ERBB2 (HER2/neu) (4B5) by Immunohistochemistry, Tissue with Reflex to FISH if 2+
2002217
 
Additional Technical InformationAdditional Technical Information
Immunohistochemistry Stain Form Recommended  (ARUP form #32978)Immunohistochemistry Stain Form Recommended (ARUP form #32978)
Ordering Recommendation
Mnemonic
4B5 2 IP
Methodology
Immunohistochemistry
Performed
Mon-Fri
Reported
1-5 days
Reflexed to ERBB2 FISH (2008603) if 2+, FISH assay will be performed and reported within 4-12 days, if no repeats are required.
New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
 
Collect
Tumor tissue  
Specimen Preparation
Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue within 30 minutes of removal from patient.. Fixative duration: 8-48 hours. Transport tissue block or 10 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)522-2787 (min: 6 slides). If sending precut slides, do not oven bake.  
Storage/Transport Temperature
Room temperature or refrigerated. Ship in cooled container during summer months.  
Unacceptable Conditions
Specimens with fixation delayed for more than 30 minutes. Specimens fixed in any other fixative other than 10 percent neutral buffered formalin. Tissue fixed for less than 8 hours or greater than 48 hours. Cytology specimens fixed in alcohol.  
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. IMMUNOHISTOCHEMISTRY ORDERING AND SUBMISSION DETAILS: Submit electronic request. If you do not have electronic ordering capability, use an ARUP Immunohistochemistry form (#32978) with an ARUP client number. For additional technical details, please contact ARUP Client Services at (800) 522-2787.  
Stability
Ambient: Indefinite; Refrigerated: Indefinite ; Frozen: Unacceptable  
Reference Interval
Interpretive Data
Refer to report.
Note
If ERBB2 (HER2/neu) (4B5) result is 2+, then ERBB2 (HER2/neu) Gene Amplification by FISH will be added. Additional charges apply.
CPT Code(s)
88360; if reflexed, add 88368 x2
Components
Component Test Code*Component Chart Name
0049171Homogenous Pattern
0049184Intensity of Staining
0049188Percent of Cells/Circumferential
2002219ERBB2(HER2/neu)(4B5) Comments
2002518ERBB2(HER2/neu)(4B5)Rflx to FISH if 2+
2009596Homogeneous dark circumferential pattern
2009597Uniformity of staining
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, contact interface support at interface.support@aruplab.com.
Cross References
  • 4B5
  • 4B5 Reflex
  • c-erbB2 (4B5) IHC, 2+ FISH reflex
  • ERBB2 (4B5) IHC, 2+ FISH reflex
  • HER-2/neu (4B5) IHC, 2+ FISH reflex
  • PathVysion FISH Reflex