A formalin-fixed, paraffin-processed cell line standard for quality control of immunohistochemical assay of HER-2/neu expression in breast cancer

Anthony Rhodes, Bharat Jasani, Jérôme Couturier, Mark J. McKinley, John M. Morgan, Andrew R. Dodson, Hossein Navabi, Keith D. Miller, André J. Balaton

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74 Citations (Scopus)

Abstract

To ensure the accuracy and reproducibility of immunohistochemical assays for determining HER-2/neu status of patients with breast cancer, a reliable standard for monitoring assay sensitivity is necessary. We optimally fixed and paraffin processed human ovarian and breast carcinoma cell lines SKOV-3, MDA-MB-453, BT-20, and MCF-7 in quantities sufficient to meet the needs of a laboratory for the foreseeable future. The material was tested, alongside Hercep Test kit cell lines (DAKO, Carpinteria, CA), by 7 breast cancer centers in the United Kingdom and France with different immunohistochemical assays and markers. The cell lines also were analyzed by fluorescence in situ hybridization (FISH) by 2 centers using HER-2/neu kits. FISH produced 100% agreement between the 2 centers: SKOV-3 and MDA-MB-453 showed HER-2/neu amplification and BT-20 and MCF-7 did not. Immunohistochemical analysis and a common evaluation method produced 100% agreement that SKOV-3 and MCF-7 showed 3+ and zero HER-2/neu overexpression, respectively. For MDA-MB-453, there was 71% (5/7) concordance of 2+ immunohistochemical staining and 86% (6/7) concordance of zero or 1+ staining for BT-20. The cell lines provide a valuable standard for gauging HER-2/neu assay sensitivity irrespective of the antibody, antigen retrieval system, detection system, or method of evaluation used.

Original languageEnglish
Pages (from-to)81-89
Number of pages9
JournalAmerican Journal of Clinical Pathology
Volume117
Issue number1
DOIs
Publication statusPublished - Jan 21 2002

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Keywords

  • Cell line standard
  • Fluorescence in situ hybridization
  • HER-2/neu
  • Immunohistochemistry
  • Quality control

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

Cite this

Rhodes, A., Jasani, B., Couturier, J., McKinley, M. J., Morgan, J. M., Dodson, A. R., Navabi, H., Miller, K. D., & Balaton, A. J. (2002). A formalin-fixed, paraffin-processed cell line standard for quality control of immunohistochemical assay of HER-2/neu expression in breast cancer. American Journal of Clinical Pathology, 117(1), 81-89. https://doi.org/10.1309/4NCM-QJ9W-QM0J-6QJE