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"Chapters": [
{
"Name": "Storage Conditions (Product)",
"Value": "Upon receipt and when not in use, store at 2-8°C.",
"Language": "en",
"Country": "XG",
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{
"Name": "Intended Use",
"Value": "CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody (CONFIRM anti-ER (SP1) antibody) is intended for laboratory use in the qualitative detection of estrogen receptor (ER) antigen in sections of formalin-fixed, paraffin-embedded breast tissue on a VENTANA automated slide stainer with VENTANA detection kits and ancillary reagents. CONFIRM anti-ER (SP1) antibody is directed against an epitope present on human ER alpha protein located in the nucleus of ER positive normal and neoplastic cells. CONFIRM anti-ER (SP1) antibody is indicated as an aid in the management, prognosis, and prediction of hormone therapy for breast carcinoma.
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
Prescription use only.
This antibody is intended for in vitro diagnostic (IVD) use.",
"Language": "en",
"Country": "XG",
"Code": "Intended Use"
},
{
"Name": "Principle",
"Value": "CONFIRM anti-ER (SP1) antibody binds to ER in formalin-fixed, paraffin-embedded (FFPE) tissue sections. The specific antibody can be localized by either a biotin conjugated secondary antibody formulation that recognizes rabbit immunoglobulins, followed by the addition of a streptavidin horseradish peroxidase (HRP) conjugate (iVIEW DAB Detection Kit) or a secondary antibody-HRP conjugate (ultraView Universal DAB Detection Kit). The specific antibody-enzyme complex is then visualized with a precipitating enzyme reaction product. Clinical cases should be evaluated within the context of the performance of appropriate controls. Ventana recommends the inclusion of a positive tissue control fixed and processed in the same manner as the patient specimen (for example, a weakly positive breast carcinoma or uterus). In addition to staining with CONFIRM anti-ER (SP1) antibody, a second slide should be stained with CONFIRM Negative Control Rabbit Ig. For the test to be considered valid, the positive control tissue should exhibit nuclear staining of the tumor cells or uterine glands and stroma. These components should be negative when stained with CONFIRM Negative Control Rabbit Ig. In addition, it is recommended that a negative tissue control slide (for example, an ER negative breast carcinoma) be included for every batch of samples processed and run on a BenchMark IHC/ISH instrument. This negative tissue control should be stained with CONFIRM anti-ER (SP1) antibody to ensure that the antigen enhancement and other pretreatment procedures did not create false positive staining.",
"Language": "en",
"Country": "XG",
"Code": "Principle"
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{
"Name": "Content",
"Value": "CONFIRM anti-ER (SP1) antibody (Cat. No. 790-4324) contains sufficient reagent for 50 tests.
One 5 mL dispenser of CONFIRM anti-ER (SP1) antibody contains approximately 5 μg of a rabbit monoclonal antibody directed against human ER antigen.
CONFIRM anti-ER (SP1) antibody (Cat. No. 790-4325) contains sufficient reagent for 250 tests.
One 25 mL dispenser CONFIRM anti-ER (SP1) antibody contains approximately 25 μg of a rabbit monoclonal antibody directed against human ER antigen.
The antibody is diluted in Tris-HCl with carrier protein, and 0.10% ProClin 300, a preservative. There is trace (~0.2%) fetal calf serum of United States origin from the stock solution.
Specific antibody concentration is approximately 1 μg/mL. There is no known non-specific antibody reactivity in this product.
CONFIRM anti-ER (SP1) antibody is a rabbit monoclonal antibody produced as a cell culture supernatant.
Refer to the appropriate VENTANA detection kit method sheet for detailed descriptions of: Principle of the Procedure, Material and Methods, Specimen Collection and Preparation for Analysis, Quality Control Procedures, Troubleshooting, Interpretation of Results, and Limitations.",
"Language": "en",
"Country": "XG",
"Code": "Content"
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{
"Name": "Background Information",
"Value": "CONFIRM anti-ER (SP1) antibody is a rabbit monoclonal antibody that recognizes human estrogen receptor (ER) alpha. ER is a nuclear hormone receptor encoded by two distinct genes, ESR1 and ESR2, that transcribe alpha and beta isoforms respectively.1,2 ER alpha is the primary isoform expressed in luminal epithelial cells in breast tissue.1,2 ER activity drives normal mammary gland development and is required for differentiation and proliferation in the adult breast epithelium.3,4 In neoplastic cells upregulated ER activity, induced by overexpression of the receptor, initiates a cascade of cellular events that result in hyper proliferation and tumor formation.5
Breast cancer is the leading cause of cancer related death in women.6 The diagnosis and treatment of the disease relies on early detection coupled with an appropriate treatment strategy based on prognostic and predictive factors.7,8 ER was identified as a prognostic indicator in breast cancer in 1973 and its value in predicting response to endocrine therapy was evaluated in a large cohort in 1986.9,10 ER has since become one of the paradigm tumor markers for the management of patients with breast cancer. A high ER concentration on the mammary tumor correlates with greater response to endocrine therapy.7,8 The knowledge of ER status plays an important role in the selection of treatment for the patient but is not the sole basis for treatment selection.7,8 It has been shown in a number of studies that the presence of ER confers a favorable long term prognosis.10,11
Clinical guidelines and best practice recommendations stipulate that ER status should be evaluated in every case of primary invasive breast cancer to identify patients most likely to respond to endocrine forms of therapy.7,8 Selective estrogen receptor modulators block estrogen mediated cancer growth by mitigating ER hyperactivity and are used as endocrine (hormone) therapy for patients overexpressing the receptor.8,12 Currently, the treatment of choice for ER positive carcinomas is tamoxifen.7,8
Guidelines and best practice recommendations emphasize that immunohistochemistry (IHC) is the preferred method to detect ER in breast cancer.13 Studies of large cohorts of invasive breast cancer cases conclude that anti-ER clone SP1 is more sensitive for ER detection than mouse monoclonal clones 1D5 and 6F11.14,15 The IHC-based detection of ER with CONFIRM anti-ER (SP1) antibody may be used as an aid in the management, prognosis and prediction of hormone therapy for breast carcinoma.
1. Paterni I, Granchi C, Katzenellenbogen JA, et al. Estrogen receptors alpha (ERalpha) and beta (ERbeta): subtype-selective ligands and clinical potential. Steroids. 2014;90:13-29.
2. Yasar P, Ayaz G, User SD, et al. Molecular mechanism of estrogen-estrogen receptor signaling. Reprod Med Biol. 2017;16(1):4-20.
3. Tanos T, Rojo L, Echeverria P, et al. ER and PR signaling nodes during mammary gland development. Breast Cancer Res. 2012;14(4):210.
4. Diep CH, Ahrendt H, Lange CA. Progesterone induces progesterone receptor gene (PGR) expression via rapid activation of protein kinase pathways required for cooperative estrogen receptor alpha (ER) and progesterone receptor (PR) genomic action at ER/PR target genes. Steroids. 2016;114:48-58.
5. Carroll JS. Mechanisms of oestrogen receptor (ER) gene regulation in breast cancer. Eur J Endocrinol. 2016;175(1):R41-49.
6. Torre LA, Islami F, Siegel RL, et al. Global Cancer in Women: Burden and Trends. Cancer Epidemiol Biomarkers Prev. 2017;26(4):444-457.
7. Cardoso F, Kyriakides S, Ohno S, et al. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019.
8. Goldhirsch A, Winer EP, Coates AS, et al. Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2013. Ann Oncol. 2013;24(9):2206-2223.
9. McGuire WL. Estrogen receptors in human breast cancer. J Clin Invest. 1973;52(1):73-77.
10. Vollenweider-Zerargui L, Barrelet L, Wong Y, et al. The predictive value of estrogen and progesterone receptors' concentrations on the clinical behavior of breast cancer in women. Clinical correlation on 547 patients. Cancer. 1986;57(6):1171-1180.
11. Cheang MC, Treaba DO, Speers CH, 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. JCO. 2006;24(36):5637-5644.
12. Swaby RF, Sharma CG, Jordan VC. SERMs for the treatment and prevention of breast cancer. Rev Endocr Metab Disord. 2007;8(3):229-239.
13. Hammond ME, Hayes DF, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. Arch Pathol Lab Med. 2010;134(6):907-22.
14. Bae YK, Gong G, Kang J, et al. Hormone Receptor Expression in Invasive Breast Cancer Among Korean Women and Comparison of 3 Antiestrogen Receptor Antibodies - A Multi-institutional Retrospective Study Using Tissue Microarrays. Am J Surg Pathol 2012;36:1817–1825.
15. Bogina G, Zamboni G, Sapino A, et al. Comparison of Anti-Estrogen Receptor Antibodies Sp1, 6f11, and 1d5 in Breast Cancer: Lower 1d5 Sensitivity but Questionable Clinical Implications. Am J Clin Pathol. 2012;138(5):697-702.",
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"Value": "CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody (CONFIRM anti-ER (SP1) antibody) is intended for laboratory use in the qualitative detection of estrogen receptor (ER) antigen in sections of formalin-fixed, paraffin-embedded breast tissue on a VENTANA automated slide stainer with VENTANA detection kits and ancillary reagents. CONFIRM anti-ER (SP1) antibody is directed against an epitope present on human ER alpha protein located in the nucleus of ER positive normal and neoplastic cells. CONFIRM anti-ER (SP1) antibody is indicated as an aid in the management, prognosis, and prediction of hormone therapy for breast carcinoma.
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
Prescription use only.
This antibody is intended for in vitro diagnostic (IVD) use.",
"Language": "en",
"Country": "XG",
"Code": "Product Purpose"
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