Leica HMB45 Manuel D’Utilisation

PA0027 

Page 2

This reagent is for in vitro diagnostic use.
Melanoma Marker (HMB45) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human 

HMB45 antigen in formalin-fixed, paraffin-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 qualified pathologist.

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 Refine Detection or Bond Polymer Refine Red Detection. The demonstration of human HMB45 antigen is 

achieved by first 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.

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.

HMB45.

Extract of pigmented melanoma metastases from lymph nodes.

Human HMB45 antigen.

IgG1, Kappa.

Approx 10 mg/mL.

Greater than or equal to 1.3 mg/L as determined by ELISA.

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.

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.

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 specified above must be verified by the user

1

.

•  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 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.