Ki-67(MIB-1), Quantitative Immunohistochemistry, Automated
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Determining proliferation of tumor cells in paraffin-embedded tissue blocks from patients diagnosed with breast or prostate carcinoma
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Immunohistochemistry, Automated Quantitation
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Ki-67(MIB-1), Quant IHC, Automated
Automated, Quantitative MIB-1
Proliferation Analysis by Digital Image Analysis (DIA)
Proliferation Analysis by Digital Image Analysis (DIA)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
If being ordered for diagnostic purposes:
Order 5439 Surgical Pathology Consultation and then request the stain.
If being ordered for prognostic purposes:
Preferred: Formalin-fixed, paraffin-embedded tissue block containing invasive or metastatic breast or prostate carcinoma
Acceptable: 2 unstained sections, containing invasive or metastatic breast or prostate carcinoma, on charged slides cut at 4 microns <1 month ago and shipped at ambient temperature. Tissue on the slides should have been fixed in 10% neutral buffered formalin.
Container/Tube: Surgical Pathology Packaging Kit (Supply T554)
1. Submit paraffin-embedded invasive or metastatic breast or prostate carcinoma tissue.
2. Include accompanying pathology report stating the final diagnosis. If not available, a preliminary diagnosis is acceptable only if it refers to invasive or metastatic breast or prostate carcinoma.
3. Attach the green pathology address label included in the kit to the outside of the transport container.
1. Pathologist's name, address, and phone number are required.
2. Paraffin block will be returned with final report.
Forms: If not ordering electronically, submit a Pathology/Cytology Request Form (Supply T246) with the specimen.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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 Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Varies by tumor type; values reported from 0% to 100%
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 the Automated Cellular Imaging System III (ACIS III) was developed and validated in the Molecular Anatomic Pathology Laboratory, Department of Laboratory Medicine and Pathology, Mayo Clinic (see Method Description).
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
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 Provides recommendations for further in-depth reading of a clinical nature
1. Cheng L, Pisansky TM, Sebo TJ, et al: Cell proliferation in prostate cancer patients with lymph node metastasis: a marker for progression. Clin Cancer Res 1999;5:2820-2823
2. Sebo TJ, Cheville JC, Riehle DL, et al: Perineural invasion and MIB-one positivity in addition to Gleason score are significant preoperative predictors of progression after radical retropubic prostatectomy for prostate cancer. Am J Surg Pathol 2002;26(4):431-439
3. Pollack A, DeSilvio M, Khor LY, et al: Ki-67 staining is a strong predictor of distant metastasis and mortality for men with prostate cancer treated with radiotherapy plus androgen deprivation: Radiation Therapy Oncology Group Trial 92-02. J Clin Oncol 2004;22:2133-2140
4. Berney DM, Gopalan A, Kudahetti S, et al: Ki-67 and outcome in clinically localized prostate cancer: analysis of conservatively treated prostate cancer patients from the Trans-Atlantic Prostate Group study. Br J Cancer 2009 Mar 24;100(6):888-893
1. Urruticoechea A, Smith IE, Dowsett M. Proliferation marker Ki-67 in early breast cancer. J Clin Oncol 2005 Oct 1;23(28):7212-7220
2. de Azambuja E, Cardoso F, de Castro G Jr, et al: Ki-67 as prognostic marker in early breast cancer: a meta-analysis of published studies involving 12,155 patients. Br J Cancer 2007 May 21;96(10):1504-1513
Method Description Describes how the test is performed and provides a method-specific reference
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 ACIS III Instrument, which captures digital images of the patient slide. Selection of specific areas within the digitalized image for ACIS III scoring is performed by the operator of the ACIS who measures 10 representative areas of the tumor specimen under a 40X field of view. The nuclear-area staining with Ki-67(MIB-1) is reported as a percentage of the total hematoxylin-stained nuclear area. The slides and test results are then reviewed by a pathologist who provides a final interpretation.(Unpublished Mayo method)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 8 a.m.-5 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Until 1 week after results are reported
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
88361-Morphometric analysis (eg, Her-2/neu, estrogen/progesterone receptor), tumor-immunohistochemistry, quantitative or semiquantitative, each antibody; using computer-assisted technology
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|20281||Ref Path/Phys Address||In Process|
|20286||SP Signing Pathologist:||N/A|
|20287||*Previous Report Follows*||N/A|