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Test Code P16 p16 (INK4a/CDKN2A) 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 slide (25- x 75- x 1-mm) per test ordered; sections 4-microns thick.

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

Reporting Name

p16 (INK4a/CDKN2A) IHC, Tech Only

Specimen Type

TECHONLY

Specimen Stability Information

Specimen Type Temperature Time
TECHONLY Ambient (preferred)
  Refrigerated 

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.

Day(s) and Time(s) Performed

Monday through Friday

Analytic Time

1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were 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
70836 p16 (INK4a/CDKN2A) IHC, Tech Only No LOINC Needed

NY State Approved

Yes