This antibody is intended for in vitro diagnostic (IVD) use.
Ventana Medical Systems' (Ventana) CONFIRM anti-Ki-67 (30-9) Primary Antibody is a rabbit monoclonal antibody (IgG) directed against C-terminal portion of Ki-67 antigen. Staining for Ki-67 can be used to aid in assessing the proliferative activity of normal and neoplastic tissue.1,2,3 This antibody is intended for use to identify stained proliferating cells by light microscopy in sections of formalin-fixed, paraffin-embedded tissue on a Ventana automated slide stainer.
The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.
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- College of American Pathologists Laboratory Accreditation Program, Anatomic Pathology Checklist, 2001.
- NCCLS. Quality Assurance for Immunocytochemistry: Approved Guideline. NCCLS document MM4-A- (ISBN 1-56238-396-5).
- NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA, 1999.
- Herman GE, Elfont EA. The taming of immunohistochemistry: the new era of quality control. Biotech Histochem 66(4): 194-199, 1991.
- Omata M, Liew CT, Ashcavai M, Peters RL. Nonimmunologic binding of horseradish peroxidase to hepatitis B surface antigen. A possible source of error in immunohistochemistry. Am J Clin Pathol 73(5): 626-32, 1980.
- Nadji M, Morales AR. Immunoperoxidase: part 1. The technique and its pitfalls. Lab Med 14: 767, 1983.
- Roche PC, Hsi ED. Immunohistochemistry-Principles and Advances. Manual of Clinical Laboratory Immunology, 6th edition. (NR Rose Ed.) ASM Press, 2002.