Ki-67 with Interpretation by Immunohistochemistry

Also known as: KI-67 IP

Clinical Use

Use

The Ki-67 with Interpretation by Immunohistochemistry test is used to estimate the growth fraction of a tumor cell population. The Ki-67 antigen is expressed in all phases of the active cell cycle except for the resting phase (G0), making it a useful marker for determining the proliferation rate of tumor cells. This test can provide valuable prognostic information in a variety of cancers, as higher proliferation rates often correlate with more aggressive tumors. Results are obtained through manual interpretation of stained tissue sections, and the percentage of tumor cells staining is calculated and reported.

Special Instructions

Not provided.

Limitations

This test was developed and its performance characteristics determined by ARUP Laboratories but has not been cleared or approved by the US Food and Drug Administration. It is performed in a CLIA certified laboratory for clinical purposes. Interpretation of results should be made in conjunction with other clinical and pathological data. Variability in fixation, staining, and interpretation can affect results; only formalin-fixed, paraffin-embedded tumor tissue is acceptable.

Test Details

New York Approved

Methodology

Immunoassay (IHC)

Biomarkers

Ki-67

Protein

Percent of Tumor Staining

Expression • Categorical (e.g., Positive / Negative / Indeterminate)

LOINC Codes

Result Codes

94736-6 - Tissue block ID Spec
55229-9 - Immune stain study
31208-2 - Specimen source

Result Turnaround Time

1-5 days

Specimen

Tumor Tissue (FFPE)

Volume

Not provided

Minimum Volume

Not provided

Container

Tissue transport kit

Collection Instructions

Collect tumor tissue and fix in 10 percent neutral buffered formalin. Embed in paraffin and transport tissue block or unstained slides in a tissue transport kit. Do not oven bake slides if sending precut slides. Use ARUP supply #47808 for transport.

Storage Instructions

Store at room temperature. Refrigerated storage is also acceptable. Ship in cooled container during summer months.

Causes for Rejection

Paraffin block with no tumor tissue remaining, specimens fixed in any fixative other than 10 percent neutral buffered formalin, decalcified specimens.