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PRAME [EPR20330] Concentrated and Prediluted Rabbit Monoclonal Antibody 901-3252-060321

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PRAME [EPR20330] Concentrated and Prediluted Rabbit Monoclonal Antibody 901-3252-060321 PRAME [EPR20330] Concentrated and Prediluted Rabbit Monoclonal Antibody 901-3252-060321 Available Product Formats Format Catalog Number Description Dilution Diluent Concentrate ACI 3252 A, B 0.1, 0.5 mL 1:100 Van Gogh Yellow Predilute API 3252 AA, H 6.0, 25 mL Ready-to-use N/A ONCORE Pro OPAI 3252 T60 60 tests Ready-to-use N/A Q Series– For Leica BOND-III ALI 3252 G7 7.0 mL Ready-to-use N/A UltraLine – For BenchMark AVI 3252 G, G25 6.0, 25mL Ready-to-use N/A Intended Use: Protocol Recommendations (intelliPATH FLX and manual use) For In Vitro Diagnostic Use Cont’d: PRAME [EPR20330] is a rabbit monoclonal antibody that is intended for Protein Block (Optional): Incubate for 5-10 minutes at RT with laboratory use in the qualitative identification of PRAME protein by Background Punisher. immunohistochemistry (IHC) in formalin-fixed paraffin-embedded (FFPE) Primary Antibody: Incubate for 30 minutes at RT. human tissues. The clinical interpretation of any staining or its absence Probe: N/A should be complemented by morphological studies using proper controls and Polymer: Incubate for 30 minutes at RT with a tertiary polymer. should be evaluated within the context of the patient’s clinical history and Chromogen: Incubate for 5 minutes at RT with Biocare’s DAB – OR – other diagnostic tests by a qualified pathologist. Incubate for 5-7 minutes at RT with Warp Red. Summary and Explanation: Counterstain: Counterstain with hematoxylin. Rinse with deionized water. PRAME (preferentially expressed antigen in melanoma) is located on Apply Tacha's Bluing Solution for 1 minute. Rinse with deionized water. chromosome 22q11.22 and encodes a 509 amino acid protein. PRAME is an Technical Note: autosomal cancer-testis antigen (CTA) gene. PRAME is expressed in This antibody, for intelliPATH FLX and manual use, has been standardized melanoma, various nonmelanocytic malignant neoplasms, including non- with MACH 4 detection system. Use TBS for washing steps. small cell lung cancer, breast carcinoma, renal cell carcinoma, ovarian carcinoma, leukemia, synovial sarcoma, and myxoid liposarcoma. Normal Protocol Recommendations (ONCORE™ Pro Automated Slide healthy tissues are not known to express PRAME except for testis, ovary, Staining System): placenta, adrenals, and endometrium. (1,2) OPAI3252 is intended for use with the ONCORE Pro. Refer to the User PRAME is one of the most widely studied CTAs and has been associated with Manual for specific instructions for use. Protocol parameters in the the outcome and risk of metastasis. PRAME is currently being investigated as Protocol Editor should be programmed as follows: a novel immunotherapy target and diagnostic marker with ongoing clinical Protocol Name: PRAME Rb trials that include Hodgkin’s disease, leukemia, multiple myeloma, breast Protocol Template (Description): Rb HRP Template 1 – OR – Rb AP cancer, pancreatic cancer, brain cancer. (3,4) Template 1 Principle of Procedure: Dewaxing (DS Buffer Option): DS Buffer Antigen detection in tissues and cells is a multi-step immunohistochemical process. The initial step binds the primary antibody to its specific epitope. Antigen Retrieval (AR Option): AR1, high pH; 103°C After labeling the antigen with a primary antibody, a one-step or two-step Block Option: Buffer detection procedure can be applied. A one-step procedure will feature an Reagent Name, Time, Temp.: PRAME Rb, 30 min., 25°C enzyme labeled polymer that binds the primary antibody. A two-step procedure will feature a linker antibody added to bind to the primary Protocol Recommendations (Ventana BenchMark ULTRA): antibody. An enzyme-labeled polymer is then added to bind the linker AVI3252 is intended for use with the BenchMark ULTRA. Refer to the User antibody. These detections of the bound antibodies are evidenced by a Manual for specific instructions for use. Recommended protocol parameters colorimetric reaction. are as follows: Source: Rabbit monoclonal Template/Detection: OptiView DAB IHC Species Reactivity: Human, others not tested Pretreatment Protocol: CC1 64 minutes Clone: EPR20330 Peroxidase: Pre Primary Peroxidase Inhibitor Isotype: IgG Primary Antibody: 32 minutes, 36°C Protein Concentration: Call for lot specific Ig concentration. Epitope/Antigen: PRAME Protocol Recommendations (Q Series – For Leica BOND-III): Cellular Localization: Nucleus and cell membrane ALI3252 is intended for use with the Leica BOND-III. Refer to the User Positive Tissue Control: Melanoma, normal testis Manual for specific instructions for use. Recommended protocol Known Applications: parameters are as follows: Immunohistochemistry (formalin-fixed paraffin-embedded tissues) Protocol Name: IHC Protocol F Supplied As: Buffer with protein carrier and preservative Detection: Bond Polymer Refine Storage and Stability: HIER: 20 min with ER2 Store at 2ºC to 8ºC. The product is stable to the expiration date printed on Peroxide Block: 5 min the label, when stored under these conditions. Do not use after expiration Marker (Primary Antibody): 15 min date. Diluted reagents should be used promptly; any remaining reagent Post Primary: 8 min should be stored at 2ºC to 8ºC. Polymer: 8 min Protocol Recommendations (intelliPATH FLX® and manual use): Mixed DAB Refine: 10 min Peroxide Block: Block for 5 minutes with Peroxidazed 1. Hematoxylin: 5 min Pretreatment: Perform heat retrieval using Borg Decloaker. Refer to the Borg Decloaker data sheet for specific instructions. Rev: 062117 PRAME [EPR20330] Concentrated and Prediluted Rabbit Monoclonal Antibody 901-3252-060321 Protocol Recommendations (Q Series – For Leica BOND-III) References Cont’d: Cont’d: 6. Clinical and Laboratory Standards Institute (CLSI). Protection of -Red Chromogen Staining Option: Laboratory Workers from Occupationally Acquired Infections; Approved Protocol Name: IHC Protocol J Guideline-Fourth Edition CLSI document M29-A4 Wayne, PA 2014. Detection: Bond Polymer Refine Red HIER: 20 min with ER2 Ultraline antibodies are developed solely by Biocare Medical LLC and do not Marker (Primary Antibody): 15 min imply approval or endorsement of Biocare antibodies by Ventana Medical Systems, Inc or Roche. Biocare, Ventana and Roche are not affiliated, Post Primary AP: 20 min associated or related in any way. Ventana®, BenchMark®, ultraView and Polymer AP: 30 min OptiView are trademarks of Roche. Mixed Red Refine: 10 min + 5 min Hematoxylin: 5 min Q Series antibodies are developed solely by Biocare Medical LLC and do not imply approval or endorsement of Biocare antibodies by Leica Biosystems. Performance Characteristics: Biocare and Leica Biosystems are not affiliated, associated or related in any Sensitivity, specificity and cross-reactivity are summarized in Tables 1 and 2, way. Leica, Leica Biosystems, BOND-MAX and BOND-III are trademarks of respectively. Leica Biosystems. Limitations: The optimum antibody dilution and protocols for a specific application can Table 1: Sensitivity and specificity were determined by testing formalin- vary. These include, but are not limited to fixation, heat-retrieval method, fixed, paraffin-embedded diseased tissues. incubation times, tissue section thickness and detection kit used. Due to the superior sensitivity of these unique reagents, the recommended incubation Positive Total Tissue times and titers listed are not applicable to other detection systems, as results Cases Cases may vary. The data sheet recommendations and protocols are based on exclusive use of Biocare products. Ultimately, it is the responsibility of the Melanoma 31 40 investigator to determine optimal conditions. Ovary Cancer 7 45 Quality Control: Breast Cancer 8 26 Refer to CLSI Quality Standards for Design and Implementation of Immunohistochemistry Assays; Approved Guideline-Second edition (I/LA28- Colon Cancer 0 36 A2) CLSI Wayne, PA USA (www.clsi.org). 2011 Lung Cancer 17 51 Precautions: Prostate Cancer 11 40 1. This antibody contains less than 0.1% sodium azide. Concentrations less Adrenocortical carcinoma 0 1 than 0.1% are not reportable hazardous materials according to U.S. 29 CFR 1910.1200, OSHA Hazard communication and EC Directive 91/155/EC. Bladder Cancer 0 2 Sodium azide (NaN3) used as a preservative is toxic if ingested. Sodium azide Meningioma 0 2 may react with lead and copper plumbing to form highly explosive metal Astrocytoma 0 1 azides. Upon disposal, flush with large volumes of water to prevent azide build-up in plumbing. (Center for Disease Control, 1976, National Institute of Squamous Cell carcinoma (esophagus) 0 2 Occupational Safety and Health, 1976) (5) Adenocarcinoma (stomach) 0 2 2. Specimens, before and after fixation, and all materials exposed to them Adenocarcinoma (small intestine) 0 1 should be handled as if capable of transmitting infection and disposed of with proper precautions. Never pipette reagents by mouth and avoid contacting Adenocarcinoma (colon & rectum) 0 6 the skin and mucous membranes with reagents and specimens. If reagents Kidney Cancer 0 2 or specimens come into contact with sensitive areas, wash with copious Liver Cancer 0 4 amounts of water. (6) 3. Microbial contamination of reagents may result in an increase in Lymphoma 3 6 nonspecific staining. Squamous Cell carcinoma (head & 0 1 4. Incubation times or temperatures other than those specified may give neck, oral cavity, tongue) erroneous results. The user must validate any such change. Nasopharyngeal carcinoma 1 1 5. Do not use reagent after the expiration date printed on the vial. 6. The SDS is available upon request and is located at http://biocare.net. Adenocarcinoma
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