Leica BIOSYSTEMS BOND PA0016 Mode D'emploi page 3

BOND Ready-To-Use Primary Antibody
™
p16 (6H12)
Catalog No: PA0016
Intended Use
This reagent is for in vitro diagnostic use.
p16 (6H12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human p16 protein in
formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-
MAX system and Leica BOND-III system).
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 and Explanation
Immunohistochemical techniques can be used to demonstrate the presence of antigens in tissue and cells (see "Using BOND Reagents"
in your BOND user documentation). p16 (6H12) primary antibody is a ready to use product that has been specifically optimized for use
with BOND Polymer Refine Detection. The demonstration of human p16 protein is achieved by first allowing the binding of p16 (6H12)
to the section, and then visualizing this binding using the reagents provided in the detection system. The use of these products, in
combination with the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system), reduces the possibility
of human error and inherent variability resulting from individual reagent dilution, manual pipetting and reagent application.
Reagents Provided
p16 (6H12) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline
with carrier protein, containing 0.35 % ProClin™ 950 as a preservative.
Total volume = 7 mL.
Clone
6H12
Immunogen
Prokaryotic recombinant fusion protein corresponding to the entire human p16 molecule.
Specificity
Human p16 protein.
Ig Class
IgG2b
Total Protein Concentration
Approx 10 mg/mL.
Antibody Concentration
Greater than or equal to 5 mg/L as determined by ELISA.
Dilution and Mixing
p16 (6H12) primary antibody is optimally diluted for use on the BOND system (includes Leica BOND-MAX system and Leica BOND-III
system). Reconstitution, mixing, dilution or titration of this reagent is not required.
Materials Required But Not Provided
Refer to "Using BOND Reagents" in your BOND user documentation for a complete list of materials required for specimen treatment and
immunohistochemical staining using a BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
Storage and Stability
Store at 2–8 °C. Do not use after the expiration date indicated on the container label.
The signs indicating contamination and/or instability of p16 (6H12) are: turbidity of the solution, odor development, and presence of
precipitate.
Return to 2–8 °C immediately after use.
Storage conditions other than those specified above must be verified by the user
Precautions
• This product is intended for in vitro diagnostic use.
• The concentration of ProClin™ 950 is 0.35 %. 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 gloves when handling reagents.
• 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 precautions². 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.
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PA0016
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