RISHzymeTM for ONCORE

RISHzymeTM for ONCORE
RISHzymeTM for ONCORE
Enzyme Pretreatment Reagent for in situ Hybridization
Procedures on the ONCORE Automated Slide Stainer
ISO
9001&13485
CERTIFIED
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 & Explanation:
RISHzymeTM for ONCORE is a digestive enzyme used in the pretreatment of formalinfixed 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. RISHzymeTM 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 RISHTM Retrieval for ONCORE, a synergistic effect on probe accessibility 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 RISHTM 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 2ºC to 8ºC. Do not use after expiration date printed on vial. The working
solution is stable for 14 days after addition of RISHzymeTM to RISHzymeTM Buffer,
when stored at 2°C to 8°C.
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 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
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/.
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. 1st 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.
Instructions for Use:
Mix RISHzymeTM in RISHzymeTM 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.
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