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HelpTest Code ALKLC Anaplastic Lymphoma Kinase for Lung Cancer, Immunohistochemistry
Shipping Instructions
Attach the green "Attention Pathology" address label (T498) to the outside of the transport container before putting into the courier mailer.
Necessary Information
A pathology/diagnostic report and a brief history, including primary site of neoplasm, are required.
Specimen Required
Specimen Type: Tissue
Supplies: Pathology Packaging Kit (T554)
Submit:
Formalin-fixed, paraffin-embedded tissue block
OR
3 Unstained glass, "positively charged" slides with 4-microns formalin-fixed, paraffin-embedded tissue
Additional Information: One slide will be stained with hematoxylin and eosin and returned.
Secondary ID
615713Useful For
Identification of anaplastic lymphoma kinase (ALK) expression
Prediction of tumor response to targeted therapy of non-small cell lung carcinomas.
Method Name
Immunohistochemistry (IHC)
Reporting Name
ALK for Lung Cancer IHCSpecimen Type
SpecialSpecimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Special | Ambient (preferred) | |
| Refrigerated | ||
Reject Due To
| Wet/frozen tissue | Reject |
| Decalcified paraffin embedded tissue | Reject |
| Cytology smears | Reject |
| Nonformalin fixed tissue including alcohol-formalin-acetic acid (AFA), 95% ethanol, PREFER fixatives or zinc formalin | Reject |
| Nonparaffin embedded tissue | Reject |
| Noncharged slides | Reject |
| ProbeOn slides | Reject |
| Snowcoat slides | Reject |
Clinical Information
A subset of lung cancers, specifically adenocarcinomas, harbor anaplastic lymphoma kinase (ALK) rearrangements. Expression of ALK in tumor cells can be used as a surrogate marker for ALK rearrangement. The presence of ALK rearrangement (ALK protein expression) is a predictive biomarker for response to ALK tyrosine kinase inhibitors.
Interpretation
This test, when not accompanied by a pathology consultation request, will be answered as either positive or negative. If additional interpretation or analysis is needed, request PATHC / Pathology Consultation along with this test.
Cautions
This test has been validated for non-decalcified paraffin-embedded tissue specimens fixed in 10% neutral buffered formalin at Mayo Clinic in Rochester, Minnesota. Specimens are recommended to be placed in formalin within 1 hour of acquisition and fixed between 6 hours and 48 hours. This assay has not been validated on tissue or cellblocks subjected to alternative fixatives or decalcification.
Age of a cut paraffin section can affect immunoreactivity. Stability thresholds vary widely among published literature and are antigen dependent. Best practice is for paraffin sections to be cut within 6 weeks.
The charge of glass slides can be affected by environmental factors and subsequently may alter slide staining. Sending unsuitable glass slides can result in inconsistent staining due to poor slide surface chemistry.
Best practices for storage of positively charged slides:
-Minimize time slides are stored after being unpackaged
-Limit exposure to high humidity and heat
-Minimize exposure to plastics
Clinical Reference
1. Hutarew G, Hauser-Kronberger C, Strasser F, Llenos IC, Dietze O. Immunohistochemistry as a screening tool for ALK rearrangement in NSCLC: evaluation of five different ALK antibody clones and ALK FISH. Histopathology. 2014;65(3):398-407
2. Stein H, Foss HD, Durkop H, et al. CD30(+) anaplastic large cell lymphoma: a review of its histopathologic, genetic, and clinical features. Blood. 2000;96(12):3681-3695
3. Yi ES, Boland JM, Maleszewski JJ, et al. Correlation of IHC and FISH for ALK gene rearrangement in non-small cell lung carcinoma: IHC score algorithm for FISH. J Thorac Oncol. 2011;6(3):459-465
Method Description
Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
5 to 7 daysSpecimen Retention Time
Until reportedPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
88342-Primary
88341-If additional IHC
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| ALKLC | ALK for Lung Cancer IHC | 47303-3 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 615714 | Interpretation | 59465-5 |
| 615715 | Participated in the Interpretation | No LOINC Needed |
| 615716 | Report electronically signed by | 19139-5 |
| 615717 | Material Received | 81178-6 |
| 615718 | Disclaimer | 62364-5 |
| 615719 | Case Number | 80398-1 |
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| IHPCA | IHC Additional | No | No |
| IHPCI | IHC Initial | No | No |
Testing Algorithm
For the initial immunohistochemistry (IHC) stain performed, the appropriate bill-only test ID will be added and charged (IHPCI). For each additional IHC stain performed, an additional bill-only test ID will be added and charged (IHPCA).
Forms
If not ordering electronically, complete, print, and send a Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763) with the specimen.