This antibody is intended for in vitro diagnostic (IVD) use.
The Ki-67 (IHC067) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods. Use of this antibody is indicated, subsequent to clinical differential diagnoses of diseases, as an aid in the identification of proliferating cells in normal and neoplastic tissues within the context of antibody panels, the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist.
Ki-67 is a nuclear, non-histone protein that is expressed only during active phases of the cell cycle (G1, S, G2 and M), but not in the resting phases (G0 and G1 early phase). Although the antigen has also been associated with ribosomal RNA transcription, it is strongly linked to cell proliferation and has thus been indicated as an effective marker in grading the proliferation rate of tumors, including those of the brain, breast, cervix, and prostate.