Monoclonal Mouse Anti-Human

Ki-67 Antigen

Clone MIB-1

With more than 4000 literature citations, the MIB-1 antibody has now been established as the reference monoclonal mouse antibody for the demonstration of the Ki-67 antigen in formalin-fixed, paraffin-embedded specimens.

The Ki-67 antigen is a large nuclear protein (345, 395 kDa) preferentially expressed during all active phases of the cell cycle (G1, S, G2 and M-phases), but absent in resting cells (G0-phase). In diagnostic histopathology and cell biology, antibodies against the Ki-67 antigen have proven valuable by allowing direct monitoring of the growth fraction of normal and neoplastic cells.

References
  1. Gerdes J, Becker MH, Key G, Cattoretti G. Immunohistological detection of tumour growth fraction (Ki-67 antigen) in formalin-fixed and routinely processed tissues. J Pathol 1992;168:85-6.
  2. Cattoretti G, Becker MH, Key G, Duchrow M, Schlüter C, Galle J, et al. Monoclonal antibodies against recombinant parts of the Ki-67 antigen (MIB 1 and MIB 3) detect proliferating cells in microwave-processed formalin-fixed paraffin sections. J Pathol 1992;168:357-63.
  3. Scholzen T, Gerdes J. The Ki-67 protein: from the known and the unknown [review]. J Cell Physiol 2000;182:311-22.

Burkitt lymphoma (FFPE) stained with FLEX Anti-Ki-67 Antigen, Code IR626/IS626.

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Burkitt lymphoma/leukemia. Virtually all the neoplastic cells show a distinct nuclear staining reaction.

Clinical application for IR626/IS626. For identification of proliferating cells in normal and neoplastic tissues such as Burkitt lymphoma/leukemia, colon adenocarcinoma, soft-tissue sarcoma, prostatic adenocarcinoma and breast carcinoma.

Disclaimer: Due to variances among color computer monitors, the colors you see on your screen may not be the exact colors of the stain. The image you see should be considered close renditions to the actual stain.

  • Optimized staining performance of both high- and low-expression structures
  • Crisp and clear staining with no background
  • Optimal laboratory efficiency with ready-to-use antibodies on Dako Autostainer Link 48
The staining performance of all antibodies has been defined, tested and approved through collaboration with leading international pathologists. Check the Atlas of Stains - a guide to diagnostic accuracy

Intended Use
For in vitro diagnostic use.

FLEX Monoclonal Mouse Anti-Human Ki-67 Antigen, Clone MIB-1, Ready-to-Use (Link), is intended for use in immunohistochemistry together with Autostainer Link instruments. This antibody is useful for the identification of the Ki-67 antigen in normal and neoplastic cells, for example in soft-tissue sarcoma (1), prostatic adenocarcinoma (2), and breast carcinoma (3). Differential identification is aided by the results from a panel of antibodies. 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.
Immunogen
Human recombinant peptide corresponding to a 1002 bp Ki-67 cDNA fragment (8).
Specificity
In Western blotting of lysates of the multiple myeloma cell line, IM-9, the MIB-1 antibody labels bands of 345 and 395 kDa, identical to the bands labeled by the original Ki-67 antibody. Furthermore, Western blotting and competitive binding experiments clearly demonstrate that MIB-1, like the original Ki-67 antibody, reacts with an epitope encoded by a 66 bp repetitive element in the Ki-67 gene.

In immunohistochemistry, the MIB-1 and the Ki-67 antibodies provide identical staining patterns on serial tonsillar frozen sections (8). The MIB-1 antibody recognizes native Ki-67 antigen and recombinant fragments of the Ki-67 molecule (8).
Reagent Provided
Ready-to-use monoclonal mouse antibody provided in liquid form in a buffer containing stabilizing protein and 0.015 mol/L sodium azide.

Clone: MIB-1 (8). Isotype: IgG1, kappa.
References
  1. Huuhtanen RL, Blomqvist CP, Wiklund TA, Böhling TO, Virolainen MJ, Tukiainen EJ, et al. Comparison of the Ki-67 score and S-phase fraction as prognostic variables in soft-tissue sarcoma. Br J Cancer 1999; 79:945-51.
  2. Borre M, Bentzen SM, Nerstrøm B, Overgaard J. Tumor cell proliferation and survival in patients with prostate cancer followed expectantly. J Urol 1998; 159:1609-14.
  3. Seshadri R, Leong AS-Y, McCaul K, Firgaira FA, Setlur V, Horsfall DJ. Relationship between p53 gene abnormalities and other tumor characteristics in breast-cancer prognosis [published erratum appears in Int J Cancer 1996;69:354]. Int J Cancer 1996; 69:135-41.
  1. Key G, Becker MHG, Baron B, Duchrow M, Schlüter C, Flad H-D, 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; 68:629-36.
ProductSize
This product is CE-marked according to the EU IVD Directive 98/79/ECIR626 Clone MIB-1
Specification Sheet
Safety Data Sheet:
Non-hazard classification statement
60 tests, 12 mL
Product No. IR62661-2

RECOMMENDED COMPANION PRODUCTS

StepProductSize
Pre-treatmentEnVision™ FLEX Target Retrieval Solution, Low pH (Code K8005)
3-in-1 procedure using PT Link
3 x 30 mL
Product No. K800521-2
Antibody Dilution
Ready-to-use / Prediluted
 
Negative ControlFLEX Negative Control, Mouse (Code IR750)
Positive tissue: Tonsil
120 tests, 24 mL
Product No. IR75066-2
Visualization SystemEnVision™ FLEX (Code K8000)
Use Low pH Target Retrieval Solution
400-600 tests
Product No. K800021-2
CounterstainHematoxylin (Link) (Code K8008)
Non-aqueous, permanent mounting medium is required
3 x 45 mL, 400-600 tests
Product No. K800821-2
Glass SlidesFLEX IHC Microscope Slides (Code K8020)
Recommended for greater adherence
5 x 100 slides
Product No. K802021-2

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