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Test Code CLAUD Claudin-1 Immunostain, Technical Component Only

Reporting Name

Claudin-1 IHC, Tech Only

Useful For

Identification of a number of different soft tissue and epithelial neoplasms

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)

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 "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


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
CLAUD Claudin-1 IHC, Tech Only Order only;no result

 

Result ID Test Result Name Result LOINC Value
70716 Claudin-1 IHC, Tech Only Bill only; no result

Secondary ID

70403

Clinical Information

Claudin proteins are a family of tight junction-associated proteins that prevent leakage of ions, water, etc between cells. Differential expression of claudin proteins is seen in various epithelial cell types. Strong expression of claudin-1 is seen on squamous epithelial cells of the skin. Claudin-1 may have reduced expression in invasive versus benign breast lesions. In the diagnostic setting, 30% to 50% of soft tissue and intramucosal intestinal perineuriomas are positive for claudin-1. Gastric intestinal-type adenocarcinoma shows more frequent claudin-1 expression than diffuse gastric carcinomas.

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. Katzka DA, Tadi R, Smyrk TC, et al. Effects of topical steroids on tight junction proteins and spongiosis in esophageal epithelia of patients with eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2014;12(11):1824-9.e1. doi:10.1016/j.cgh.2014.02.039

2. Bhat AA, Syed N, Therachiyil L, et al. Claudin-1, a double-edged sword in cancer. Int J Mol Sci. 2020;21(2):569. doi:10.3390/ijms21020569

3. Moldvay J, Fabian K, Jackel M, et al. Claudin-1 protein expression Is a good prognostic factor in non-small cell lung cancer, but only in squamous cell carcinoma cases. Pathol Oncol Res. 2017;23(1):151-156. doi:10.1007/s12253-016-0115-0

4. 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)

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.