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Test ID CLDN4 Claudin-4 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

Distinguishing carcinoma from mesothelioma and sarcoma

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

Claudin-4 IHC, Tech Only

Specimen Type

TECHONLY

Specimen Stability Information

Specimen Type Temperature Time Special Container
TECHONLY Ambient (preferred)
  Refrigerated 

Clinical Information

Claudin-4 is a component of tight junction strands and is expressed on the membrane of cells of epithelial origin.

 

Claudin-4 has been shown to distinguish carcinoma from mesothelioma and carcinoma from sarcoma.

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.

Clinical Reference

1. Jo VY, Cibas ES, Pinkus GS. Claudin-4 immunohistochemistry is highly effective in distinguishing adenocarcinoma from malignant mesothelioma in effusion cytology. Cancer Cytopathol. 2014;122(4):299-306

2. Ohta Y, Sasaki Y, Saito M, et al. Claudin-4 as a marker for distinguishing malignant mesothelioma from lung carcinoma and serous adenocarcinoma. Int J Surg Pathol. 2013;21(5):493-501

3. Ordonez NG. Value of claudin-4 immunostaining in the diagnosis of mesothelioma. Am J Clin Pathol. 2013;139(5):611-619

4. Schaefer IM, Agaimy A, Fletcher CD, Hornick JL. Claudin-4 expression distinguishes SWI/SNF complex-deficient undifferentiated carcinomas from sarcomas. Mod Pathol. 2017;30(4):539-548

5. 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

Day(s) Performed

Monday through Friday

Report Available

1 to 3 days

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CLDN4 Claudin-4 IHC, Tech Only Order only;no result

 

Result ID Test Result Name Result LOINC Value
607335 Claudin-4 IHC, Tech Only Bill only; no result

Forms

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

Mayo Clinic Laboratories | IHC Catalog Additional Information:

mcl-ihc