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Test Code P16 p16 (INK4a/CDKN2A) Immunostain, Technical Component Only


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

Additional Information:

1. Information on accessing digital images of IHC stains and the manual requisition form can be accessed through this website: www.mayomedicallaboratories.com/test-info/ihc/index.html

2. Clients ordering stains using a manual requisition form will not have access to digital images.

3. Clients wishing to access digital images must place the order for IHC stains electronically. Information regarding digital imaging can be accessed through this website: www.mayomedicallaboratories.com/test-info/ihc/faq.html


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

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 

Reject Due To

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

Wet/frozen tissue
Cytology smears
Nonformalin fixed tissue
Nonparaffin embedded tissue
Noncharged slides
ProbeOn slides

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 includes only technical performance of the stain (no pathologist interpretation is performed). If diagnostic consultation by a pathologist is required order PATHC / Pathology Consultation.

 

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. Contact 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.

Clinical Reference

1. Castle PE: A LASTing impression: incorporating p16 immunohistochemistry into routine diagnosis of cervical neoplasia. Pathol Case Rev 2013;18:154-157

2. Doxtader EE, Katzenstein AL: The relationship between p16 expression and high-risk human papillomavirus infection in squamous cell carcinomas from sites other than uterine cervix: a study of 137 cases. Human Pathol 2012;43:327-332

3. El-Naggar AK, Westra WH: p16 expression as a surrogate marker for HPV-related oropharyngeal carcinoma: a guide for interpretative relevance and consistency. Head Neck 2012;34:459-461

4. Klaes R, Benner A, Friedrich T, et al: p16INK4a immunohistochemistry improves interobserver agreement in the diagnosis of cervical intraepithelial neoplasia. Am J Surg Pathol 2002;26(11):1389-1399

5. Singhi A, Westra WH: Comparison of human papillomavirus in situ hybridization and p16 immunohistochemistry in the detection of human papillomavirus-associated head and neck cancer based on a prospective clinical experience. Cancer 2010;116:2166-2173

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 cleared or approved by the U.S. 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

LOINC Code Information

Result ID Test Result Name Result LOINC Value
70836 p16 (INK4a/CDKN2A) IHC, Tech Only No LOINC Needed