Test ID 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 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

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

Forms

If not ordering electronically, complete, print, and send a Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.

Secondary ID

70524

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

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)

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.

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.

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

88342-TC, primary

88341-TC, if additional IHC

NY State Approved

Yes

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