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HelpTest Code P16 p16 (INK4a/CDKN2A) Immunostain, Technical Component Only
Ordering 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
Supplies: Immunostain Technical Only Envelope (T693)
Specimen Type: Tissue
Container/Tube: Immunostain Technical Only Envelope
Preferred: 2 Unstained positively charged glass slide (25- x 75- x 1-mm) per test ordered; sections 4-microns thick
Acceptable: Formalin-fixed, paraffin-embedded tissue block
Useful For
Aids in the identification of human papilloma virus infection
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 (IHC)
Reporting Name
p16 (INK4a/CDKN2A) IHC, Tech OnlySpecimen Type
TECHONLYSpecimen 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 |
Reject |
Clinical Information
p16 (INK4a/CDKN2A) is a cell cycle regulatory protein that is overexpressed in cervical dysplasia related to human papilloma virus (HPV) infection. Nuclear and cytoplasmic staining is seen in dysplastic squamous cervical epithelial cells infected with HPV but not in normal cells. A subset of pancreatic islet cells and dendritic cells show expression of p16 and can serve as positive control.
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.
Method Description
Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
1 to 3 daysSpecimen Retention Time
Until staining is complete.Performing Laboratory
Mayo Clinic Laboratories in Rochester
Test 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.CPT Code Information
88342-TC, primary
88341-TC, if additional IHC
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| P16 | p16 (INK4a/CDKN2A) IHC, Tech Only | Order only;no result |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 70836 | p16 (INK4a/CDKN2A) IHC, Tech Only | Bill only; no result |
Forms
If not ordering electronically, complete, print, and send a Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.