The reliability of rabbit monoclonal antibodies in the immunohistochemical assessment of estrogen receptors, progesterone receptors, and HER2 in human breast carcinomas.

The reliability of the rabbit monoclonal antibodies SP1, SP2, SP3, and 4B5 was immunohistochemically assessed on a range of 96 invasive breast carcinomas and the results compared with those achieved with established antibody markers for estrogen receptors (6F11), progesterone receptors (PgR636), and HER2 (polyclonal A0485 and clone CB11), with HER2 status validated by fluorescence in situ hybridization (FISH) and silver in situ hybridization. Optimal results depended on the duration of microwave antigen-retrieval time and the use of a high pH buffer for rabbit and mouse estrogen receptor antibodies (SP1 and 6F11), although only on antigen-retrieval duration for the progesterone receptors SP2 and PgR636. The highest rate of concordance between HER2 overexpression and HER2 gene amplification was with the rabbit monoclonal antibodies (SP3 and 4B5) and FISH. Rabbit monoclonal antibodies are reliable alternatives to established antibody markers for the immunohistochemical testing of estrogen receptors, progesterone receptors, and HER2 in breast cancer.

[1]  Anthony Rhodes,et al.  American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. , 2010, Archives of pathology & laboratory medicine.

[2]  D. Allred.  Commentary: hormone receptor testing in breast cancer: a distress signal from Canada. , 2008, The oncologist.

[3]  B. Jasani,et al.  Potential for false-positive staining with a rabbit monoclonal antibody to progesterone receptor (SP2): findings of the UK National External Quality Assessment Scheme for Immunocytochemistry and FISH highlight the need for correct validation of antibodies on introduction to the laboratory. , 2008, American journal of clinical pathology.

[4]  H. Höfler,et al.  Comparison of automated silver enhanced in situ hybridisation (SISH) and fluorescence ISH (FISH) for the validation of HER2 gene status in breast carcinoma according to the guidelines of the American Society of Clinical Oncology and the College of American Pathologists , 2007, Virchows Archiv.

[5]  T. Grogan,et al.  A New Rabbit Monoclonal Antibody (4B5) for the Immunohistochemical (IHC) Determination of the HER2 Status in Breast Cancer: Comparison With CB11, Fluorescence In Situ Hybridization (FISH), and Interlaboratory Reproducibility , 2007, Applied immunohistochemistry & molecular morphology : AIMM.

[6]  F. Schmitt,et al.  HER2 evaluation using the novel rabbit monoclonal antibody SP3 and CISH in tissue microarrays of invasive breast carcinomas , 2006, Journal of Clinical Pathology.

[7]  Anthony Rhodes,et al.  American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. , 2006, Archives of pathology & laboratory medicine.

[8]  Karen A Gelmon,et al.  Immunohistochemical detection using the new rabbit monoclonal antibody SP1 of estrogen receptor in breast cancer is superior to mouse monoclonal antibody 1D5 in predicting survival. , 2006, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[9]  Zhida Huang,et al.  Development of New Rabbit Monoclonal Antibody to Progesterone Receptor (Clone SP2): No Heat Pretreatment but Effective for Paraffin Section Immunohistochemistry , 2006, Applied immunohistochemistry & molecular morphology : AIMM.

[10]  R. Siebert,et al.  FISH analysis for the detection of lymphoma-associated chromosomal abnormalities in routine paraffin-embedded tissue. , 2006, The Journal of molecular diagnostics : JMD.

[11]  M. Dowsett,et al.  Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. , 2005, The New England journal of medicine.

[12]  Greg Yothers,et al.  Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. , 2005, The New England journal of medicine.

[13]  A. D. Tos,et al.  Rabbit Monoclonal Antibodies , 2005 .

[14]  C. Vogel,et al.  Evaluation of clinical outcomes according to HER2 detection by fluorescence in situ hybridization in women with metastatic breast cancer treated with trastuzumab. , 2005, Clinical breast cancer.

[15]  A. D. Dei Tos,et al.  Rabbit monoclonal antibodies: a comparative study between a novel category of immunoreagents and the corresponding mouse monoclonal antibodies. , 2005, American journal of clinical pathology.

[16]  G. Szekeres,et al.  Development of New Rabbit Monoclonal Antibody to Estrogen Receptor: Immunohistochemical Assessment on Formalin-Fixed, Paraffin-Embedded Tissue Sections , 2005, Applied immunohistochemistry & molecular morphology : AIMM.

[17]  J. Isola,et al.  Interlaboratory Comparison of HER-2 Oncogene Amplification as Detected by Chromogenic and Fluorescence in situ Hybridization , 2004, Clinical Cancer Research.

[18]  J. Chan,et al.  Consistent Immunostaining for Cyclin D1 Can Be Achieved on a Routine Basis Using a Newly Available Rabbit Monoclonal Antibody , 2004, The American journal of surgical pathology.

[19]  L. Goldstein,et al.  HER-2 testing in breast cancer using parallel tissue-based methods. , 2004, JAMA.

[20]  D. Edwards,et al.  Comparison of different antibodies for detection of progesterone receptor in breast cancer , 2002, Steroids.

[21]  L. Bobrow,et al.  Study of interlaboratory reliability and reproducibility of estrogen and progesterone receptor assays in Europe. Documentation of poor reliability and identification of insufficient microwave antigen retrieval time as a major contributory element of unreliable assays. , 2001, American journal of clinical pathology.

[22]  D Barnes,et al.  Immunohistochemical detection of steroid receptors in breast cancer: a working protocol , 2000, Journal of clinical pathology.

[23]  C K Osborne,et al.  Estrogen receptor status by immunohistochemistry is superior to the ligand-binding assay for predicting response to adjuvant endocrine therapy in breast cancer. , 1999, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[24]  Mike Clarke,et al.  Polychemotherapy for early breast cancer: an overview of the randomised trials , 1998, The Lancet.

[25]  Mike Clarke,et al.  Tamoxifen for early breast cancer: an overview of the randomised trials , 1998, The Lancet.

[26]  B. Angus,et al.  New monoclonal antibodies to oestrogen and progesterone receptors effective for paraffin section immunohistochemistry , 1997, The Journal of pathology.

[27]  K L Knight,et al.  Rabbit monoclonal antibodies: generating a fusion partner to produce rabbit-rabbit hybridomas. , 1995, Proceedings of the National Academy of Sciences of the United States of America.

[28]  R. Cote,et al.  Antigen retrieval immunohistochemistry under the influence of pH using monoclonal antibodies. , 1995, The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society.

[29]  D. Slamon,et al.  Sensitivity of HER-2/neu antibodies in archival tissue samples: potential source of error in immunohistochemical studies of oncogene expression. , 1994, Cancer research.

[30]  W. Gullick,et al.  NCL‐CB11, a new monoclonal antibody recognizing the internal domain of the c‐erbB‐2 oncogene protein effective for use on formalin‐fixed, paraffin‐embedded tissue , 1990, The Journal of pathology.

[31]  T. Raybould,et al.  Production of stable rabbit-mouse hybridomas that secrete rabbit mAb of defined specificity. , 1988, Science.

[32]  J. Bystryn,et al.  Comparison of cell-surface human melanoma-associated antigens identified by rabbit and murine antibodies. , 1982, Hybridoma.

[33]  Jacob Cohen.  A Coefficient of Agreement for Nominal Scales , 1960 .

[34]  Dr. Kara Laing.  COMMISSION OF INQUIRY ON HORMONE RECEPTOR TESTING , 2022 .