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Mayo Test ID P53 p53 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


Specimen Type: Tissue

Supplies: Immunostain Technical Only Envelope (T693)

Container/Tube: Immunostain Technical Only Envelope

Preferred:

-Formalin-fixed, paraffin-embedded tissue block

OR

-2 Unstained, positively charged glass slides (25- x 75- x 1-mm) per test ordered; sections 4-microns thick

Acceptable: None


Useful For

Aiding in the identification of neoplastic cells

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

p53 IHC, Tech Only

Specimen Type

TECHONLY

Specimen 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
Snowcoat slides		 Reject

Clinical Information

p53 is a tumor-suppressor protein. Genetic events (variant and deletion) that affect both P53 alleles can lead to loss of cell cycle control in the setting of DNA damage, resulting in genetic instability and neoplastic transformation. Altered p53 also has a prolonged half-life compared to wildtype p53 and, thus, accumulates in the nucleus and can be detected by immunohistochemistry. Abnormalities of the P53 gene are one of the most common genetic changes associated with cancer and can be found in a wide variety of tumor types, where they are generally associated with a worse prognosis. The p53 protein can be readily detected in a subset of cancers of the colon, stomach, bladder, breast, lung, and testes and in melanoma and lymphoma.

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.

 

The charge of glass slides can be affected by environmental factors and subsequently may alter slide staining. Sending unsuitable glass slides can result in inconsistent staining due to poor slide surface chemistry.

 

Best practices for storage of positively charged slides:

-Minimize time slides are stored after being unpackaged

-Limit exposure to high humidity and heat

-Minimize exposure to plastics

Clinical Reference

1. Magaki S, Hojat SA, Wei B, So A, Yong WH. An Introduction to the Performance of Immunohistochemistry. Methods Mol Biol. 2019;1897:289-298

2. Camelo-Piragua S, Jansen M, Ganguly A, et al. A sensitive and specific diagnostic panel to distinguish diffuse astrocytoma from astrocytosis: chromosome 7 gain with mutant isocitrate dehydrogenase 1 and p53. J Neuropathol Exp Neurol. 2011;70(2):110-115

3. Klemi PJ, Pylkkanen L, Kiilholma P, Kurvinen K, Joensuu H. p53 protein detected by immunohistochemistry as a prognostic factor in patients with epithelial ovarian carcinoma. Cancer. 1995;76(7):1201-12084. Mayall FG, Goddard H, Gibbs AR. p53 immunostaining in the distinction between benign and malignant mesothelial proliferations using formalin-fixed paraffin sections. J Pathol. 1992;168(4):377-3815. van den Berg FM, Baas IO, Polak MM, Offerhaus GJ. Detection of p53 overexpression in routinely paraffin-embedded tissue of human carcinomas using a novel target unmasking fluid. Am J Pathol. 1993;142(2):381-385

6. Zarei S, Wang Y, Jenkins SM, Voss JS, Kerr SE, Bell DA. Clinicopathologic, Immunohistochemical, and Molecular Characteristics of Ovarian Serous Carcinoma With Mixed Morphologic Features of High-grade and Low-grade Serous Carcinoma. Am J Surg Pathol. 2020;44(3):316-328

7. Magaki S, Hojat SA, Wei B, So A, Yong WH. An introduction to the performance of immunohistochemistry. Methods Mol Biol. 2019;1897:289-298. doi:10.1007/978-1-4939-8935-5_25

Method Description

Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

Specimen 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
P53 p53 IHC, Tech Only Order only;no result

 

Result ID Test Result Name Result LOINC Value
70840 p53 IHC, Tech Only Bill only; no result