ARUP's Laboratory Test Directory
| 0049164: C-erb B-2 (HER-2/neu) Tissue Assay, Paraffin |
| Test Mnemonic: CERBIP | |
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Methodology: Immunohistochemistry
Performed: Mon-Fri Reported: 1-5 days |
| Specimen Required: | |
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Collect: Tumor tissue.
Transport: Paraffin-embedded, formalin-fixed tissue block enriched with tumor at 20-25°C. Protect paraffin block from excessive heat. Ship in a cooled container during summer months. Include surgical pathology report. Unacceptable Conditions: Paraffin block with no tumor tissue remaining. Samples fixed in formalin substitute. Stability: Ambient: Indefinitely; Refrigerated: Acceptable; Frozen: Unacceptable |
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| 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:
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| Interpretive Data: | |
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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 indicator). To order these tests, refer to HercepTest® Tissue Assay, Paraffin (0049174) or HER-2/neu by FISH (PathVysion™ HER-2) (0049218). |
| CPT Code(s): | |
| 88360 |