RISHzymeTM for ONCORE
Contents
1. Troubleshooting Follow the reagent specific protocol recommendations according to the data sheet provided If atypical results occur contact Biocare s Technical Support at 1 800 542 2002 References 1 Wilkinson DG In Situ Hybridization A Practical Approach Practical Approach Series 2nd Ed Oxford Oxford University Press 1999 2 Nuovo GJ In Situ Molecular Pathology and Co Expression Analyses Ist Ed San Diego Academic Press 2013 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 EMERGO EUROPE Molenstraat 15 2513 BH The Hague The Netherlands Fax 925 603 80802. ANNICA WING Z RISHzyme for ONCORE Enzyme Pretreatment Reagent for n situ Hybridization BIOCARE M E D C A L ISO 9001 amp 13485 CERTIFIED Procedures on the ONCORE Automated Slide Stainer Control Number 901 6039K 012715 Catalog Number ORI6039K T120 Description 120 tests Intended Use For In Vitro Diagnostic Use RISHzyme for ONCORE is a buffered digestive enzyme solution intended for use in pretreatment of formalin fixed paraffin embedded FFPE tissues in an in situ hybridization ISH procedure performed on Biocare Medical s ONCORE Automated Slide Stainer The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient s clinical history and other diagnostic tests by a qualified pathologist Summary amp Explanation RISHzyme for ONCORE is a digestive enzyme used in the pretreatment of formalin fixed paraffin embedded tissues FFPE to enhance probe accessibility to nucleic acid targets In FFPE tissues certain in situ hybridization protocols require enzymatic pretreatment for proper ISH staining RISHzyme is an aggressive enzyme and can be used at room temperature or at 37 C Certain tissues require this type of aggressive enzyme digestion prior to heat retrieval for optimal results When used in combination with RISH Retrieval for ONCORE a synergistic effect on probe accessibi
3. ical 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 Precautions 1 This product is intended for in vitro diagnostic IVD use 2 This product is classified as non hazardous based on the concentrations and hazards of the components in compliance with the Globally Harmonized System of Classification and Labeling of Chemicals GHS the US OSHA Hazard Communication Standard HCS and European Union Classification Labeling and Packaging CLP regulations 3 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 Avoid contacting the skin and mucous membranes with reagents and specimens and follow standard laboratory precautions to prevent exposure to eyes and skin If reagents or specimens come in contact with sensitive areas wash with copious amounts of water 3 4 Microbial contamination of reagents may result in an increase in nonspecific staining 5 The SDS is available upon request and is located at http biocare net
4. lity to nucleic acid targets may be achieved This product is provided as a two component system and may be prepared at various concentrations as desired by the user Known Applications in situ hybridization FFPE tissues Supplied As RISHzyme for ONCORE is supplied as two solutions concentrated enzyme and buffer with preservative intended to be mixed prior to use RISHzyme ORI6022 G3 3 mL RISHzyme Buffer ORI6023 T30 30 tests 4 vials x 6 7 mL Reconstitution Dilution and Mixing RISHzyme for ONCORE is provided as an enzyme concentrate with buffer for dilution Add 7 drops of RISHzyme to 1 buffer vial for a 1 25 dilution Add 3 4 drops of RISHzyme to 1 buffer vial for an approximate 1 50 dilution RISHzyme Buffer incorporates a color coded pH indicator The end user can visually inspect the solution and see that the mixture or buffer is at the proper pH If the mixed solution is purple the pH is too high for optimal digestion If the buffer or RISHzyme solution turns orange or yellow the pH is too low for optimal digestion Materials and Reagents Required But Not Provided Reagents and materials such as RISH in situ probes detection kits chromogens and ancillary reagents are not provided Refer to the ONCORE Automated Slide Staining System User Manual for a complete list of materials and reagents required Storage and Stability Store at 2 C to 8 C Do not use after expiration date printed on
5. vial The working solution is stable for 14 days after addition of RISHzyme to RISHzyme Buffer when stored at 2 C to 8 C Instructions for Use Mix RISHzyme in RISHzyme Buffer as desired see Reconstitution Dilution and Mixing Cap the vial and invert several times to thoroughly mix contents Uncap the vial and place in the ONCORE reagent tray The ONCORE will apply reagent as required in the selected protocol Refer to the ONCORE Automated Slide Staining System User Manual for detailed instructions on instrument operation and additional protocol options taal Biocare Medical 4040 Pike Lane Concord CA 94520 Tel 800 799 9499 wo CE USA Page 1 of 1 www biocare net Limitations This reagent has been optimized for use with ONCORE RISH probes detections and ancillary reagents The protocols for a specific application can vary These include but are not limited to fixation enzymatic digestion heat retrieval method incubation times and tissue section thickness Third party ISH probes may be used on the ONCORE however appropriate probe concentration and protocol parameters may depend upon multiple factors and must be empirically determined by the user 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 histopatholog
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