Data Sheet
Contents
1. 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 in contact with sensitive areas wash with copious amounts of water 3 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 Enomoto H et al Topographic distribution of Helicobacter pylori in the resected stomach Eur J Gastroenterol Hepatol 1998 Jun 10 6 473 8 2 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 3 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 The2. Hague The Netherlands
3. 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 H pylori OR H pylori AP Protocol Template Description Ms HRP Template 1 OR Ms AP Template 1 Dewaxing DS Option DS2 Antigen Retrieval AR Option AR2 low pH 101 C Reagent Name Time Temp H pylori 30 min 37 C Technical Note This antibody has been optimized for use with Biocare s MACH 4 Universal HRP Polymer Detection intelliPATH Universal HRP Detection Kit and ONCORE HRP and AP Detections 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 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 c
4. 5 60 minutes Allow solution to cool for 10 minutes then wash in distilled water Protein Block Optional Incubate for 5 10 minutes at RT with Biocare s Background Punisher Primary Antibody Incubate for 30 minutes at RT taal Biocare Medical 4040 Pike Lane Concord CA 94520 USA Page of 2 Tel 800 799 9499 l www biocare net IP 383 G10 10 ml prediluted OAI 383 T60 60 tests prediluted Ready to use N A Ready to use N A Protocol Recommendations intelliPATH and manual use Cont d 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 deionized water Apply Tacha s Bluing Solution for 1 minute Rinse with deionized water intelliPATH Automated Slide Stainer IP383 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 OAI383 is intended for use with the ONCORE Automated Slide Staining System Refer to the ONCORE Automated Slide Staining System
5. Helicobacter pylori Concentrated and Prediluted Monoclonal Antibody ISO 9001813485 CERTIFIED Control Number 901 383 032415 Catalog Number CM 383 A C PM 383 AA H L Description 0 1 1 0 ml concentrated 6 0 25 100 ml prediluted Dilution 1 100 1 200 Ready to use Diluent Renoir Red N A Intended Use For In Vitro Diagnostic Use Helicobacter pylori BC7 is a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of helicobacter pylori 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 Helicobacter pylori are spiral curved gram negative bacteria that can infect the surface epithelium of the mucous layer of the stomach There is evidence showing that these bacteria may play a significant role in peptic ulcer disease Immunohistochemical techniques can distinguish Helicobacter pylori from other types of bacterial infections This small spiral curved shaped bacterium can be clearly seen using a 100X oil objective Principle of Procedure Antigen detection in tissues and cells is a multi step immunohistochemical process The initial step binds the primary antibody
6. linical 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 clsi org 2011 EMERGO EUROPE CE Molenstraat 15 2513 BH The Hague The Netherlands Fax 925 603 8080 Helicobacter pylori ISO Concentrated and Prediluted Monoclonal Antibody ee Control Number 901 383 032415 Troubleshooting Precautions Follow the antibody specific protocol recommendations according to data sheet 1 This antibody contains less than 0 1 sodium azide Concentrations less than 0 1 provided If atypical results occur contact Buiocare s Technical Support at are not reportable hazardous materials according to U S 29 CFR 1910 1200 OSHA 1 800 542 2002 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 2
7. 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 BC7 Isotype IgGl Total Protein Concentration 10 mg ml Call for lot specific Ig concentration Epitope Antigen Helicobacter pylori Cellular Localization Spiral shaped bacterium Positive Control Stomach infected with H pylori 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 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 recommended 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 4
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