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Order 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

Reflex Tests

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

Testing Algorithm

Cases that are not able to be scanned for automated analysis will be changed to the manual process for analysis.

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.

Reference Values

Varies by tumor type; values reported from 0% to 100%

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.

 

Ki-67 (MIB-1)-stained slides are scanned using the Leica Aperio GT450 digital scanner. The captured digital image is analyzed in Aiforia by an artificial intelligence algorithm. The Aiforia software renders a percentage of positive-staining tumor nuclei. A technologist reviews the analyzed digital image and ensures at least 80% of the total invasive or metastatic cancer is analyzed appropriately. The Aiforia data and corresponding slide are reviewed by a pathologist for final interpretation.(Unpublished Mayo method)

Day(s) Performed

Monday through Friday

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

88361