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HelpTest Code KINET Ki-67(MIB-1), Gastrointestinal/Pancreatic Neuroendocrine Tumors, Quantitative Immunohistochemistry, Automated
Reporting Name
Ki67 GI/Pancreas NET IHC AutomatedPerforming Laboratory
Mayo Clinic Laboratories in Rochester
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
Method Name
Immunohistochemistry, Automated Quantitation, Hot-Spot Technique
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.
Specimen Type
SpecialSpecimen 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%
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).
Day(s) Performed
Monday through Friday
Report Available
4 to 6 daysTest 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 |
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)
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.