- Paper Report
- Open Access
Quality control of immunohistochemical assay of HER-2/neu expression
- George Skliris1
© Biomed Central Ltd 2002
- Received: 14 March 2002
- Accepted: 19 March 2002
- Published: 1 December 2002
- Breast and ovarian cell lines, FISH, HER-2/neu, immunohistochemistry
HER-2/neu (c-erb-2) gene encodes a membrane receptor related to the epidermal growth factor receptor and its amplification has been correlated with a shorter disease free interval in breast cancer patients. Recently, clinical trials have shown that treatment with an antibody can block growth of cells expressing HER-2/neu and prolong survival of patients. An immunohistochemical (IHC) test and fluorescence in situ hybridisation (FISH) are used to predict HER-2/neu status. IHC is economic to use and included in routine diagnostic services. However, IHC sensitivity varies between laboratories. In order to ensure reproducibility of results a standard control is needed so that day-to-day variation can be monitored. The objective of this study was to develop a control for HER-2/neu histochemical detection by investigating four breast and ovarian cell lines.
A 100% agreement between testing centres using FISH revealed that MDA-MB-453 and SKOV-3 cell lines showed HER-2/neu amplification, while BT-20 and MCF-7 were negative. SKOV-3 exhibited a score of 3+ HER-2/neu protein overexpression by IHC and gene amplification with FISH; in contrast, MCF-7 cells showed neither protein expression nor gene amplification (0 score). For BT-20 cells an 86% concordance (6/7) was observed between a 0 or 1+ score by IHC and no amplification detected by FISH, while 71% concordance between an HIC score of 2+ and amplification detected by FISH was shown for MDA-MB-453. The sensitivity of the developed cell-line control was 3+, 2+, 2+ and 0 with CB11 and 3+, 2+, 1+, 0 with the HercepTest or DAKO antibody (SKOV-3, MDA-MB-453, BT-20 and MCF-7 respectively).
Cell culture, IHC, FISH, antibodies (CB11 clone, HercepTest and DAKO polyclonal)
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