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Test Code KIBM Ki67 Breast IHC Manual


Advisory Information


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.

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

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

Pathology Test Request Form (T246) (http://www.mayomedicallaboratories.com/it-mmfiles/pathology-request-form.pdf)

Oncology Test Request Form (T729) (http://www.mayomedicallaboratories.com/it-mmfiles/oncology-request-form.pdf

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

Immunohistochemistry, Manual Semi-Quantitation

Reporting Name

Ki67 Breast IHC Manual

Specimen Type

Special

Specimen Stability Information

Specimen Type Temperature Time
Special Ambient (preferred)
  Refrigerated 

Reject Due To

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

NA

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) and Time(s) Performed

Monday through Friday; 8 a.m.-5 p.m.

Analytic Time

2 days

Specimen Retention Time

Until 1 week after results are reported

Performing Laboratory

Mayo Medical 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 U.S. Food and Drug Administration.

CPT Code Information

88360

LOINC Code Information

Test ID Test Order Name Order LOINC Value
KIBM Ki67 Breast IHC Manual In Process

 

Result ID Test Result Name Result LOINC Value
71669 Interpretation In Process
71670 Participated in the Interpretation No LOINC Needed
71671 Report electronically signed by 19139-5
71672 Material Received 81178-6
MA035 Tumor type In Process
MA036 Tumor classification In Process
71673 Disclaimer 62364-5
71844 Case Number 80398-1