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Test Code 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.


Forms

1. Pathology/Cytology Information (T707) in Special Instructions

Useful For

Determining proliferation of tumor cells in paraffin-embedded tissue blocks from patients diagnosed with breast carcinoma

Disease States

  • Breast cancer

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 Manual

Specimen Type

Special

Specimen 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%

Day(s) Performed

Monday through Friday

Report Available

4 to 6 days

Performing 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