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Do not freeze.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Content", "Value": "CONFIRM anti-PSA antibody contains sufficient reagent for staining 50 slides.

One 5 mL dispenser of CONFIRM anti-PSA antibody contains approximately 3.5 μg of a rabbit polyclonal antibody.
The antibody is diluted in 0.05 M Tris-HCI with 2% carrier protein, and 0.10% ProClin 300, a preservative.
Total protein concentration of the reagent is approximately 11 μg/mL.
Specific antibody concentration is approximately 0.7 μg/mL. There is no known non-specific antibody reactivity observed in this product.
There is a trace (~0.5%) of bovine serum albumin of U.S. origin from the stock solution. Refer to the appropriate VENTANA detection kit methodsheet 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" }, { "Name": "Intended Use", "Value": "Le CONFIRM anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Primary Antibody est destiné à être utilisé en laboratoire pour la détection immunohistochimique qualitative par microscopie optique du PSA dans des coupes de tissus fixés au formol et inclus en paraffine colorées sur un appareil BenchMark IHC/ISH.

Ce produit doit être interprété par un anatomopathologiste qualifié, en complément d’examens histologiques, d’informations cliniques pertinentes et de contrôles adaptés.

Cet anticorps est conçu pour une utilisation en diagnostic in vitro (IVD).", "Language": "fr", "Country": "XG", "Code": "Intended Use" }, { "Name": "Background Information", "Value": "CONFIRM anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Primary Antibody (CONFIRM anti-PSA antibody) is a polyclonal antibody produced against the human PSA protein. PSA is a 34 kD chymotrypsin-like serine protease that functions to liquefy the seminal fluid coagulum, thus helping in the release of spermatozoa.1 In addition to being expressed in normal prostate epithelium, hyperplastic and malignant prostate tissues also express PSA.1

For metastatic tumors that do not readily present with a clinically known or suspected primary site, a series of organ or lineage-specific IHC studies may be used to aid in determining origin.2 In this context, detection of PSA by IHC is widely used by pathologists to determine prostatic origin.1,2,3 PSA positive IHC staining is observed in high percentages of lymph node metastases and distant metastases of prostate cancer samples.4,5 PSA is also the only biomarker recommended by the European Society for Medical Oncology (ESMO) guidelines to show prostatic origin of a metastatic lesion.6 Thus, IHC detection of PSA with CONFIRM anti-PSA antibody may be used as an aid in the identification of adenocarcinoma of the prostate in metastatic sites.

PSA is considered an established IHC marker to aid in distinguishing between prostate carcinoma (PSA+) and urothelial carcinoma (PSA-). This association is based on numerous studies from as early as 2000 that demonstrate PSA to be highly sensitive and specific for prostate carcinoma versus urothelial carcinoma.3,7,8,9,10 Thus, IHC detection of PSA with CONFIRM anti-PSA antibody may be used to aid in the differentiation between prostate adenocarcinoma from urothelial carcinoma.

The staining pattern for this antibody is cytoplasmic. It may be used as part of a panel of IHC studies.

1. Dabbs DJ. Diagnostic Immunohistochemistry: Theranostic and Genomic Applications. Elsevier; 2018.
2. Krishna M. Diagnosis of Metastatic Neoplasms: An Immunohistochemical Approach. Arch Pathol Lab Med. 2010;134(2):207-215..
3. Chuang AY, DeMarzo AM, Veltri RW, et al. Immunohistochemical Differentiation of High-Grade Prostate Carcinoma from Urothelial Carcinoma. Am J Surg Pathol. 2007;31(8):1246-1255.
4. Queisser A, Hagedorn SA, Braun M, et al. Comparison of Different Prostatic Markers in Lymph Node and Distant Metastases of Prostate Cancer. Modern Pathology. 2014;28(1):138-145.
5. Sheridan T, Herawi M, Epstein JI, et al. The Role of P501s and Psa in the Diagnosis of Metastatic Adenocarcinoma of the Prostate. Am J Surg Pathol. 2007;31(9):1351- 1355.
6. Fizazi K, Greco FA, Pavlidis N, et al. Cancers of Unknown Primary Site: Esmo Clinical Practice Guidelines for Diagnosis, Treatment and Follow-Up. Annals of Oncology. 2015;26(suppl 5):v133-v138.
7. Genega EM, Hutchinson B, Reuter VE, et al. Immunophenotype of High-Grade Prostatic Adenocarcinoma and Urothelial Carcinoma. Modern Pathology. 2000;13(11):1186-1191.
8. Kunju LP, Mehra R, Snyder M, et al. Prostate-Specific Antigen, High-Molecular- Weight Cytokeratin (Clone 34βe12), and/or P63. Am J Clin Pathol. 2006;125(5):675- 681.
9. Mhawech P, Uchida T, Pelte M-F. Immunohistochemical Profile of High-Grade Urothelial Bladder Carcinoma and Prostate Adenocarcinoma. Hum Pathol. 2002;33(11):1136-1140.
10. Oh WJ, Chung AM, Kim JS, et al. Differential Immunohistochemical Profiles for Distinguishing Prostate Carcinoma and Urothelial Carcinoma. J Pathol Transl Med. 2016;50(5):345-354.", "Language": "en", "Country": "XG", "Code": "Background Information" }, { "Name": "Principle", "Value": "CONFIRM anti-PSA antibody binds to free and bound human PSA in formalin-fixed, paraffin-embedded (FFPE) tissues. This antibody can be visualized using ultraView Universal DAB Detection Kit (Cat. No. 760-500 / 05269806001) and OptiView DAB IHC Detection Kit (Cat. No. 760-700 / 06396500001). Refer to the respective method sheet for further information.", "Language": "en", "Country": "XG", "Code": "Principle" }, { "Name": "Product Purpose", "Value": "Le CONFIRM anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Primary Antibody est destiné à être utilisé en laboratoire pour la détection immunohistochimique qualitative par microscopie optique du PSA dans des coupes de tissus fixés au formol et inclus en paraffine colorées sur un appareil BenchMark IHC/ISH.

Ce produit doit être interprété par un anatomopathologiste qualifié, en complément d’examens histologiques, d’informations cliniques pertinentes et de contrôles adaptés.

Cet anticorps est conçu pour une utilisation en diagnostic in vitro (IVD).", "Language": "fr", "Country": "XG", "Code": "Product Purpose" } ] } } ] }

CONFIRM anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Primary Antibody

IVD For in vitro diagnostic use.
CONFIRM anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Primary Antibody

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