Further Information - Leica BIOSYSTEMS BOND Polymer Refine Detection DS9800 Mode D'emploi

Precautions
• Restricted to professional users.
• This detection system is intended for in vitro diagnostic use.
• To obtain a copy of the Material Safety Data Sheet contact your local distributor or regional office of Leica Biosystems, or
alternatively, visit the Leica Biosystems' web site, www.LeicaBiosystems.com
• 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
reagents or specimens. If reagents or specimens come in contact with sensitive areas, wash with copious amounts of water. Seek
medical advice.
• Consult Federal, State or local regulations for disposal of any potentially toxic components.
• Minimize microbial contamination of reagents or an increase in non-specific staining may occur.
• Incubation times or temperatures other than those specified may give erroneous results. Any such change must be validated by the
user .
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• Do not mix reagents from different detection systems.
Instructions for Use
BOND Polymer Refine Detection was developed for use on the BOND automated system. Operating parameters for application of the
detection system reagents on the BOND Processing Module have been optimized at Leica Biosystems. These can be displayed by
following the instructions in your BOND user documentation.
Product Specific Limitations
BOND Polymer Refine Detection has been optimized at Leica Biosystems for use with BOND ancillary reagents. Laboratories may
use their own primary antibodies provided they have been diluted to an appropriate concentration with BOND Primary Antibody Diluent
(Catalog No. AR9352). Users who deviate from recommended test procedures must accept responsibility for interpretation of patient
results under these circumstances.
The appropriate concentration of user's own primary antibodies may vary, due to variation in tissue fixation and the effectiveness
of antigen enhancement, and must be determined empirically. Negative reagent controls should be used when optimizing retrieval
conditions and primary antibody concentrations.
The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls.
They should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Troubleshooting
Refer to reference 4 for remedial action.
If the patient result does not correspond to the expected results with the use of controls, the test should be repeated.
If the staining result is not as expected, and you wish to troubleshoot performance of the instrument and detection system independently,
your local Leica representative can provide specific protocols. The detection kit must be used in conformance to the package instructions
and within the shelf life indicated on the product itself.

Further Information

Further information on immunostaining with BOND reagents, under the headings Principle of the Procedure, Materials Required,
Specimen Preparation, Quality Control, Assay Verification, Interpretation of Staining, Key to Symbols on Labels, and General Limitations
can be found in "Using BOND Reagents" in your BOND user documentation.
Bibliography
1. Clinical Laboratory Improvement Amendments of 1988, Final Rule 57 FR 7163 February 28, 1992.
2. List of substances which may be candidates for further scientific review and possible identification, classification and regulation as
potential occupational carcinogens. Fed Reg 1980; 45:157.
3. Villanova PA. National Committee for Clinical Laboratory Standards (NCCLS). Protection of laboratory workers from infectious
diseases transmitted by blood and tissue; proposed guideline. 1991; 7(9). Order Code M29-P.
4. JD Bancroft and A Stevens. Theory and Practice of Histological Techniques. 4
Date of Issue
06 November 2019
DS9800
Page 3
. Never pipette reagents by mouth and avoid contacting the skin and mucous membranes with
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Edition. Churchill Livingstone, New York. 1996.
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