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Test Code MISC2MAYOKIBM 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.


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

Secondary ID


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 Manual

Specimen Type


Specimen Stability Information

Specimen Type Temperature Time Special Container
Special Ambient (preferred)

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%


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.

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 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. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information


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