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HelpMayo Test ID KIBM Ki-67(MIB-1), Breast, Semi-Quantitative Immunohistochemistry, Manual
Ordering Guidance
Ki-67 immunohistochemistry testing on intracystic papillary carcinoma and solid papillary carcinoma, without clearly stating invasive carcinoma, is not appropriate and will be canceled without processing.
Shipping Instructions
Attach the green pathology address label included in the kit to the outside of the transport container.
Necessary Information
1. Pathologist's name, address, and phone number are required.
2. Include accompanying pathology report stating the final diagnosis. If not available, a preliminary diagnosis is acceptable only if it refers to invasive or metastatic breast carcinoma.
Specimen Required
This is not an orderable test. Order PATHC / Pathology Consultation. The consultant will determine the need for special stains.
Supplies: Pathology Packaging Kit (T554)
Specimen Type:
Preferred: Formalin-fixed, paraffin-embedded tissue block containing invasive or metastatic breast carcinoma
Acceptable: 2 unstained sections, containing invasive or metastatic breast carcinoma, on charged slides cut at 4 microns <1 month ago. Tissue on the slides should have been fixed in 10% neutral buffered formalin.
Submission Container/Tube: Pathology Packaging Kit (T554)
Collection Instructions: Submit paraffin-embedded invasive or metastatic breast carcinoma tissue.
Additional Information: Paraffin block will be returned with the final report.
Useful For
Determining proliferation of tumor cells in paraffin-embedded tissue blocks from patients diagnosed with breast carcinoma
Special Instructions
Method Name
This is not an orderable test. Order PATHC / Pathology Consultation. The consultant will determine the need for special stains.
Immunohistochemistry, Manual Semi-Quantitation
Reporting Name
Ki67 Breast IHC ManualSpecimen Type
SpecialSpecimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Special | Ambient (preferred) | ||
| Refrigerated | |||
Reject Due To
No specimen should be rejected.Clinical Information
Ki-67 (MIB-1 clone) is a monoclonal antibody that reacts with cells undergoing DNA synthesis by binding to the Ki-67 antigen, a marker known to be expressed only in proliferating cells. By measuring the amount of tumor cells expressing Ki-67, an estimate of DNA synthesis can be determined. Studies suggest that Ki-67 (MIB-1) analysis of paraffin-embedded tissue specimens may provide useful prognostic information in various tumor types.
Reference Values
This is not an orderable test. Order PATHC / Pathology Consultation. The consultant will determine the need for special stains.
Varies by tumor type; values reported from 0% to 100%
Interpretation
Results will be reported as a percentage of tumor cells staining positive for Ki-67(MIB-1). Quantitative Ki-67 (MIB-1) results should be interpreted within the clinical context for which the test was ordered.
Cautions
The paraffin block analyzed must be representative of the patient's tumor.
Test results should be interpreted in the context of clinical findings and other laboratory data.
Clinical Reference
1. Urruticoechea A, Smith IE, Dowsett M: Proliferation marker Ki-67 in early breast cancer. J Clin Oncol 2005 Oct 1;23(28):7212-7220
2. de Azambuja E, Cardoso F, de Castro G Jr, et al: Ki-67 as prognostic marker in early breast cancer: a meta-analysis of published studies involving 12,155 patients. Br J Cancer 2007 May 21;96(10):1504-1513
Method Description
A 4-micron thick section is cut from the paraffin block. The section is stained with an immunoperoxidase method using the monoclonal antibody Ki-67 (MIB-1 clone). This is the paraffin nuclear epitope to the Ki-67 antigen. Any nucleus that has an antigen-antibody complex will cause the bright-field, brown chromogen, diaminobenzidine (DAB), to precipitate onto it. All nuclei, both DAB positive and negative, are counterstained with diluted hematoxylin.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
4 to 6 daysSpecimen Retention Time
Until 1 week after results are reportedPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
88360
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| KIBM | Ki67 Breast IHC Manual | 85330-9 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 71669 | Interpretation | 85330-9 |
| 71670 | Participated in the Interpretation | No LOINC Needed |
| 71671 | Report electronically signed by | 19139-5 |
| 71672 | Material Received | 81178-6 |
| MA035 | Tumor type | 44638-5 |
| MA036 | Tumor classification | 21918-8 |
| 71673 | Disclaimer | 62364-5 |
| 71844 | Case Number | 80398-1 |