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


Shipping Instructions


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



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.

Container/Tube: Pathology Packaging Kit (T554)

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:

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)

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 Ambient (preferred)
  Refrigerated 

Reject Due To

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

NA

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.

Cautions

Due to the limitations of the Aperio system (fixed rectangle size and the inability of the machine to distinguish stroma, benign, etc) small or focal tumors will be reflexed (by a pathologist) to a manual semiquantitation method rather than an automated measurement.

Clinical Reference

1. Bosman F, Carneiro F, Hruban R, et al: WHO classification of tumours of the digestive system. Lyon: International Agency for Research on Cancer, 2010

2. Hochwald SN, Zee S, Conlon KC, et al: Prognostic factors in pancreatic endocrine neoplasms: an analysis of 136 cases with a proposal for low-grade and intermediate-grade groups. J Clin Oncol 2002;20:2633-2642

3. Klimstra DS, Modlin IR, Coppola D, et al: The pathologic classification of neuroendocrine tumors: a review of nomenclature, grading, and staging systems. Pancreas 2009;39:707-712

4. Klimstra DS, Modlin IR, Adsay NV, et al: Pathology reporting of neuroendocrine tumors: application of the Delphic consensus process to the development of a minimum pathology data set. Am J Surg Pathol 2010;34:300-313

5. Pathology and Genetics Tumours of Endocrine Organs. Edited by RA DeLellis, RV Lloyd, PU Heitz, C Eng. IARC Press, 2004

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) quantification using the Aperio system in neuroendocrine tumors has been validated by our laboratory. Ki-67 (MIB-1)-stained slides are scanned using the Aperio ScanScope instrument, which captures digital images of the patient slide. A technologist views the digitized image on a computer monitor and using a rectangle tool available in ImageScope (Aperio Technologies Inc), identifies up to ten "hot" regions of the most intensely staining areas within the tumor. The selected areas are then analyzed using an image analysis algorithm that renders the percentage of positive-staining tumor nuclei. The slides and test results are then reviewed by a pathologist who provides a final interpretation.(Unpublished Mayo method)

Day(s) and Time(s) Performed

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

Analytic Time

2 days

Specimen Retention Time

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

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
KINET Ki67 GI/Pancreas NET IHC Automated In Process

 

Result ID Test Result Name Result LOINC Value
71385 Interpretation In Process
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