Data Sheet
Contents
1. Management NO CDC 22 Atlanta GA April 30 1976 Decontamination of Laboratory Sink Drains to Remove Azide Salts 6 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 Table 1 Sensitivity of mouse monoclonal antibody Uroplakin II BC21 was determined by testing formalin fixed paraffin embedded neoplastic tissues Tissue Types Number Positive Number of Cases Bladder cancer 46 59 Prostate cancer 1 88 Lung cancer 0 20 Kidney cancer various phenotypes Hor Colon cancer 0 63 Brain cancer 0 13 Lymphoma 0 25 Melanoma 0 19 Ovarian cancer 0 11 Seminoma 0 14 Breast cancer 0 74 Adrenal gland cancer 0 2 Thyroid cancer 0 2 Pancreas cancer various phenotypes 0 10 Head amp neck cancer various phenotypes 0 10 Soft tissue cancer various phenotypes 0 10 Liver cancer various phenotype 0 10 Cervix cancer various phenotypes 0 10 For comparison Uroplakin II Clone AU1 stained 19 56 cases of bladder cancer positive case which may be metastatic bladder cancer that has spread to prostate 3 positive cases which are transitional cell carcinomas from upper ureters taal Biocare Medical 4040 Pike Lane Concord CA 94520 USA Tel 800 799 9499 www biocare net Table 2 Specificity of mouse monoclonal antibody Uroplakin II BC21 was determined by testing formalin fixed2. paraffin embedded normal tissues Tissue Number Positive Total Tissues Adrenal gland 0 3 Bladder 5 7 Bone marrow 0 1 Eye 0 2 Breast 0 3 Cerebellum 0 3 Cerebral cortex 0 3 Fallopian tube 0 3 GI Esophagus 0 3 GlI Stomach 0 3 Gl Small intestine 0 3 GI Colon 0 3 Gl Rectum 0 3 Heart 0 3 Kidney 0 16 Liver 0 5 Lung 0 3 Ovary 0 3 Pancreas 0 5 Parathyroid 0 1 Pituitary gland 0 2 Placenta 0 3 Prostate 0 5 Skin 0 2 Spinal cord 0 2 Spleen 0 2 Striated muscle 0 4 Testis 0 3 Thymus 0 3 Thyroid 0 4 Tonsil 0 3 Ureter 3 3 Uterus cervix 0 3 Uterus endometrium 0 3 Tongue 0 1 Epiglottis 0 1 Blood vessel and adipose tissue 0 1 EMERGO EUROPE CE Molenstraat 15 Page 2 of 2 2513 BH The Hague The Netherlands Fax 925 603 8080
3. 51 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 Uroplakin II Protocol Template Description Ms HRP Template 1 Dewaxing DS Option DS2 Antigen Retrieval AR Option AR2 low pH 101 C Reagent Name Time Temp Uroplakin II 30 min 25 C Performance Characteristics Sensitivity and specificity testing of Uroplakin II BC21 was performed by staining with MACH 4 Universal HRP Polymer Detection See Tables 1 and 2 for expected results Limitations 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
4. Uroplakin II Concentrated and Prediluted Monoclonal Antibody ISO 9001813485 CERTIFIED Control Number 901 3051 032415 Catalog Number ACI 3051 A C API 3051 AA Description 0 1 1 0 ml concentrated 6 0 ml prediluted Dilution 1 50 1 100 Ready to use Diluent Van Gogh Yellow N A Intended Use For In Vitro Diagnostic Use Uroplakin II BC21 is a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of uroplakin II 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 Uroplakin II is a 15 kDa protein component of urothelial plaques which enhance the permeability barrier of the urothelium 1 Studies have shown Uroplakin II mRNA was expressed in bladder cancer tissues and peripheral blood of patients with primary and metastatic urothelial carcinoma of the bladder 2 4 A new mouse monoclonal Uroplakin II antibody BC21 was developed and exhibited an increased staining sensitivity 46 59 78 when compared to Uroplakin III AU1 19 56 34 in cases of urothelial carcinoma of the bladder see Performance Characteristics With the exception of bladder and ureter Ur
5. 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 clsi org 2011 Precautions 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 NaN 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 EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands Fax 925 603 8080 Uroplakin II Concentrated and Prediluted Monoclonal Antibody ISO 9001813485 CERTIFIED Control Number 901 3051 032415 Precautions Cont d 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 conta
6. cting the skin and mucous membranes with reagents and specimens If reagents or specimens come in contact with sensitive areas wash with copious amounts of water 6 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 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 References 1 Wu XR et al Uroplakins in urothelial biology function and disease Kidney Int 2009 Jun 75 11 1153 65 2 Wu X et al Uroplakin II as a promising marker for molecular diagnosis of nodal metastases from bladder cancer comparison with cytokeratin 20 J Urol 2005 Dec 174 6 2138 42 3 Lu JJ et al Detection of circulating cancer cells by reverse transcription polymerase chain reaction for uroplakin I in peripheral blood of patients with urothelial cancer Clin Cancer Res 2000 Aug 6 8 3166 71 4 Li SM et al Detection of circulating uroplakin positive cells in patients with transitional cell carcinoma of the bladder J Urol 1999 Sep 162 3 Pt 1 931 S 5 Center for Disease Control Manual Guide Safety
7. e 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 Peroxide Block Block for 5 minutes with Biocare s Peroxidazed 1 Pretreatment Perform heat retrieval using Biocare s Reveal Decloaker Refer to the Reveal Decloaker product 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 taal Biocare Medical 4040 Pike Lane Concord CA 94520 USA Tel 800 799 9499 l CE Page of 2 www biocare net OAI 3051 T60 60 tests prediluted Ready to use N A Protocol Recommendations Cont d Polymer Incubate for 10 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 deionized water Apply Tacha s Bluing Solution for 1 minute Rinse with deionized water Technical Note This antibody has been standardized with Biocare s MACH 4 detection system It can also be used on an automated staining system and with other Biocare polymer detection kits Use TBS buffer for washing steps Protocol Recommendations ONCORE Automated Slide Staining System OAI30
8. oplakin II BC21 was found to be highly specific when evaluated in various normal and neoplastic tissues including prostate cancer and renal cell carcinoma see Performance Characteristics Uroplakin II BC21 is a highly specific antibody that may be useful in identifying tumors of urothelial origin PATENT PENDING 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 BC21 Isotype IgG1 kappa Total Protein Concentration 10 mg ml Call for lot specific Ig concentration Epitope Antigen Residues 36 50 of human Uroplakin I Cellular Localization Cytoplasmic and membrane Positive Tissue Control Normal bladder or urothelial carcinoma of the bladder Known Applications Immunohistochemistry 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 use after expiration date printed on vial If reagents are stored under conditions other than those specified in th
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