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Test Code KRT34 Keratin (34BE12) Immunostain, Technical Component Only

Reporting Name

Keratin (34BE12) IHC, Tech Only

Useful For

Identification of cells expressing high-molecular-weight cytokeratin

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)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

TECHONLY


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


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


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 

Day(s) Performed

Monday through Friday

CPT Code Information

88342-TC, primary

88341-TC, if additional IHC

LOINC Code Information

Test ID Test Order Name Order LOINC Value
KRT34 Keratin (34BE12) IHC, Tech Only Order only;no result

 

Result ID Test Result Name Result LOINC Value
70804 Keratin (34BE12) IHC, Tech Only Bill only; no result

Secondary ID

70492

Clinical Information

Keratin 34 beta E12 (sometimes referred to as Keratin 903) is a monoclonal antibody that reacts with high-molecular-weight cytokeratin. In normal prostate, reactivity for keratin 34BE12 can be seen in the basal layer of prostatic glands in a membranous/cytoplasmic pattern. It is most useful as a basal cell-specific marker in the prostate, and shows loss of staining around glands of prostate cancer, which do not have a basal cell layer.

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 and documentation is retained at Mayo Clinic Rochester. 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. Brimo F, Epstein JI: Immunohistochemical pitfalls in prostate pathology. Hum Pathol. 2012 Mar;43(3):313-324

2. Hameed O, Humphrey PA: Immunohistochemistry in the diagnosis of minimal prostate cancer. Current Diagn Pathol. 2006 Aug;12(4):279-291
3. Martens MB, Keller JH: Routine immunohistochemical staining for high-molecular weight cytokeratin 34-beta and alpha-methylacyl CoA racemase (P504S) in postirradiation prostate biopsies. Mod Pathol. 2006 Feb;19(2):287-290
4. Varma M, Morgan M, Amin MB, Wozniak S, Jasani B: High molecular weight cytokeratin antibody (clone 34beta12): a sensitive marker for differentiation of high-grade invasive urothelial carcinoma from prostate cancer. Histopathology. 2003 Feb;4292):167-172

Method Description

Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)

Report Available

1 to 3 days

Specimen Retention Time

Until staining is complete.

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.

Forms

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