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Test Code KI67B Ki-67(MIB-1), Breast, Quantitative Immunohistochemistry, Automated


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.

 

If ordering for diagnostic purposes, order PATHC / Pathology Consultation and request the stain.



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


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 less than 1 month ago. Tissue on the slides should have been fixed in 10% neutral buffered formalin. Also send one hematoxylin and eosin-stained slide if possible.

Submission Container/Tube: Pathology Packaging Kit

Collection Instructions: Submit paraffin-embedded invasive or metastatic breast carcinoma tissue.

Additional Information: Paraffin block will be returned with the final report.


Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Oncology Test Request (T729)

-Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763)

Useful For

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

Disease States

  • Breast cancer

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
KIBM Ki67 Breast IHC Manual No No

Method Name

Immunohistochemistry, Automated Quantitation

Reporting Name

Ki67 Breast IHC Automated

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 and predictive information in various tumor types.

Reference Values

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

88361