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HelpTest 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)
Secondary ID
71503Useful 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 AutomatedSpecimen Type
SpecialSpecimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Special | Ambient (preferred) | ||
| Refrigerated | |||
Reject Due To
No specimen should be rejected.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%
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).
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.
Ki-67 (MIB-1)-stained slides are scanned using the Leica Aperio GT450 digital scanner. The captured digital image is analyzed using a validated AI (Artificial Intelligence) algorithm by Aiforia that calculates the percentage of positive staining tumor nuclei. The Aiforia data and corresponding slide are reviewed by a pathologist for final interpretation.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
4 to 6 daysSpecimen Retention Time
1 week after results are reported; Material made at Mayo Clinic may be retained at Mayo Clinic indefinitely.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 |