Gyártó: Biocare Medical
Catalog Number: ACI 3184 A, C API3184 AA « vissza
Description: 0.1, 1.0 ml, 6.0 ml, prediluted
Dilution: 1:100 Ready-to-use
Diluent: Van Gogh Yellow N/A
IVD - CE
For In Vitro Diagnostic Use
CDX2 [BC39] is a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of CDX2 protein by immunohistochemistry (IHC) in formalin-fixed paraffin-embedded (FFPE) human tissues. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist.
Summary and Explanation:
CDX2 is a homeobox gene that encodes an intestine-specific transcription factor and is expressed in the nuclei of epithelial cells of the intestine, from duodenum to rectum. The CDX2 protein is expressed in primary and metastatic colorectal carcinomas (1,2). It has also been identified in primary ovarian mucinous tumors and metastatic mucinous carcinomas involving the ovary (3). Studies have shown that the CDX2 marker is a more specific and sensitive marker when compared to CK20 (4). According to in-house studies, CDX2 [BC39] showed equal or superior sensitivity to clone CDX2-88, with virtually identical specificity.
Principle of Procedure:
Antigen detection in tissues and cells is a multi-step immunohistochemical process. The initial step binds the primary antibody to its specific epitope. After labeling the antigen with a primary antibody, a secondary antibody is added to bind to the primary antibody. An enzyme label is then added to bind to the secondary antibody; this detection of the bound antibody is evidenced by a colorimetric reaction.
Source: Mouse monoclonal
Species Reactivity: Human; others not tested
Total Protein Concentration: ~10 mg/ml. Call for lot specific Ig concentration.
Immunogen: Human CDX2 recombinant protein (aa106-305)
Cellular Localization: Nuclear
Positive Tissue Control: Colon cancer
Immunohistochemistry (formalin-fixed paraffin-embedded tissues)
Supplied As: Buffer with protein carrier and preservative
Storage and Stability:
Store at 2ºC to 8ºC. Do not use after expiration date printed on vial. If reagents are stored under conditions other than those specified in the package insert, they must be verified by the user. Diluted reagents should be used promptly; any remaining reagent should be stored at 2ºC to 8ºC.
Peroxide Block: Block for 5 minutes with Biocare's Peroxidazed 1.
Pretreatment: Perform heat retrieval using Biocare’s Diva Decloaker. Refer to the Diva Decloaker data sheet for specific instructions.
Protein Block (Optional): Incubate for 5-10 minutes at RT with Biocare's Background Punisher.
Primary Antibody: Incubate for 30 minutes at RT.
Probe: Incubate for 10 minutes at RT with a secondary probe.
Polymer: Incubate for 10-20 minutes at RT with a tertiary polymer.
Incubate for 5 minutes at RT with Biocare’s DAB – OR – Incubate for 5-7 minutes at RT with Biocare’s Warp Red.
Counterstain with hematoxylin. Rinse with deionized water. Apply Tacha's Bluing Solution for 1 minute. Rinse with deionized water.
This antibody has been standardized with Biocare's MACH 4 detection system. Use TBS buffer for washing steps.
Sensitivity and specificity on diseased and normal tissues are summarized in Tables 1 and 2, respectively.
The optimum antibody dilution and protocols for a specific application can vary. These include, but are not limited to fixation, heat-retrieval method, incubation times, tissue section thickness and detection kit used. Due to the superior sensitivity of these unique reagents, the recommended incubation times and titers listed are not applicable to other detection systems, as results may vary. The data sheet recommendations and protocols are based on exclusive use of Biocare products. Ultimately, it is the responsibility of the investigator to determine optimal conditions. The clinical interpretation of any positive or negative staining should be evaluated within the context of clinical presentation, morphology and other histopathological criteria by a qualified pathologist. The clinical interpretation of any positive or negative staining should be complemented by morphological studies using proper positive and negative internal and external controls as well as other diagnostic tests.
Refer to CLSI Quality Standards for Design and Implementation of Immunohistochemistry Assays; Approved Guideline-Second edition (I/LA28-A2) CLSI Wayne, PA USA (www.clsi.org). 2011
1. This antibody contains less than 0.1% sodium azide. Concentrations less 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. Sodium azide (NaN3) used as a preservative is toxic if ingested. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. Upon disposal, flush with large volumes of water to prevent azide build-up in plumbing. (Center for Disease Control, 1976, National Institute of Occupational Safety and Health, 1976) (5)
2. Specimens, before and after fixation, and all materials exposed to them should be handled as if capable of transmitting infection and disposed of with proper precautions. Never pipette reagents by mouth and avoid contacting the skin and mucous membranes with reagents and specimens. If reagents or specimens come into