Test Catalog

Test Id : ALKLC

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Anaplastic Lymphoma Kinase for Lung Cancer, Immunohistochemistry

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Identification of anaplastic lymphoma kinase overexpression

 

Diagnosis of inflammatory myofibroblastic tumor, anaplastic large-cell lymphoma, and for targeted therapy of lung adenocarcinoma

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
IHPCA IHC Additional No No
IHPCI IHC Initial No No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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).

Method Name
A short description of the method used to perform the test

Immunohistochemistry (IHC)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

ALK for Lung Cancer IHC

Aliases
Lists additional common names for a test, as an aid in searching

ALK

ALKLC

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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).

Specimen Type
Describes the specimen type validated for testing

Special

Shipping Instructions

Attach the green pathology address label included in the kit to the outside of the transport container.

Necessary Information

A pathology/diagnostic report and a brief history, including primary site of neoplasm, are required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Pathology Packaging Kit (T554)

Specimen Type: 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.

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Wet/frozen tissue
Cytology smears
Nonformalin fixed tissue
Nonparaffin embedded tissue
Noncharged slides
ProbeOn slides 		Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Special Ambient (preferred)
Refrigerated

Useful For
Suggests clinical disorders or settings where the test may be helpful

Identification of anaplastic lymphoma kinase overexpression

 

Diagnosis of inflammatory myofibroblastic tumor, anaplastic large-cell lymphoma, and for targeted therapy of lung adenocarcinoma

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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).

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

A subset of anaplastic large-cell lymphomas overexpresses anaplastic lymphoma kinase (ALK-1) protein, resulting from a translocation involving the ALK1 gene. The abnormal ALK-1 expression can be in a nuclear or cytoplasmic distribution. Overexpression of ALK-1 protein is also useful for targeted therapy in lung adenocarcinoma and in the diagnosis of inflammatory myofibroblastic tumor. In normal tissue ALK-1 is negative.

Interpretation
Provides information to assist in interpretation of the test results

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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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 Sept;65(3):398-407

2. Stein H, Foss H, Durkop H, et al: CD30(+) anaplastic large cell lymphoma: a review of its histopathologic, genetic, and clinical features. Blood. 2000 Dec;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 Mar;6(3):459-465

Method Description
Describes how the test is performed and provides a method-specific reference

Immunohistochemistry on sections of paraffin-embedded tissue.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

5 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Until reported

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

88342-Primary

88341-If additional IHC

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
ALKLC ALK for Lung Cancer IHC 47303-3
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
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

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports