ARUP's Laboratory Test Directory

C-erb B-2 (HER-2/neu) with Reflex to HER-2/neu by FISH if 2+ or 3+ : 0049168

Mnemonic: CERB23 IP

Methodology: Immunohistochemistry
Performed: Mon-Fri
Reported: 1-5 days
Reflexed to HER2FISH (0049218) as requested, FISH assay will be performed and reported within 4-12 days, if no repeats are required.
Specimen Required: 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
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.
Note: A 2+ or 3+ result will be confirmed by FISH testing. FISH results should be considered definitive.

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
 
 

 

 

 
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