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Test Code KINM Ki-67(MIB-1), Gastrointestinal/Pancreatic Neuroendocrine Tumors, Quantitative Immunohistochemistry, Manual

Reporting Name

Ki67 GI/Pancreas NET IHC Manual

Useful For

Determining proliferation of tumor cells in paraffin-embedded tissue blocks from patients diagnosed with neuroendocrine tumors of the pancreas or gastrointestinal tract including metastases

Testing Algorithm

Includes pathology consultation charged separately.

Method Name

This is not an orderable test. Order PATHC / Pathology Consultation. The consultant will determine the need for special stains.

 

Immunohistochemistry, Semi- Quantitation, Hot-Spot Technique

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Special


Ordering Guidance


This is not an orderable test. If ordering for diagnostic purposes, order PATHC / Pathology Consultation and request the stain.



Shipping Instructions


Attach the green "Attention Pathology" address label (T498) to the outside of the transport container before putting into the courier mailer.



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.



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 neuroendocrine tumor of the pancreas or gastrointestinal (GI) tract including metastases.

Acceptable: 2 unstained sections, containing neuroendocrine tumor of the pancreas or GI tract including metastases, 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

Collection Instructions: Submit formalin-fixed, paraffin-embedded tissue block

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


Specimen Stability Information

Specimen Type Temperature Time Special Container
Special Ambient (preferred)
  Refrigerated 

Reject Due To

No specimen should be rejected.

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%

Day(s) Performed

Monday through Friday

CPT Code Information

88360

LOINC Code Information

Test ID Test Order Name Order LOINC Value
KINM Ki67 GI/Pancreas NET IHC Manual 29593-1

 

Result ID Test Result Name Result LOINC Value
71674 Interpretation 29593-1
71675 Participated in the Interpretation No LOINC Needed
71676 Report electronically signed by 19139-5
71677 Material Received 81178-6
71678 Disclaimer 62364-5
71845 Case Number 80398-1

Secondary ID

71667

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.

Interpretation

Results will be reported as a percentage of tumor cells staining positive for Ki-67(MIB-1). Semi-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. La Rosa S. Diagnostic, Prognostic, and Predictive Role of Ki67 Proliferative Index in Neuroendocrine and Endocrine Neoplasms: Past, Present, and Future. Endocr Pathol. 2023;34(1):79-97. doi:10.1007/s12022-023-09755-3

2. Nagtegaal ID, Odze RD, Klimstra D, et al. The 2019 WHO classification of tumours of the digestive system. Histopathology. 2020;76(2):182-188. doi:10.1111/his.13975

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)

Specimen Retention Time

1 week after results are reported. Material made at Mayo Clinic may be retained at Mayo Clinic indefinitely.

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.

Report Available

4 to 6 days