Reference Interval:
The results of this assay are interpreted in a semi-quantitative manner. These results are given as 0 to 3+ with the following definitions and interpretations:
| Grade
| Interpretation
| Microscopic Finding
| | 0
| Negative
| No staining is observed or membrane staining is observed in less than 10% of the tumor cells.
| | 1+
| Negative
| Faint or blush staining involving a portion of the circumference of the cytoplasmic membrane in more than 10% of the neoplastic cell population.
| | 2+
| Positive
| Weak but definitive staining of the membrane over 100% of the cytoplasmic circumference in more than 30% of the neoplastic cell population.
| | 3+
| Positive
| Strong positive staining of the membrane over 100% of the cytoplasmic circumference in more than 30% of the neoplastic cell population.
| |
|
| Interpretive Data: |
The immunohistochemical test traditionally used by ARUP for the assessment of HER2/neu appears to have prognostic and predictive significance but is not FDA approved as a prognostic indicator or as a triage test for Herceptin therapy.
The results of this assay are interpreted in a semi-quantitative manner.
Assay is performed on Paraffin-embedded, formalin-fixed tissue. Antibody clone is 3B5 and the detection system is LSAB.
Please refer to Statement B in the Compliance Statements section in the front of the Laboratory Test Directory.
|
| Note: |
ARUP also offers the HercepTest® by DAKO (IHC), and PathVysion™ by Vysis (HER-2/neu by FISH (PathVysion™ HER-2)), which are FDA approved as triage tests for Herceptin therapy (predictive ndicator). To order these tests, refer to HercepTest® Tissue Assay, Paraffin (0049174) or HER-2/neu by FISH (PathVysion™ HER-2) (0049218).
If C-erb B-2 result is 2+ or 3+, then HER-2/neu by FISH will be added.
|
| CPT Code(s): |
88360; if reflexed add 88368 x2
|