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Test ID 89027 Ki-67(MIB-1), Breast, Quantitative Immunohistochemistry, Automated

Useful For

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

Testing Algorithm

If ordering for diagnostic purposes, order 70012 / Pathology Consultation and request the stain.

Method Name

Immunohistochemistry, Automated Quantitation

Reporting Name

Ki-67(MIB-1), Breast IHC, Automated

Specimen Type

Varies

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 (Supply T554)

Collection Instructions:

1. Submit paraffin-embedded invasive or metastatic breast carcinoma tissue.

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.

3. Attach the green pathology address label included in the kit to the outside of the transport container.

Additional Information:                           

1. Pathologist's name, address, and phone number are required.

2. Paraffin block will be returned with the final report.

3. 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.

Forms: 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)

Specimen Stability Information

Specimen Type Temperature Time
Varies Ambient (preferred)
  Refrigerated 

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

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

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.

Day(s) Performed

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

Report Available

2 days

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

88361

NY State Approved

Yes