Test Catalog

Test Id : AMIO

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Amiodarone, Serum

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Overview

Test Catalog

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

Monitoring amiodarone therapy, especially when amiodarone is coadministered with other drugs that may interact

 

Evaluating possible amiodarone toxicity

 

Assessing patient compliance

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

Liquid Chromatography Mass Spectrometry (LC-MS/MS)

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

Amiodarone, S

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

Amiodarone (Cordarone)

Cordarone (Amiodarone)

Desethylamiodarone

Pacerone (Amiodarone Hydrochloride)

Specimen Type
Describes the specimen type validated for testing

Serum Red

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

Collection Container/Tube: Red top (serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Draw blood no sooner than 12 hours (trough value) after last dose or immediately before next scheduled dose.

2. Centrifuge and aliquot serum into plastic vial within 2 hours of collection.

Forms

If not ordering electronically, complete, print, and send a one of the following with the specimen:

-Therapeutics Test Request (T831)

-Cardiovascular Test Request (T724)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

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

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

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
Serum Red Refrigerated (preferred) 28 days
Frozen 28 days
Ambient 24 hours

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

Monitoring amiodarone therapy, especially when amiodarone is coadministered with other drugs that may interact

 

Evaluating possible amiodarone toxicity

 

Assessing patient compliance

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

Amiodarone is an antiarrhythmic agent used to treat life-threatening arrhythmias; it is typically categorized as a Class III drug (antiarrhythmic agents that are potassium channel blockers) but shows several mechanisms of action. The US Food and Drug Administration approved the use of amiodarone for recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia only after demonstrating lack of response to other antiarrhythmics, but more recent studies have shown amiodarone to be the antiarrhythmic agent of choice for many situations, including atrial fibrillation.(1)

 

Amiodarone can be administered orally or intravenously for cardiac rhythm control. It is approximately 95% protein bound in blood, with a volume of distribution of 60 L/kg. Amiodarone elimination is quite prolonged, with a half-life of 26-107 days for oral, chronic dosing. Cytochrome P450 (CYP) 3A4 converts amiodarone to its equally active metabolite, N-desethylamiodarone (DEA), which displays very similar pharmacokinetics and serum concentrations compared with the parent drug.(2) Current therapeutic ranges are based solely on amiodarone, but most individuals will have roughly equivalent concentrations of DEA at steady state.(3)

 

Numerous side effects have been associated with amiodarone. The most common adverse effect is disruption of thyroid function (hypo- or hyperthyroidism) due to amiodarone's structural similarity to thyroid hormones. Neurological and gastrointestinal toxicities are concentration-dependent, whereas thyroid dysfunction, pulmonary fibrosis, and hepatotoxicity are more loosely linked to drug concentration. There is significant potential for drug interactions involving amiodarone, including several other cardioactive drugs (eg, digoxin, verapamil, class I antiarrhythmics [sodium channel blockers]), warfarin, statins, and CYP3A4 substrates.

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.

AMIODARONE

Trough Value

0.5-2.0 mcg/mL: Therapeutic concentration

>2.5 mcg/mL: Toxic concentration

 

DESETHYLAMIODARONE:

No therapeutic range established for desethylamiodarone; activity and serum concentration are similar to parent drug.

Interpretation
Provides information to assist in interpretation of the test results

Clinical effects generally require serum concentrations above 0.5 mcg/mL.

 

Increased risk of toxicity is associated with amiodarone concentrations above 2.5 mcg/mL.

 

Although therapeutic and toxic ranges are based only on the parent drug, the active metabolite N-desethylamiodarone should be present in similar concentrations to amiodarone.

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

Numerous drug interactions have been observed for amiodarone. Clinical follow-up is essential for optimal use of amiodarone. Therapeutic drug monitoring for amiodarone and coadministered medications is highly recommended.

 

Specimens that are obtained from gel tubes or anticoagulate collections can cause assay interference.

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

1. Goldschlager N, Epstein AE, Naccarelli GV, et al: A practical guide for clinicians who treat patients with amiodarone: 2007. Heart Rhythm. 2007 Sep;4(9):1250-1259

2. Klotz U: Antiarrhythmics: elimination and dosage considerations in hepatic impairment. Clin Pharmacokinet. 2007;46(12):985-996

3. Campbell TJ, Williams KM: Therapeutic drug monitoring: antiarrhythmic drugs. Br J Clin Pharmacol. 2001;52 Suppl1(Suppl 1):21S-34S

4. Rifai N, Horwath AR, Wittwer CT, eds: In: Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018

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

Protein is precipitated from serum and following centrifugation the supernatant is diluted and analyzed by liquid chromatography tandem 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.

Monday through Saturday

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.

3 to 5 days

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

2 weeks

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.

80151

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
AMIO Amiodarone, S 55152-3
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.
9247 Amiodarone, S 3330-8
2485 Desethylamiodarone 6774-4

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