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Test ID: AMT
Amitriptyline and Nortriptyline, Serum

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

Yes

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

Monitoring serum concentration during therapy

 

Evaluating potential toxicity

 

The test may also be useful to evaluate patient compliance

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

High-Performance Liquid Chromatography (HPLC)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Amitriptyline and Nortriptyline, S

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

Amitriptyline (Elavil)
Elavil (Amitriptyline)
Elavil, Tryptanol, Endep, Elatrol, Tryptizol, Trepiline, Laroxyl, Saroten, Triptyl, Redomex (Amitriptyline)
Nortriptyline (Pamelor)
Pamelor (Nortriptyline)
Sensoval, Aventyl, Pamelor, Norpress, Allegron, and Nortrilen (Nortriptyline)
TCA (Tricyclic Antidepressants)
Tricyclic Antidepressants (TCA)

Specimen Type Describes the specimen type needed for testing

Serum Red

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.

Container/Tube: Red top

Specimen Volume: 3 mL

Collection Instructions:

1. Draw specimen immediately before next scheduled dose (minimum 12 hours after last dose).

2. Serum must be separated from cells within 2 hours of draw.

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.

1.1 mL

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

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross reject

Other

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.

Specimen TypeTemperatureTime
Serum RedRefrigerated (preferred)14 days
 Ambient 14 days
 Frozen 14 days

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

Amitriptyline is a tricyclic antidepressant that is metabolized to nortriptyline, which has similar pharmacologic activity. The relative blood levels of amitriptyline and nortriptyline are highly variable among patients. Amitriptyline is the drug of choice in treatment of depression when the side effect of mild sedation is desirable. Nortriptyline is used when its stimulatory side effect is considered to be of clinical advantage.

 

Amitriptyline displays major cardiac toxicity when the concentration of amitriptyline and nortriptyline is in excess of 300 ng/mL, characterized by QRS widening leading to ventricular tachycardia and asystole. In some patients, toxicity may manifest at lower concentrations.

 

Nortriptyline is unique among the antidepressants in that its blood level exhibits the classical therapeutic window effect; blood concentrations above or below the therapeutic window correlate with poor clinical response. Thus, therapeutic monitoring to ensure that the blood level is within the therapeutic window is critical to accomplish successful treatment with this drug.

 

Like amitriptyline, nortriptyline can cause major cardiac toxicity when the concentration is in excess of 300 ng/mL, characterized by QRS widening leading to ventricular tachycardia and asystole. In some patients, toxicity may manifest at lower concentrations.

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.

AMITRIPTYLINE AND NORTRIPTYLINE

Total therapeutic concentration: 80-200 ng/mL

Total toxic concentration: > or =300 ng/mL

 

NORTRIPTYLINE ONLY

Therapeutic concentration: 70-170 ng/mL

Toxic concentration: > or =300 ng/mL

Note: Therapeutic ranges are for specimens drawn at trough (ie, immediately before next scheduled dose). Levels may be elevated in non-trough specimens.

Interpretation Provides information to assist in interpretation of the test results

Most individuals display optimal response to amitriptyline when combined serum levels of amitriptyline and nortriptyline are between 80 and 200 ng/mL. Risk of toxicity is increased with combined levels > or =300 ng/mL.

 

Most individuals display optimal response to nortriptyline with serum levels between 70 and 170 ng/mL. Risk of toxicity is increased with nortriptyline levels > or =300 ng/mL.

 

Some individuals may respond well outside of these ranges, or may display toxicity within the therapeutic range, thus interpretation should include clinical evaluation.

 

Therapeutic ranges are based on specimens drawn at trough (ie, immediately before the next dose).

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

Amitriptyline analytical interferences; sertraline may cause falsely low results, and clomipramine, amlodipine, chlorpheniramine, chlorpromazine, promazine, trihexyphenidyl, citalopram, or escitalopram may cause false elevations.

 

Nortriptyline analytical interferences; sertraline may cause falsely low results, and metformin may cause false elevations.

 

This test cannot be performed on whole blood. Serum must be separated from cells within 2 hours of drawing; if serum is not removed within this time, tricyclic antidepressant levels may be falsely elevated due to drug release from RBCs. Specimens that are obtained from gel tubes are not acceptable.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Wille SM, Cooreman SG, Neels HM, Lambert WE: Relevant issues in the monitoring and the toxicology of antidepressants. Crit Rev Clin Lab Sci 2008;45(1):25-89

2. Thanacoody HK, Thomas SH: Antidepressant poisoning. Clin Med 2003;3(2):114-118

3. Baumann P, Hiemke C, Ulrich S, et al: The AGNP-TDM expert group consensus guidelines: therapeutic drug monitoring in psychiatry. Pharmacopsychiatry 2004;37(6):243-265

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

The tricyclic antidepressants are extracted from serum by liquid-liquid extraction. Analysis is by HPLC. (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; Varies

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.

2 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

4 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 The location of the laboratory that performs the test

Rochester

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.

80152-Amitriptyline

80182-Nortriptyline

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 IDReporting NameLOINC Code
8125Amitriptyline3333-2
2450Nortriptyline3872-9
2451Amitriptyline and Nortriptyline3335-7