ARUP's Laboratory Test Directory

ERBB2 (HER2/neu) Gene Amplification by Dual in-situ Hybridization : 2007410
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Additional Technical Information
  


Mnemonic: HER2 ISH

Methodology: Dual in situ Hybridization
Performed: Sun-Thu
Reported: 3-5 days
Specimen Required: Collect: 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.

Remarks: 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.

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.

Stability (collection to initiation of testing): Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Reference Interval:
 
Available Separately Components Reference Interval
No HER2 by Dual In Situ Hybridization Nonamplified: HER2/CEP17 less than 2.0
Amplified: HER2/CEP17 greater than or equal to 2.0
No HER2/CEP17 RATIO By Report
No HER2 copy per cell By report
No Percent of Amplified Invasive Tumor Genetic heterogeneity (GH) exists when there are more than 5 percent but less than 50 percent of infiltrating tumor cells with a ratio greater than or equal to 2.0.

Interpretive Data: Refer to report
CPT Code(s): 88368 x2