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HelpTest ID GCDF GCDFP-15 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
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 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 (IHC)
Reporting Name
GCDFP-15 IHC, Tech OnlySpecimen Type
TECHONLYSpecimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| TECHONLY | Ambient (preferred) | ||
| Refrigerated | |||
Clinical Information
Immunohistochemical staining with the monoclonal antibody gross cystic disease fluid protein 15 (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 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. Darb-Esfahani S, von Minckwitz G, Denkert C, et al. Gross cystic disease fluid protein 15 (GCDFP-15) expression in breast cancer subtypes. BMC Cancer. 2014;14:546. doi:10.1186/1471-2407-14-546.
2. Huo L, Zhang J, Gilcrease MZ, et al. Gross cystic disease fluid protein-15 and mammaglobin A expression determined by immunohistochemistry is of limited utility in triple-negative breast cancer. Histopathology. 2013;62(2):267-274. doi:10.1111/j.1365-2559.2012.04344.x
3. Wendroth SM, Mentrikoski MJ, Wick MR. GATA3 expression in morphologic subtypes of breast carcinoma: a comparison with gross cystic disease fluid protein 15 and mammaglobin. Ann Diagn Pathol. 2015;19(1):6-9. doi:10.1016/j.anndiagpath.2014.12.001
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
Day(s) Performed
Monday through Friday
Report Available
1 to 3 daysTest 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 |
|---|---|---|
| GCDF | GCDFP-15 IHC, Tech Only | Order only;no result |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 70754 | GCDFP-15 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.
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).
mcl-ihc