Leica Biosystems ChromoPlex 1 Dual Detection for BOND - Manual (Page 4)

DS9477
Page 3
Precautions
WARNING - some mounting media may cause the red chromogen to crystallize or fade. •
DO NOT USE DPX, Entellan • ® , Leica CV Mount, Eukitt ® quick-hardening mounting medium, Surgipath MM 24 ® , Surgipath Sub-X ® and
Pertex mounting media as they are not suitable for use with this product.
Fading or crystallization has not been observed with: Leica CV Ultra Mounting Media (Cat 14070937891), Poly-Mount
• ® (Polysciences
Inc. Cat 08381), VectaMount ™ (Vector Laboratories Cat H-5000) and Limonene Mount (Electron Microscopy Sciences Cat 17987-01).
The compatibility of other mounting media should be fully validated by the user prior to use. Failure to do so may result in a reduction •
of staining due to fading or crystallization.
The concentration of ProClin 950, the preservative used in some BOND detection system components, is 0.5% or 0.09%. It contains
•
the active ingredient 2-methyl-4-isothiazolin-3-one, and may cause irritation to the skin, eyes, mucous membranes and upper
respiratory tract. Wear disposable nitrile gloves when handling reagents.
3,3’-Diaminobenzidine tetrahydrochloride (a constituent of DAB Part 1) is a potential carcinogen
• 2 and may cause irritation to the skin,
eyes, mucous membranes and upper respiratory tract. Wear disposable nitrile gloves, handle with care and do not breathe fumes.
Dispose of according to local regulations.
The activator and substrate solutions may cause irritation to the skin, eyes, mucous membranes and upper respiratory tract. Wear
•
disposable nitrile gloves when handling reagents. Dispose of according to local regulations.
To obtain a copy of the Material Safety Data Sheet contact your local distributor or regional office of Leica Biosystems. 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 3 . Never pipette reagents by mouth and avoid contacting the skin and mucous membranes with
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 1 .
Do not mix reagents from different detection systems. •
Instructions for Use
The ChromoPlex 1 Dual Detection was developed for use on the BOND automated system using *IHC Protocol K. Operating parameters
for application of the detection system reagents on the BOND Processing Module have been optimized by Leica Biosystems. These can
be displayed by following the instructions in your BOND user documentation.
Use rapid alcohol/xylene dehydration.
After completing or aborting *IHC Protocol K there is a delay of approximately 15 minutes before the BOND system will start another run
on the same Slide Staining Assembly.
Product Specific Limitations
ChromoPlex 1 Dual Detection has been optimized at Leica Biosystems for use with BOND ancillary reagents. Laboratories may use their
own primary antibody cocktails 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.
Some mounting media are not compatible with ChromoPlex 1 Dual Detection (see
Precautions).
Contact your local distributor or regional office of Leica Biosystems for further information.
Troubleshooting
Refer to reference 4 for remedial action.
Contact your local distributor or the regional office of Leica Biosystems to report unusual staining.
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
Clinical laboratory Improvement Amendments of 1988, Final Rule 57 FR 7163 February 28, 1992. 1.
List of substances which may be candidates for further scientific review and possible identification, classification and regulation as 2.
potential occupational carcinogens. Fed Reg 1980; 45:157.
Villanova PA. National Committee for Clinical Laboratory Standards (NCCLS). Protection of laboratory workers from infectious
3.
diseases transmitted by blood and tissue; proposed guideline. 1991; 7(9). Order code M29-P.
Bancroft JD and Stevens A. Theory and Practice of Histological Techniques. 4
4. th Edition. Churchill Livingstone, New York. 1996.
ProClin 950 is a trademark of Supelco, a part of Sigma-Aldrich Corporation.
Date of Issue
16 November 2011