Test Catalog

Test Id : FENTS

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Fentanyl, Serum

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Overview

Test Catalog

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

Monitoring fentanyl therapy

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

Liquid Chromatography Tandem 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

Fentanyl and Metabolites, S

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

Fentanyl (Sublimaze)

Innovar

Sublimaze (Fentanyl)

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

Supplies: Sarstedt Aliquot Tube 5 mL (T914)

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

Submission Container/Tube: Plastic vial

Specimen Volume: 2.3 mL

Collection Instructions: Within 2 hours of collection, centrifuge and aliquot serum into a plastic vial.

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

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.

1.25 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 Frozen (preferred) 28 days
Refrigerated 14 days
Ambient 72 hours

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

Monitoring fentanyl therapy

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

Fentanyl is an extremely fast-acting synthetic opioid related to the phenylpiperidines.(1,2) It is available in injectable as well as transdermal formulations.(1) The analgesic effects of fentanyl are similar to those of morphine and other opioids(1), as it interacts predominantly with the opioid mu-receptor. These mu-binding sites are discretely distributed in the human brain, spinal cord, and other tissues.(1,3)

 

Fentanyl is approximately 80% to 85% protein bound.(1) Fentanyl plasma protein-binding capacity decreases with increasing ionization of the drug. Alterations in pH may affect its distribution between plasma and the central nervous system (CNS). The average volume of distribution for fentanyl is 6 L/kg (range 3-8).(3,4)

 

In humans, the drug appears to be metabolized primarily by oxidative N-dealkylation to norfentanyl and other inactive metabolites that do not contribute materially to the observed activity of the drug. Within 72 hours of intravenous (IV) administration, approximately 75% of the dose is excreted in urine, mostly as metabolites with less than 10% representing unchanged drug.(3,4)

 

The mean elimination half-life is:(1-3)

-IV: 2 to 4 hours

-Iontophoretic transdermal system (Ionsys), terminal half-life: 16 hours

-Transdermal patch: 17 hours (range 13-22 hours, half-life is influenced by absorption rate)

-Transmucosal:

 -Lozenge: 7 hours

 -Buccal tablet

  -100 to 200 mcg: 3 to 4 hours

  -400 to 800 mcg: 11 to 12 hours

 

In clinical settings, fentanyl exerts its principal pharmacologic effects on the CNS. In addition to analgesia, alterations in mood (euphoria, dysphoria) and drowsiness commonly occur.(1,3) Because the biological effects of fentanyl are similar to those of heroin and other opioids, fentanyl has become a popular drug of abuse.

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.

Not applicable

Interpretation
Provides information to assist in interpretation of the test results

Both fentanyl and norfentanyl are reported.

 

Tolerant individuals may require many-fold increases in dose to achieve the same level of analgesia, which can greatly complicate interpretation of therapeutic drug monitoring results and establishment of a therapeutic window.

 

Concentration at which toxicity occurs varies and should be interpreted in light of clinical situation.

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

Specimens collected in serum gel tubes are not acceptable because the drug can absorb on the gel and lead to falsely decreased concentrations.

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

1. Gutstein HB, Akil H. Opioid analgesics. In: Brunton LL, Lazo JS, Parker KL, eds. Goodman and Gilman's: The Pharmacological Basis of Therapeutics. 11th ed. McGraw-Hill Companies; 2006:chap 21

2. Kerrigan S, Goldberger BA. Opioids. In: Levine B, eds. Principles of Forensic Toxicology. 2nd ed. AACC Press; 2003:187-205

3. DURAGESIC (fentanyl transdermal system). Package insert: Janssen Pharmaceutica Products, LP; 2006

4. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 12th ed. Biomedical Publications; 2020

5. Yaksh T, Wallace M. Opioids, Analgesia, and Pain Management. In: Brunton LL, Hilal-Dandan R, Knollmann BC, eds. Goodman and Gilman's: The Pharmacological Basis of Therapeutics, 13th ed. McGraw-Hill Education; 2017

6. Langman LJ, Bechtel LK, Holstege CP. Clinical toxicology. In: Rifai N, Chiu RWK, Young I, Burnham CAD, Wittwer CT, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:chap 43

7. Fentanyl. In: Merative Micromedex (electronic version). Merative US 2024. Accessed July 15, 2024. Available at www.micromedexsolutions.com

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

Fentanyl is isolated from serum using a liquid/liquid extraction. The solvent is dried, and the analytes are reconstituted with mobile phase. Analysis is performed by liquid chromatography tandem mass spectrometry using selected ion monitoring.(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.

  • 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.

80354

G0480 (if appropriate)

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
FENTS Fentanyl and Metabolites, S 81275-0
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.
31829 Norfentanyl 11074-2
31830 Fentanyl 3636-8
31832 Chain of Custody 77202-0

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
Test Status - Test Resumed 2024-09-30
Test Status - Test Down 2023-01-16
Test Status - Test Resumed 2022-12-21
Test Status - Test Down 2022-12-14