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PA0027
Page 2
Intended Use
This reagent is for in vitro diagnostic use.
Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identication by light microscopy of human
HMB45 antigen in formalin-xed, parafn-embedded tissue by immunohistochemical staining using an automated Bond 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 qualied 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). Melanoma Marker (HMB45) primary antibody is a ready-to-use product that is recommended for use
with either the Bond Polymer Rene Detection or Bond Polymer Rene Red Detection. The demonstration of human HMB45 antigen is
achieved by rst allowing the binding of Melanoma Marker (HMB45) to the section, and then visualizing this binding using the reagents
provided in the detection system. The use of these products, in combination with an automated Bond system, reduces the possibility of
human error and inherent variability resulting from individual reagent dilution, manual pipetting and reagent application.
Reagents Provided
Melanoma Marker (HMB45) 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
HMB45.
Immunogen
Extract of pigmented melanoma metastases from lymph nodes.
Specicity
Human HMB45 antigen.
Subclass
IgG1, Kappa.
Total Protein Concentration
Approx 10 mg/mL.
Antibody Concentration
Greater than or equal to 1.3 mg/L as determined by ELISA.
Dilution and Mixing
Melanoma Marker (HMB45) primary antibody is optimally diluted for use on the automated Bond 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 the automated Bond 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 Melanoma Marker (HMB45) are: turbidity of the solution, odor development, and
presence of precipitate.
Return to 2–8 °C immediately after use.
Storage conditions other than those specied above must be veried by the user
1
.
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 ofce of Leica Biosystems, or alternatively,
visit the Leica Biosystems Web site, www.LeicaBiosystems.com
• Specimens, before and after xation, and all materials exposed to them, should be handled as if capable of transmitting infection and
disposed of with proper precautions
2
. 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.
Bond
™
Ready-To-Use Primary Antibody
Melanoma Marker (HMB45)
Catalog No: PA0027