Reference Interval:
These results are given as 0 to 3+ with the following definitions and interpretations:
| Grade
| Interpretation
| Microscopic Finding
| | 0
| Negative
| No staining is observed in invasive tumor cells.
| | 1+
| Negative
| Weak, incomplete membrane staining in any proportion of invasive tumor cells, or weak, complete membrane staining in less than 10% of cells.
| | 2+
| Equivocal
| Complete membrane staining that is nonuniform or weak but with obvious circumferential distribution in at least 10% of cells, or intense complete membrane staining in 30% or less of tumor cells.
| | 3+
| Positive
| Uniform intense membrane staining of more than 30% of invasive tumor cells.
| |
|
| Interpretive Data: |
The results of the HercepTest® by DAKO are interpreted in a semi-quantitative manner. Assay is performed on paraffin-embedded, formalin-fixed tissue. Antibody clone is polyclonal and the detection system is LSAB.
ARUP Laboratories uses the ASCO/CAP criteria for interpretation of HER2 protein expression. Positive cases are those with uniform intense membrane staining of more than 30% of invasive tumor cell (Score 3+). Negative cases are defined as no staining (Score 0) or weak, incomplete membrane staining in any proportion of invasive tumor cells, or weak, complete membrane staining in less than 10% of cells (Score 1). Equivocal cases are those with complete membrane staining that is nonuniform or weak but with obvious circumferential distribution in at least 10% of cells, or intense complete membrane staining in 30% or less of tumor cells (Score 2).
For more information refer to the ASCO/CAP guidelines found at http://www.jco.org
|
| Note: |
If HercepTest result is 2+ or 3+, then HER-2/neu by FISH will be added.
|
| CPT Code(s): |
88360, if reflexed add 88368 x2
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