Icon

Immunohistochemistry Stain Form Recommended (ARUP form #32978)

Ordering Recommendation

Aid in prediction of response to HER2-directed therapy in patients with breast carcinoma or gastroesophageal adenocarcinoma. Refer to ARUP Immunohistochemistry Stain Offerings brochure at www.aruplab.com/ap/resources.

New York DOH Approval Status

This test is New York state 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: 6-72 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

Paraffin block with no tumor tissue remaining. Specimens with fixation delayed for more than one hour. Specimens fixed in any other fixative other than 10 percent neutral buffered formalin. Tissue fixed for less than 6 hours or greater than 72 hours. Decalcified specimens.

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.
If multiple specimens (blocks or slides) are sent to ARUP, they must be accompanied by one of the following: an order comment indicating that the ARUP pathologist should choose the specimen most appropriate for testing (e.g., "Choose best block"), or individual orders for each sample submitted. A Pathologist Block Selection Fee (ARUP test code 3002076) will be added to orders that utilize the first option. If multiple specimens are sent to ARUP without a request for pathologist block/slide selection or individual orders, they will be held until clarification is provided.

Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Methodology

Immunohistochemistry

Performed

Mon-Fri

Reported

1-5 days
If reflexed, add 3-7 days.

Reference Interval

Interpretive Data

Refer to report.

Compliance Category

FDA

Note

If ERBB2 (HercepTest) result is 2+, then ERBB2 (HER2/neu) Gene Amplification by FISH, Tissue will be added. Additional charges apply.

Hotline History

N/A

CPT Codes

88360; if reflexed, add 88377

Components

Component Test Code* Component Chart Name LOINC
0049171 Homogenous Pattern
0049184 Intensity of Staining
0049188 Percent of Cells/Circumferential
0049244 Fixative Used
0049246 Time from Bx to Fixative
0049247 Duration of Fixation
0049520 ERBB2(HercepTest)Rflx to FISH if 2+ 18474-7
3005643 Sample Adequacy
3005644 HER2 Reference Number 94736-6
3005645 HER2 Tissue Source 31208-2
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • 2+ FISH reflex
  • c-erbB2 Hercept IHC
  • ERBB2 Hercept IHC
  • HER-2/neu Hercept IHC
  • HER2 (ERBB2 (HercepTest(R)) Tissue Assay, Paraffin) with Reflex to FISH if 2+
  • HER2 IHC (ERBB2 (HercepTest(R)) Tissue Assay, Paraffin) with Reflex to FISH if 2+
  • Herceptin (ERBB2 (HercepTest(R)) Tissue Assay, Paraffin) with Reflex to FISH if 2+
ERBB2 (HER2/neu) (HercepTest) by Immunohistochemistry, Tissue with Reflex to FISH if 2+