NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Monitoring amiodarone therapy, especially when amiodarone is coadministered with other drugs that may interact
Evaluation of possible amiodarone toxicity
Assessment of patient compliance
High-Turbulence Liquid Chromatography Mass Spectrometry (HTLC-MS/MS)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Pacerone (Amiodarone Hydrochloride)
Pacerone (Amiodarone Hydrochloride)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Collection Container/Tube: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 3 mL
Collection Instructions: Draw blood no sooner than 12 hours (trough value) after last dose.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross reject
Mild OK; Gross reject
Serum gel tube
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum Red||Frozen (preferred)||14 days|
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 U.S. 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 95% protein bound in blood, with a volume of distribution of 60 L/kg. Amiodarone elimination is quite prolonged, with a mean half-life of 53 days. CYP3A4 converts amiodarone to its equally active metabolite, N-desethylamiodarone (DEA), which displays very similar pharmacokinetics and serum concentrations, compared to 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.
Therapeutic concentration: 0.5-2.0 mcg/mL
Toxic concentration: >2.5 mcg/mL
No therapeutic range established; activity and serum concentration are similar to parent drug.
Clinical effects generally require serum concentrations >0.5 mcg/mL. Increased risk of toxicity is associated with amiodarone concentrations >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.
Clinical Reference Provides recommendations for further 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. Heart Rhythm 2007;4:1250-1259
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 Suppl1:21S-34S
Method Description Describes how the test is performed and provides a method-specific reference
Amiodarone and DEA are diluted in serum with acidic aqueous diluent, containing a deuterated internal standard. Samples are then extracted online by use of turbulent flow technology, and analyzed by liquid chromatography-tandem mass spectrometry (HTLC-MS/MS). (Unpublished Mayo method)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 8 a.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|