title: A formalin-fixed, paraffin-processed cell line standard for quality control of immunohistochemical assay of HER-2/neu expression in breast cancer.
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 HercepTest 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.
authors.affiliation: United Kingdom National External Quality Assessment Scheme for Immunocytochemistry and the Department of Histopathology, University College London Medical School, England.
authors.forename: Anthony
authors.initials: A
authors.lastname: Rhodes
authors.forename: Bharat
authors.initials: B
authors.lastname: Jasani
authors.forename: Jérĵme
authors.initials: J
authors.lastname: Couturier
authors.forename: Mark J
authors.initials: MJ
authors.lastname: McKinley
authors.forename: John M
authors.initials: JM
authors.lastname: Morgan
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Dodson
authors.forename: Hossein
authors.initials: H
authors.lastname: Navabi
authors.forename: Keith D
authors.initials: KD
authors.lastname: Miller
authors.forename: André J
authors.initials: AJ
authors.lastname: Balaton
mesh_terms: D001943:Breast Neoplasms / Q000276:immunology / Q000473:pathology*; D005260:Female; D005557:Formaldehyde; D006801:Humans; D007150:Immunohistochemistry / Q000592:standards; D017404:In Situ Hybridization, Fluorescence; D016612:Paraffin Embedding / Q000592:standards; D011786:Quality Control; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*; D012015:Reference Standards; D016707:Tissue Fixation / Q000592:standards; D014407:Tumor Cells, Cultured
chemical_list: D005557:Formaldehyde; D018719:Erb-b2 Receptor Tyrosine Kinases