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Immunohistochemistry Stain Form Recommended (ARUP form #32978)

Ordering Recommendation

Determine eligibility for tyrosine kinase inhibitor (TKI) therapy, primarily in individuals with pulmonary adenocarcinomas. Detects ALK fusion proteins.

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 specimen. Protect paraffin block and/or slides from excessive heat. 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) 522-2787. (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 fixed in any fixative other than 10 percent neutral buffered formalin. Decalcified specimens.

Remarks

This test code includes pathologist interpretation. Include surgical pathology report. IMMUNOHISTOCHEMISTRY ORDERING AND SUBMISSION DETAILS: Submit electronic request. If you do not have electronic ordering capability, use an ARUP Immunohistochemistry Stain 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 (IHC)

Performed

Mon-Fri

Reported

1-5 days

Reference Interval

Interpretive Data

Refer to report.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

Note

This test includes pathologist interpretation of results. Include surgical pathology report with specimen submitted for testing. Indicate tissue site on requisition.

Hotline History

N/A

CPT Codes

88342

Components

Component Test Code* Component Chart Name LOINC
2007325 ALK(D5F3) by IHC Reference Number 94736-6
2007327 ALK(D5F3) by IHC Result 47303-3
3003119 ALK 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

  • ALK D5F3 antibody staining
  • ALK D5F3 staining
  • ALK rearrangement by IHC
  • ALK rearrangement staining
ALK (D5F3) with Interpretation by Immunohistochemistry