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Test Code GCDF GCDFP-15 Immunostain, Technical Component Only


Advisory Information


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


Supplies: Immunostain Technical Only Envelope (T693)

Specimen Type: Tissue

Container/Tube: Immunostain Technical Only Envelope (T693)

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

Acceptable: Formalin-fixed, paraffin-embedded (FFPE) tissue block


Secondary ID

70441

Useful For

Aids in the identification of extramammary Paget disease, carcinomas of the salivary glands, sweat glands, and prostate

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

Reporting Name

GCDFP-15 IHC, Tech Only

Specimen Type

TECHONLY

Specimen Stability Information

Specimen Type Temperature Time
TECHONLY Ambient (preferred)
  Refrigerated 

Reject Due To

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

Wet/frozen tissue, Cytology smears, Nonformalin fixed tissue, Nonparaffin embedded tissue, Noncharged slides, ProbeOn slides

Clinical Information

Immunohistochemical staining with the monoclonal antibody GCDFP-15 produces diffuse, granular cytoplasmic staining in apocrine sweat glands, normal breast epithelial cells, and breast carcinoma malignant cells. Other neoplasms expressing GCDFP-15 are extramammary Paget disease and carcinomas of the salivary glands, sweat glands, and prostate. A heterogeneous staining pattern, often with paranuclear enhancement, is usually obtained in breast carcinoma.

Interpretation

This test includes only technical performance of the stain (no pathologist interpretation is performed). Mayo Clinic cannot provide an interpretation of tech only stains outside the context of a pathology consultation. If an interpretation is needed, refer to test code PATHC / Pathology Consultation for a full diagnostic evaluation or second opinion of the case. All material associated with the case is required. Additional specific stains may be requested as part of the pathology consultation, and will be performed as necessary at the discretion of the Mayo pathologist.

 

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. Contact 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. Bhargava R, Beriwal S, Dabbs DJ: Mammaglobin vs. GCDFP-15. An immunohistologic validation survey for sensitivity and specificity. Am J Clin Pathol 2007;127:103-113

2. Mazoujian G, Pinkus GS, Haagensen DE Jr: Immunohistochemistry of a gross cystic disease fluid protein (GCDFP-15) of the breast. A marker of apocrine epithelium and breast carcinomas with apocrine features. Am J Pathol 1983;110(2):105-112

3. Wick MR, Lillemoe TJ, Coland GT, et al: Gross cystic disease fluid protein-15 as a marker for breast cancer: Immunohistochemical analysis of 690 human neoplasms and comparison with alpha-lactalbumin. Human Pathology 1989;20(3):281-287

4. Yang M, Nonaka D: A study of immunohistochemical differential expression in pulmonary and mammary carcinomas. Modern Pathology 2010;23:654-661

Day(s) and Time(s) Performed

Monday through Friday

Analytic Time

1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been cleared or approved by the U.S. 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

Result ID Test Result Name Result LOINC Value
70754 GCDFP-15 IHC, Tech Only No LOINC Needed

Forms

If not ordering electronically, complete, print, and send an Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request Form (T763) (http://www.mayomedicallaboratories.com/it-mmfiles/ihc-and-ish-stain-request-form-mc0767-09a.pdf).