•Use to confirm equivocal HercepTest or 4B5 immunohistochemistry (IHC) result (2+).
•Preferred alternative to FISH.
- Patient Preparation
- Tumor tissue.
- Specimen Preparation
- Formalin fix (10 percent neutral buffered formalin) specimen no later than 30 minutes after removal from patient and paraffin-embed tissue. Fixative duration: 8-48 hours. Transport tissue block or 5 unstained (3- to 5-micron thick sections), positively charged slides in a tissue transport kit (ARUP supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800)522-5257. (Min: 3 slides) If sending precut slides, do not oven bake.
- Storage/Transport Temperature
- Room temperature. Also acceptable: Refrigerated. Ship in cooled container during summer months.
- Unacceptable Conditions
- Paraffin block with no tumor tissue remaining. Specimens with fixation delayed for more than 30 minutes. Specimens fixed in any other fixative other than 10 percent neutral buffered formalin. Specimens fixed in heavy metal fixatives (B-4 or B-5). Tissue fixed for less than 8 hours or greater than 48 hours. Cytology specimens fixed in alcohol. Frozen specimens. Decalcified specimens.
- Pathology report including tissue source and tumor origin must be submitted. Document time from tissue acquisition to fixation and fixation duration on requisition or enter at time of order.
- Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable
|Component Test Code*||Component Chart Name||LOINC|
|0049219||HER2/ neu:CEP 17 Ratio||49683-6|
|0049243||HER2 - Number of Tumor Cells Counted||19076-9|
|0049261||HER2 - Number of Observers||19099-1|
|2005262||Percent of Amplified Invasive Tumor|
|2005263||Her2 Genetic Heterogeneity|
|2007411||ERBB2 by DUAL ISH Result|
|2007412||CEP17 signals per cell|
|2007413||ERBB2 (HER2) signals per cell|
|2007417||ERBB2 by Dual ISH Comments|
- c-erbB2 Dual ISH
- ERBB2 Dual ISH
- HER-2/neu Dual ISH
- INFORM Dual In-situ Hybridization Probe