PMID- 11789735 OWN - NLM STAT- MEDLINE DCOM- 20020122 LR - 20141120 IS - 0002-9173 (Print) IS - 0002-9173 (Linking) VI - 117 IP - 1 DP - 2002 Jan TI - A formalin-fixed, paraffin-processed cell line standard for quality control of immunohistochemical assay of HER-2/neu expression in breast cancer. PG - 81-9 AB - 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. FAU - Rhodes, Anthony AU - Rhodes A AD - United Kingdom National External Quality Assessment Scheme for Immunocytochemistry and the Department of Histopathology, University College London Medical School, England. FAU - Jasani, Bharat AU - Jasani B FAU - Couturier, Jerjme AU - Couturier J FAU - McKinley, Mark J AU - McKinley MJ FAU - Morgan, John M AU - Morgan JM FAU - Dodson, Andrew R AU - Dodson AR FAU - Navabi, Hossein AU - Navabi H FAU - Miller, Keith D AU - Miller KD FAU - Balaton, Andre J AU - Balaton AJ LA - eng PT - Journal Article PL - England TA - Am J Clin Pathol JT - American journal of clinical pathology JID - 0370470 RN - 1HG84L3525 (Formaldehyde) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM CIN - Am J Clin Pathol. 2002 Jan;117(1):7-8. PMID: 11789733 MH - Breast Neoplasms/immunology/*pathology MH - Female MH - Formaldehyde MH - Humans MH - *Immunohistochemistry/standards MH - In Situ Hybridization, Fluorescence MH - Paraffin Embedding/standards MH - Quality Control MH - Receptor, ErbB-2/*analysis MH - Reference Standards MH - Tissue Fixation/standards MH - Tumor Cells, Cultured EDAT- 2002/01/16 10:00 MHDA- 2002/01/23 10:01 CRDT- 2002/01/16 10:00 PHST- 2002/01/16 10:00 [pubmed] PHST- 2002/01/23 10:01 [medline] PHST- 2002/01/16 10:00 [entrez] AID - 10.1309/4NCM-QJ9W-QM0J-6QJE [doi] PST - ppublish SO - Am J Clin Pathol. 2002 Jan;117(1):81-9. doi: 10.1309/4NCM-QJ9W-QM0J-6QJE.