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					                                                                                                                                                                        ISO
                                                                                                                                                                     9001:2000
                                                  Tumor Associated Glycoprotein [B72.3]                                                                             CERTIFIED
                                                       Concentrated and Prediluted Monoclonal Antibody
                                                                       Control Number: 901-002-091506

Catalog Number:       CM 002 A, B, C                         PM 002 AA                    Protein Block:
Description:          0.1, 0.5, 1.0 ml, concentrated         6.0 ml, prediluted           Incubate for 10-15 minutes at RT with BIOCARE's Background Sniper.

Dilution:             1:50 -1:100                            Ready-to-use                 Primary Antibody: Incubate for 30 minutes at RT.
Diluent:              Da Vinci Green                         N/A                          Link: Incubate for 10 minutes at RT with a link
                                                                                          Label: Incubate for 10 minutes at RT with a label.
Intended Use:
For In Vitro Diagnostic Use                                                               Chromogen:
Summary and Explanation:                                                                  Incubate for 5 minutes at RT when using BIOCARE's DAB. - OR - Incubate for 10
B72.3 recognizes an oncofetal antigen of >1,000kDa, identified as a tumor-associated      minutes at RT when using BIOCARE's Vulcan Fast Red.
glycoprotein (TAG-72) with properties of a mucin. The majority of human                   Technical Note:
adenocarcinomas including colorectal, pancreatic, gastric, ovarian, endometrial,          This antibody has been standardized with BIOCARE's 4 plus detection system. It can
mammary, and non-small cell lung cancer display some cell populations that are
                                                                                          also be used on an automated staining system and with other BIOCARE polymer
positive for B72.3 staining. Weak or no reactivity has been observed with most cell
types of normal adult tissue excepting the secretory endometrium. About 60% of            detection kits. Use TBS buffer for washing steps.
carcinoma patients express TAG-72 in their sera. It is reportedly useful in               Performance Characteristics:
distinguishing pulmonary adenocarcinomas that are B72.3 (+) from pleural                  The optimum antibody dilution and protocols for a specific application can vary. These
mesotheliomas that are B72.3 (-).                                                         include, but are not limited to: fixation, heat-retrieval method, incubation times, tissue
Principle of Procedure:                                                                   section thickness and detection kit used. Due to the superior sensitivity of these unique
Antigen detection, in tissues and cells, is a multi-step immunohistochemical process.     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
The initial step binds the primary antibody to its specific epitope. After labeling the
                                                                                          are based on exclusive use of BIOCARE products. Ultimately, it is the responsibility
antigen with a primary antibody, a universal, affinity-purified, secondary antibody is    of the investigator to determine optimal conditions. These products are tools that can
added to bind to the primary antibody. An enzyme label is then added to bind to the       be used for interpretation of morphological findings in conjunction with other
secondary antibody; this detection of the bound antibody is evidenced by a colorimetric   diagnostic tests and pertinent clinical data by a qualified pathologist.
reaction.
                                                                                          Quality Control:
Source: Mouse monoclonal                                                                  Refer to NCCLS Quality Assurance for Immunocytochemistry approved guidelines,
Species Reactivity: Human, mouse and rat                                                  December 1999 MM4-A Vol.19 No.26 for more information about Tissue Controls.
Clone: B72.3                                                                              Precautions:
                                                                                          This antibody contains less than 0.1% sodium azide. Concentrations less than 0.1% are
Isotype: IgG1/kappa                                                                       not reportable hazardous materials according to U.S. 29 CFR 1910.1200, OSHA
Total Protein Concentration: ~10 mg/ml. Call for lot specific Ig Concentration.           Hazard communication and EC Directive 91/155/EC.
Epitope/Antigen: TAG-72 or B72.3                                                          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
Cellular Localization: Cell surface and cytoplasmic                                       disposal, flush with large volumes of water to prevent azide build-up in plumbing.
Positive Control: Colon carcinoma or breast cancer                                        (Center for disease control, 1976, National Institute of Occupational Safety and Health,
                                                                                          1976)
Normal Tissue: Breast                                                                     Specimens, before and after fixation and all materials exposed to them, should be
Abnormal Tissue: Lung (mucinous), Breast (apocrine) and prostate carcinomas and           handled as if capable of transmitting infection and disposed of with proper precautions.
                 pancreas adenocarcinoma                                                  Never pipette reagents by mouth and avoid contacting the skin and mucous membranes
                                                                                          with reagents and specimens. If reagents or specimens come in contact with sensitive
Known Applications:                                                                       areas, wash with copious amounts of water.
Immunohistochemistry (formalin-fixed paraffin-embedded tissues)                           Microbial contamination of reagents may result in an increase in nonspecific staining.
Supplied As: Buffer with protein carrier and preservative.                                Incubation times or temperatures other than those specified may give erroneous results.
                                                                                          The user must validate any such change. The MSDS is available upon request.
Storage and Stability:
Store at 2ºC to 8ºC. Do not use after expiration date printed on vial. If reagents are    Troubleshooting:
stored under conditions other than those specified in the package insert, they must be    Follow the antibody specific protocol recommendations according to data sheet
verified by the user. Diluted reagents should be used promptly; any remaining reagent     provided. If atypical results occur, contact BIOCARE's Technical Support at
should be stored at 2ºC to 8ºC.                                                           1-800-542-2002.
                                                                                          Limitations and Warranty:
Protocol Recommendations                                                                  There are no warranties, expressed or implied, which extend beyond this description.
Peroxide Block:                                                                           BIOCARE is not liable for property damage, personal injury, or economic loss caused
If using an HRP system, block for 5 minutes with BIOCARE's PEROXIDAZED 1.                 by this product.
Pretreatment Solution (recommended): N/A                                                  References:
                                                                                          1. Van Niekerk CC, Vooijs P, Casparie-van Velsen IJ, Poels LG. Differentiation
Pretreatment Protocol: N/A                                                                margins of ovarian tumor pathology: first incidences of epithelial ovarian tumors
Digestion Method:                                                                         monitored by marker antibodies. Cancer Detect Prev 1997;21(3):247-257, 1997.
Digest with Trypsin enzyme for 5 minutes at 37ºC - or - for 15 minutes at RT.             2. Guadagni F, Roselli M et al. TAG-72 expression and its role in the biological
Avidin-Biotin Block is recommended:                                                       evaluation of human colorectal cancer. Anticancer Res, Jul;16(4B):2141-2148, 1996.
1. Apply Avidin solution for 10 minutes and wash with TBS wash buffer.                    3. Center for Disease Control Manual. Guide: Safety Management, NO. CDC-22,
2. Apply Biotin solution for 10 minutes and wash with TBS wash buffer.                    Atlanta, GA. April 30, 1976 "Decontamination of Laboratory Sink Drains to Remove
                                                                                          Azide Salts."
                                                                                          4. National Committee for Clinical Laboratory Standards(NCCLS). Protection of
                                                                                          laboratory workers from infectious diseases transmitted by blood and tissue; proposed
                                                                                          guideline. Villanova, PA 1991;7(9). Order code M29-P.




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