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Test Code KI67 Ki-67 (MIB-1) Immunostain, Technical Component Only


Advisory Information


This test includes only technical performance of the stain (no pathologist interpretation is performed). If diagnostic consultation by a pathologist is required order PATHC / Pathology Consultation.



Shipping Instructions


Attach the green pathology address label and the pink Immunostain Technical Only label included in the kit to the outside of the transport container.



Specimen Required


Supplies: Immunostain Technical Only Envelope (T693)

Specimen Type: Tissue

Container/Tube: Immunostain Technical Only Envelope (T693)

Preferred: 2 Unstained positively charged glass slides (25- x 75- x 1-mm) per test ordered; sections 4-microns thick.

Acceptable: Formalin-fixed, paraffin-embedded (FFPE) tissue block


Secondary ID

70481

Useful For

A marker of proliferation in neoplasms

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
IHTOI IHC Initial, Tech Only No No
IHTOA IHC Additional, Tech Only No No

Method Name

Immunohistochemistry

Reporting Name

Ki-67 (MIB-1) IHC, Tech Only

Specimen Type

TECHONLY

Specimen Stability Information

Specimen Type Temperature Time
TECHONLY Ambient (preferred)
  Refrigerated 

Reject Due To

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

Wet/frozen tissue
Cytology smears
Nonformalin fixed tissue 
Nonparaffin embedded tissue
Noncharged slides
ProbeOn slides

Clinical Information

Ki-67 (antibody clone MIB-1), is a nuclear protein playing a pivotal role in maintaining cell proliferation. Ki-67 is present in all non-G0 phases of the cell cycle. Beginning in the mid-G1, the level increases through S and G2 to reach a peak in M phase. In the end of M phase, it is rapidly catabolized. Ki-67 has been employed as a marker of proliferation and, hence, prognosis in neoplasms of many types, such as malignant lymphomas, prostatic and breast adenocarcinomas, astrocytic neoplasms, and soft tissue neoplasms.

Interpretation

This test includes only technical performance of the stain (no pathologist interpretation is performed). Mayo Clinic cannot provide an interpretation of tech only stains outside the context of a pathology consultation. If an interpretation is needed, refer to test code PATHC / Pathology Consultation for a full diagnostic evaluation or second opinion of the case. All material associated with the case is required. Additional specific stains may be requested as part of the pathology consultation, and will be performed as necessary at the discretion of the Mayo pathologist.

 

The positive and negative controls are verified as showing appropriate immunoreactivity and documentation is retained at Mayo Clinic Rochester. If a control tissue is not included on the slide, a scanned image of the relevant quality control tissue is available upon request. Contact 855-516-8404.

 

Interpretation of this test should be performed in the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.

Clinical Reference

1. Yerushalmi R, Woods R, Ravdin PM et al: Ki67 in breast cancer: prognostic and predictive potential. Lancet 2010;11:174-183

2. Leonardo E, Volante M, Barbareschi M, et al: Cell membrane reactivity of MIB-1 antibody to Ki67 in human tumors: fact or artifact? Appl Immunohistochem Mol Morphol 2007;15(2):220-223

3. Potemski P, Pluciennik E, Bednarek AK, et al: Ki-67 expression in operable breast cancer: a comparative study of immunostaining and a real-time RT-PCR assay. Pathol Res Pract 2006;202:491-495

4. Li R, Heydon K, Hammond ME, et al: Ki-67 staining index predicts distant metastasis and survival in locally advanced prostate cancer treated with radiotherapy: an analysis of patients in Radiation Therapy Oncology Group Protocol 86-10. Clin Cancer Res 2004;10:4118-4124

5. Trihia H, Murray S, Price K, et al: Ki-67 expression in breast carcinoma-its association with grading systems, Clinical parameters, and other prognostic factors-a surrogate marker? Cancer 2003;97(5):1321-1331

Day(s) and Time(s) Performed

Monday through Friday

Analytic Time

1 day

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

88342-TC, primary

88341-TC, if additional IHC

LOINC Code Information

Result ID Test Result Name Result LOINC Value
70793 Ki-67 (MIB-1) IHC, Tech Only No LOINC Needed