Data Sheet
Contents
1. erythroid lineages in the human fetal and embryonic liver is rare In a study of 50 archived T cell lymphomas UCHL 1 a monoclonal antibody to CD45RO showed reactivity with 94 of cases but lacked absolute specificity for T cells especially in high grade lymphomas CD3 showed reactivity with 80 of neoplastic cells but with a higher specificity 1 When used in conjunction UCHL 1 and monoclonal CD3 identified the majority of T cell lymphomas in paraffin sections 2 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 A secondary antibody may be applied to bind the primary antibody followed by an enzyme labeled polymer or an enzyme labeled polymer may be applied directly to bind the primary antibody The detection of the bound primary antibody is evidenced by an enzyme mediated colorimetric reaction Source Mouse monoclonal Species Reactivity Human others not tested Clone PS1 Isotype IgG2a Total Protein Concentration 10 mg ml Call for lot specific Ig concentration Epitope Antigen CD3 Cellular Localization Predominantly cell membrane Some cytoplasmic Positive Tissue Control Tonsil or T cell lymphoma Known Applications Immunohistochemstry formalin fixed paraffin embedded tissues Supplied As Buffer with protein carrier and preservative Storage and Stability Store at 2 C to 8 C Do not u2. 24 2 Steward M et al Production and characterization of a new monoclonal antibody effective in recognizing the CD3 T cell associated antigen in formalin fixed embedded issue Histopathology 1997 Jan 30 1 16 22 3 Center for Disease Control Manual Guide Safety Management NO CDC 22 Atlanta GA April 30 1976 Decontamination of Laboratory Sink Drains to Remove Azide Salts 4 Clinical and Laboratory Standards Institute CLSI Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Fourth Edition CLSI document M29 A4 Wayne PA 2014 aol Biocare Medical 4040 Pike Lane CE Concord CA 94520 Page 2 of 2 USA Tel 800 799 9499 www biocare net Fax 925 603 8080 EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands
3. CD3 T Cell M Concentrated and Prediluted Monoclonal Antibody ISO 9001813485 CERTIFIED Control Number 901 110 032415 Catalog Number CM 110 AK BK CK PM 110 AA H Description 0 1 0 5 1 0 ml concentrated 6 0 25 ml prediluted Dilution 1 50 1 100 Ready to use Diluent Renoir Red N A Intended Use For In Vitro Diagnostic Use CD3 T Cell M PS1 is a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of CD3 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 Monoclonal antibody to human CD3 when used in conjunction with other antibodies is regarded as a reliable pan T cell antibody used in the immunophenotyping of lymphomas in paraffin sections Most T cell lymphomas show positivity for CD3 Notable exceptions include some of the more aggressive large T cell lymphomas and anaplastic large cell Ki 1 CD30 lymphomas which may not express detectable antigen CD3 immunoreactivity has also been reported in a minority of Reed Sternberg cells of Hodgkin s disease and in some histiocytic tumors CD3 expression of hemapoietic cells of the lymphoid myeloid and
4. d EC Directive 91 155 EC Sodium azide NaN used as a preservative is toxic if ingested Sodium azide may react with lead and copper Troubleshooting Follow the antibody specific protocol recommendations according to data sheet provided If atypical results occur contact Buiocare s Technical Support at 1 800 542 2002 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 3 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 contact with sensitive areas wash with copious amounts of water 4 3 Microbial contamination of reagents may result in an increase in nonspecific staining 4 Incubation times or temperatures other than those specified may give erroneous results The user must validate any such change 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 References 1 Cabecadas JM Isaacson PG Phenotyping of T cell lymphomas in paraffin sections which antibodies Histopathology 1991 Nov 19 5 419
5. 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 Quality Control Refer to CLSI Quality Standards for Design and Implementation of Immunohistochemistry Assays Approved Guideline Second edition I LA28 A2 CLSI Wayne PA USA www clsiorg 2011 EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands Fax 925 603 8080 CD3 T Cell M Concentrated and Prediluted Monoclonal Antibody Control Number 901 110 032415 Precautions ISO 9001813485 CERTIFIED 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 an
6. nized water Apply Tacha s Bluing Solution for 1 minute Rinse with deionized water Technical Note This antibody has been optimized for use with Biocare s MACH 4 Universal HRP Polymer Detection and intelliPATH Universal HRP Detection Kit Other Biocare polymer detection kits may be used however users must validate incubation times and protocols for their specific application Use TBS for washing steps intelliPATH Automated Slide Stainer IP110 is intended for use on the intelliPATH Automated Slide Stainer Refer to the intelliPATH Automated Slide Stainer manual for specific instructions on its use When using the intelliPATH peroxide block with intelliPATH Peroxidase Blocking Reagent IPB5000 may be performed following heat retrieval Protocol Recommendations ONCORE Automated Slide Staining System OAI110 is intended for use with the ONCORE Automated Slide Staining System Refer to the ONCORE Automated Slide Staining System User Manual for specific instructions on its use Protocol parameters in the ONCORE Automated Slide Stainer Protocol Editor should be programmed as follows Protocol Name CD3 Protocol Template Description Ms HRP Template 1 Dewaxing DS Option DS2 Antigen Retrieval AR Option AR1 high pH 101 C Reagent Name Time Temp CD3 30 min 25 C Limitations The optimum antibody dilution and protocols for a specific application can vary These include but are not limited to fixation heat retrieval
7. se 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 2 C to 8 C Protocol Recommendations intelliPA TH and manual use Peroxide Block Block for 5 minutes with Biocare s Peroxidazed 1 Pretreatment Solution Borg or Reveal Pretreatment Protocol Heat Retrieval Method Retrieve sections under pressure using Biocare s Decloaking Chamber followed by a wash in distilled water alternatively steam tissue sections for 45 60 minutes Allow solution to cool for 10 minutes then wash in distilled water taal Biocare Medical 4040 Pike Lane Concord CA 94520 USA Tel 800 799 9499 l CE Page of 2 www biocare net IP 110 G10 10 ml prediluted OAI 110 T60 60 tests prediluted Ready to use N A Ready to use N A Protocol Recommendations intelliPATH and manual use Cont d Protein Block Optional Incubate for 5 10 minutes at RT with Biocare s Background Punisher Primary Antibody Incubate for 30 45 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 Chromogen Incubate for 5 minutes at RT with Biocare s DAB OR Incubate for 5 7 minutes at RT with Biocare s Warp Red Counterstain Counterstain with hematoxylin Rinse with deio
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