Ki-67 [MIB-1]

Description

Ki-67 [MIB-1] is a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of Ki-67 protein by immunohistochemistry (IHC) in formalin-fixed paraffin-embedded (FFPE) human tissues. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. The Ki-67 nuclear antigen is associated with cell proliferation. It is found throughout the cell cycle that includes the G1, S, G2, and M phases; but not the (G0) phase.

SPECIFICATIONS

Specifications

INTENDED USE IVD
FORMAT ONCORE ProPrediluteQ SeriesUltraLineVALENT
VOLUME 20 ml25 ml6.0 ml60 Tests7 ml
SOURCE Mouse Monoclonal
CLONE MIB-1
ISOTYPE IgG1/kappa
ANTIGEN Human recombinant peptide corresponding to a 1002 bp Ki-67 cDNA fragment
LOCALIZATION Nuclear
POSITIVE CONTROL Colon cancer
REFERENCES

1. Key G, et al. New Ki-67-equivalent murine monoclonal antibodies (MIB 1-3) generated against bacterially expressed parts of the Ki-67 cDNA containing three 62 base pair repetitive elements encoding for the Ki-67 epitope. Lab Invest. 1993 Jun;68 (6):629-36.
2. Jansen RL, et al. MIB-1 labelling index is an independent prognostic marker in primary breast cancer. Br J Cancer. 1998 Aug; 78(4):460-5.
3. Goodson WH 3rd, et al. The functional relationship between in vivo bromodeoxyuridine labeling index and Ki-67 proliferation index in human breast cancer. Breast Cancer Res Treat. 1998 May; 49(2):155-64.
4. Center for Disease Control Manual. Guide: Safety Management, NO. CDC-22, Atlanta, GA. April 30, 1976 “Decontamination of Laboratory Sink Drains to Remove Azide Salts.”
5. Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory Workers from Occupationally Acquired Infections; Approved Guideline-Fourth Edition CLSI document M29-A4 Wayne, PA 2014.

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