NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Monitoring fentanyl therapy
Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Fentanyl and Metabolites, S
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.
Container/Tube: Red top
Specimen Volume: 2.3 mL
Collection Instructions: Spin down 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.
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
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 is similar to those of morphine and other opioids (1); 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. 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 <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 103-22 hours, half-life is influenced by absorption rate)
- Lozenge: 7 hours
- Buccal tablet
- 100 mcg to 200 mcg: 3 to 4 hours
- 400 mcg to 800 mcg: 11 to 12 hours
In clinical settings, fentanyl exerts its principal pharmacologic effects on the central nervous system. In additions 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.
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 (TDMA) results and establishment of a therapeutic window.
Concentration at which toxicity occurs varies and should be interpreted in light of clinical situation.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Gutstein HB, Akil H: Opioid analgesics. In Goodman & Gilmans The Pharmacological Basis of Therapeutics. Vol. 11. Edted by JG LL Hardman, AG Gilman AG, New York, McGraw-Hill Book Company, Inc, 2006, Chpater 21
2. Kerrigan S, Goldberger BA: Opioids. In Principles of Forensic Toxicology, Edited by B Levine. 2nd edition. Washington DC AACC Press, 2003, pp 187-205
3. Package insert: DURAGESIC (fentanyl transdermal system. Pharmaceutica Products, L.P., 2006
4. Baselt RC: Disposition of Toxic Drugs and Chemicals in Man. 8th edition. Foster City, CA. Biochemical Publications. 2008 pp 616-619
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 mass spectrometry/mass spectrometry using selected ion monitoring. (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.
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|
|31832||Chain of Custody||In Process|