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HelpTest Code KI67 Ki-67 (MIB-1) Immunostain, Technical Component Only
Reporting Name
Ki-67 (MIB-1) IHC, Tech OnlyUseful 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 |
Testing Algorithm
For the initial technical component only immunohistochemical (IHC) stain performed, the appropriate bill-only test ID will be reflexed and charged (IHTOI). For each additional technical component only IHC stain performed, an additional bill-only test ID will be reflexed and charged (IHTOA).
Method Name
Immunohistochemistry (IHC)
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
TECHONLYOrdering Guidance
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 "Attention Pathology" address label (T498) and the pink Immunostain Technical Only label included in the kit to the outside of the transport container.
Specimen Required
Specimen Type: Tissue
Supplies: Immunostain Technical Only Envelope (T693)
Container/Tube: Immunostain Technical Only Envelope
Preferred:
-Formalin-fixed, paraffin-embedded tissue block
OR
-2 Unstained, positively charged glass slides (25- x 75- x 1-mm) per test ordered; sections 4-microns thick
Acceptable: None
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| TECHONLY | Ambient (preferred) | ||
| Refrigerated | |||
Reject Due To
| Wet/frozen tissue Cytology smears Nonformalin fixed tissue Nonparaffin embedded tissue Noncharged slides ProbeOn slides Snowcoat slides |
Reject |
Day(s) Performed
Monday through Friday
CPT Code Information
88342-Primary
88341-If additional IHC
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| KI67 | Ki-67 (MIB-1) IHC, Tech Only | Order only;no result |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 70793 | Ki-67 (MIB-1) IHC, Tech Only | Bill only; no result |
Secondary ID
70481Clinical 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 does not include pathologist interpretation, only technical performance of the stain. If interpretation is required, order PATHC / Pathology Consultation for a full diagnostic evaluation or second opinion of the case.
The positive and negative controls are verified as showing appropriate immunoreactivity. If a control tissue is not included on the slide, a scanned image of the relevant quality control tissue is available upon request; call 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.
Cautions
Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen dependent. Best practice is for paraffin sections to be cut within 6 weeks.
The charge of glass slides can be affected by environmental factors and subsequently may alter slide staining. Sending unsuitable glass slides can result in inconsistent staining due to poor slide surface chemistry.
Best practices for storage of positively charged slides:
-Minimize time slides are stored after being unpackaged
-Limit exposure to high humidity and heat
-Minimize exposure to plastics
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
6. Magaki S, Hojat SA, Wei B, So A, Yong WH. An introduction to the performance of immunohistochemistry. Methods Mol Biol. 2019;1897:289-298. doi:10.1007/978-1-4939-8935-5_25
Method Description
Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)
Report Available
1 to 3 daysSpecimen Retention Time
Until staining is completeTest 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.Forms
If not ordering electronically, complete, print, and send a Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.