HER2 Immunostain, Technical Component Only
Use
The test is useful for the qualitative detection of HER2 protein overexpression in a diagnostic setting in formalin-fixed paraffin-embedded tissue sections. HER2 protein is a membrane receptor tyrosine kinase and is a normal component expressed by various epithelial cell types.
Special Instructions
Not provided.
Limitations
The test does not include pathologist interpretation, only a technical performance of the stain. The stability of the paraffin section affects immunoreactivity. Best practice is to have the paraffin sections cut within 6 weeks. Additionally, unsuitable glass slides or poor slide surface chemistry may result in inconsistent staining.
FDA ApprovedNew York Approved
Methodology
Immunoassay (IHC)
Biomarkers
LOINC Codes
- Order only;no result
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Tissue (FFPE)
Volume
Not provided
Minimum Volume
Not provided
Container
Immunostain Technical Only Envelope
Collection Instructions
Submit 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.
Causes for Rejection
Wet/frozen tissue, nonformalin fixed tissue, nonparaffin embedded tissue, noncharged slides, ProbeOn slides, Snowcoat slides.