{ "ProductData": { "ID": "RTD001100", "ProductType": "Others", "BrandName": "PSA (ER-PR8) Mouse Monoclonal Antibody", "ProductNameAddition": "IVD", "RegulatoryDisclaimer1": "For in vitro diagnostic use.", "DisclaimerGroup1": "IVD", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ "Formalin-Fixed Paraffin-Embedded Tissue (FFPET)" ], "LicenseDisclaimers": [ ], "RelatedLinks": "Cell Marque - Instructions for Use
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"StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "080", "StructureNodeStatus": "Active", "NodeName": "BenchMark" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "05269334001", "MaterialDescription": "Cell Marque, PSA (ER-PR8)", "RegisteredProductName": "PSA (ER-PR8)", "GTIN": "00841683100591", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "760-4271", "PackSizePIM360": "50 tests", "PackSizeDescPIM360": "Not Available", "MaterialAnnotation": "", "ReadyForUse": "true", "OrderInformation": "" } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "INS_2099", "BrandName": "BenchMark ULTRA", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "2300", "StructureGroupPath": "Histology->Systems / Digital Products->Advanced Staining->BenchMark ULTRA", "StructureGroupName": "BenchMark ULTRA", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "080", "StructureGroupPath": "BenchMark", "StructureGroupName": "BenchMark", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "080-00", "StructureGroupPath": "Pathology Lab", "StructureGroupName": "Pathology Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "010", "StructureGroupPath": "Histopathology", "StructureGroupName": "Histopathology", 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Do not freeze.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Content", "Value": "One dispenser of the stated primary antibody (760-4271) contains sufficient prediluted reagent for 50 tests. The antibody is diluted in Tris Buffer, pH 7.3-7.7, with 1% BSA and <0.1% Sodium Azide.", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Background Information", "Value": "Prostate-Specific Antigen (PSA) is a 33 kDa protein primarily produced by the prostatic epithelium and the epithelial lining of the periurethral glands¹. PSA is strongly expressed in both normal and neoplastic prostatic tissue. Although PSA can be considered prostate-specific, PSA and/or PSA gene expression has been detected at low levels in some extra-prostatic tissues such as normal breast tissue, breast tumors, endometrium, adrenal neoplasms and renal cell carcinomas^1,2,3. Anti- PSA is most useful in determining the prostatic origin of carcinomas in non-prostate tissues (metastatic disease) using IHC techniques. This product is best used in conjunction with a panel of antibodies as, up to 27% of prostate carcinoma cases (predominantly poorly differentiated carcinomas) can be negative for this marker.⁴

1. Polascik, TJ et al. Prostate specific antigen: a decade of discovery – what we have learned and where we are going. J Urol 1999; 162:293.
2. Stenman, U-H et al. Prostate-specific antigen. Cancer Biol 1999; 9:83- 93.
3. Alanen, KA et al. Immunohistochemical labelling for prostate specific antigen in non prostatic tissues. Path Res Pract 1996; 192:233-237.
4. Varma, M & Jasani, B. Diagnostic utility of immunohistochemistry in morphologically difficult prostate cancer: review of current literature. Histopathology 2005; 47:1-16.", "Language": "en", "Country": "XG", "Code": "Background Information" }, { "Name": "Intended Use", "Value": "This antibody is intended for in vitro diagnostic (IVD) use.

The Cell Marque PSA (ER-PR8) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods. Use of this antibody is indicated, subsequent to clinical differential diagnosis, as an aid in the identification of prostatic adenocarcinoma within the context of an antibody panel, the patient’s clinical history, and other diagnostic tests evaluated by a qualified pathologist.", "Language": "en", "Country": "XG", "Code": "Intended Use" }, { "Name": "Principle", "Value": "The stated primary antibody (760-4271) may be used as the primary antibody for immunohistochemical staining of formalin-fixed, paraffinembedded tissue sections. In general, immunohistochemical staining in conjunction with a streptavidin-biotin detection system allows the visualization of antigens via the sequential application of a specific antibody (primary antibody) to the antigen, a secondary antibody (link antibody) to the primary antibody, an enzyme complex and a chromogenic substrate with interposed washing steps. Alternatively, a biotin-free detection system may be used. The enzymatic activation of the chromogen results in a visible reaction product at the antigen site. The specimen may then be counterstained and a coverslip applied. Results are interpreted using a light microscope and aid in the differential diagnosis of pathophysiological processes, which may or may not be associated with a particular antigen.

The stated primary antibody (760-4271) is optimally diluted to be compatible with Ventana Roche detection kits and automated slide stainers. Each step in the staining protocol includes incubation for a precise time at a specific temperature. At the end of each incubation step, the sections are rinsed by the Ventana Roche automated slide stainer to stop the reaction and remove unbound material that would hinder the desired reaction in subsequent steps. To minimize evaporation of the aqueous reagents from the specimen-containing slide, a coverslip solution is applied in the slide stainer. For more detailed information on instrument operation, refer to the appropriate Ventana Roche automated slide stainer Operator’s Manual.", "Language": "en", "Country": "XG", "Code": "Principle" }, { "Name": "Product Purpose", "Value": "This antibody is intended for in vitro diagnostic (IVD) use.

The Cell Marque PSA (ER-PR8) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods. Use of this antibody is indicated, subsequent to clinical differential diagnosis, as an aid in the identification of prostatic adenocarcinoma within the context of an antibody panel, the patient’s clinical history, and other diagnostic tests evaluated by a qualified pathologist.", "Language": "en", "Country": "XG", "Code": "Product Purpose" } ] } } ] }