
D O I：
10.1097/PAI.0b013e3181e3d893
中图分类号：
R602 [外科病理学、解剖学]; R32 [人体形态学];
学科分类号：
100101 ;
摘要：
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 x 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.
引用
收藏
页码：489 / 493
页数：5
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