Test Catalog

Test Id : MITAN

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Mitotane, Plasma

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Overview

Test Catalog

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

Assessing compliance or making dosage adjustments for mitotane

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

Gas Chromatography Mass Spectrometry (GC-MS) Confirmation with Quantitation

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

Mitotane, P

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

Lysodren

Specimen Type
Describes the specimen type validated for testing

Plasma Na Heparin

Shipping Instructions

Ship specimen refrigerated.

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

Collection Container/Tube: Plain, green-top tube (sodium heparin). Lithium Heparin and Gel tubes are not acceptable.

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot plasma into plastic vial within 2 hours of collection.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.5 mL

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

Hemolysis Mild OK; Gross OK
Thawing** Warm OK; Cold OK
Lipemia Mild OK; Gross Reject
Icterus Mild, OK; Gross OK
List other reasons for rejection Serum gel tube, Plasma Gel Tube

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
Plasma Na Heparin Refrigerated (preferred) 21 days
Frozen 28 days
Ambient 72 hours

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

Assessing compliance or making dosage adjustments for mitotane

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

This test is intended for the use of therapeutic monitoring of the drug mitotane in patients being treated for adrenal carcinoma. Guidelines suggest monitoring mitotane serum/plasma levels every 2 to 3 weeks for the first 3 months. After reaching a plateau, the interval can be extended (eg, every 6 weeks). Mitotane is a key drug for the treatment of adrenal cortical carcinoma. Due to its narrow therapeutic window (14 to 20 mcg/mL), monitoring its concentration is crucially important.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Therapeutic: 14-20 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

In the literature when mitotane is used to treat adrenocortical carcinoma, the maximum benefit is seen when plasma mitotane concentrations are between 14-20 mcg/mL.

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

No significant cautionary statements

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

1. Feliu C, Cazaubon Y, Guillemin H, et al. Therapeutic drug monitoring of mitotane: Analytical assay and patient follow-up. Biomed Chromatogr. 2017;31(11):10.1002/bmc.3993. doi:10.1002/bmc.3993

2. Ando M, Hirabatake M, Yasui H, Fukushima S, Sugioka N, Hashida T. A simplified method for therapeutic drug monitoring of mitotane by gas chromatography-electron ionization-mass spectrometry. Biomed Chromatogr. 2020;34(3):e4776. doi:10.1002/bmc.4776

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

After protein precipitation, mitotane is analyzed by gas chromatography with mass spectrometry.(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.

Tuesday, Thursday

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.

2 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

14 days

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.

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  • 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.

80299

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
MITAN Mitotane, P 13626-7
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.
621811 Mitotane, P 13626-7

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 | 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

Test Update Resources

Change Type Effective Date
New Test 2025-01-09