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Test Code PTRIP Prostate Triple (P63/KRT/P504S), 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 high-grade prostatic intraepithelial neoplasia and prostate cancer

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

P63/KRT/P504S 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

The prostate triple assay consists of 3 antibodies P63, HMW KRT (34betaE12), and P504S. This multiplex is used in the diagnosis of high-grade prostatic intraepithelial neoplasia (PIN) and prostate cancer. P63 (nuclear) and HMW KRT (cytoplasmic) are expressed in normal myoepithelial cells that surround the prostatic epithelial cells (detected with 3,3'-diaminobenzidine chromogen). This myoepithelial layer is lost in carcinoma. P504S (cytoplasmic) is abnormally expressed in high-grade PIN and prostate cancer epithelial cells (detected with fast red chromogen).

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.

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 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

88344-TC

LOINC Code Information

Result ID Test Result Name Result LOINC Value
610457 P63/KRT/P504S IHC, Tech Only No LOINC Needed

Forms

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