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HelpTest Code HER2I HER2 Immunostain, Technical Component Only
Ordering Guidance
This test provides qualitative results only. For semiquantitative assessment of HER2 as a predictive or prognostic marker in the setting of breast cancer, order HERBA / HER2, Breast, Quantitative Immunohistochemistry, Automated with HER2 FISH Reflex or in the setting of gastric esophageal tissues, order HERGM / HER2, Gastric/Esophageal, Semi-Quantitative Immunohistochemistry, Manual and return Mayo-stained tech only HER2 slide along with hematoxylin and eosin-stained slide, or block and 2 unstained slides.
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
Forms
If not ordering electronically, complete, print, and send a Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.
Useful For
Identification of HER2 protein overexpression in formalin-fixed, paraffin-embedded tissue sections
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)
Reporting Name
HER2 IHC, Tech OnlySpecimen Type
TECHONLYSpecimen 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 |
Clinical Information
The human HER2 gene (also known as ERBB2 or NEU) encodes a protein often referred to as HER2 protein or P185(HER2). The HER2 protein is a membrane receptor tyrosine kinase with homology to the epidermal growth factor receptor (EGFR or HER1). The HER2 protein is a normal component expressed by a variety of epithelial cell types.
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; 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.
Cautions
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. Calhoun BC, Collins LC: Predictive markers in breast cancer: an update on ER and HER2 testing and reporting. Semin Diagn Pathol. 2015 Sept;32(5):362-369. doi: 10.1053/j.semdp.2015.02.011
2. Bahreini F, Soltanian AR, Mehdipour P: A meta-analysis on concordance between immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) to detect HER2 gene overexpression in breast cancer. Breast Cancer. 2015 Nov;22(6):615-625. doi: 10.1007/s12282-014-0528-0
3. Wolff AC, Hammond EH, Hicks DG, et al: Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013 Nov;31(31):3997-4013. doi: 10.1200/JCO.2013.50.9984
Method Description
Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
1 to 3 daysSpecimen Retention Time
Until staining is complete.Performing Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
88342-TC, primary
88341-TC, if additional IHC
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| HER2I | HER2 IHC, Tech Only | Order only;no result |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 70770 | HER2 IHC, Tech Only | Bill only; no result |