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


Ordering Guidance


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


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.


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 neuroendocrine tumors of the pancreas or gastrointestinal tract including metastases

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
KINM Ki67 GI/Pancreas NET 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, Hot-Spot Technique

Reporting Name

Ki67 GI/Pancreas NET IHC Automated

Specimen Type

Special

Specimen Stability Information

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

Reference Values

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.

 

The scoring method using Aiforia artificial intelligence for image analysis was developed and validated in the Biomarker and Image Analysis Laboratory, Department of Laboratory Medicine and Pathology, Mayo Clinic (see Method Description).

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

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

CPT Code Information

88361

LOINC Code Information

Test ID Test Order Name Order LOINC Value
KINET Ki67 GI/Pancreas NET IHC Automated 29593-1

 

Result ID Test Result Name Result LOINC Value
71385 Interpretation 29593-1
71402 Participated in the Interpretation No LOINC Needed
71403 Report electronically signed by 19139-5
71404 Material Received 81178-6
71628 Disclaimer 62364-5
71842 Case Number 80398-1