Test ID: FENTU
Fentanyl Confirmation, Urine
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Detection and confirmation of illicit drug use involving fentanyl
Additional Tests Lists test(s) that are always performed, at an additional charge, with the initial test(s)
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| ADULT | Adulterants Survey, U | No | Yes |
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
An evaluation to detect the presence of adulterants will be performed and reported at no additional charge.
See Adulterant Survey Algorithm in Special Instructions.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
FENTU/89655: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
ADULT/29345: Spectrophotometry (SP)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Innovar
Sublimaze (Fentanyl)
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: Clean, plastic urine collection container
Submission Container/Tube: Plastic, 10-mL urine tube (Supply T068)
Specimen Volume: 3 mL
Collection Instructions:
1. Collect a random urine specimen.
2. No preservative.
Additional Information:
1. No specimen substitutions.
2. No STATS are accepted for this procedure.
3. For situations where chain-of-custody is required, a Chain-of-Custody Kit (Supply T282) is available. For chain-of-custody information, see COCH/9426 Chain-of-Custody Processing.
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.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | NA |
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 Type | Temperature | Time |
|---|---|---|
| Urine | Refrigerated (preferred) | 7 days |
| Frozen | 14 days | |
| Ambient | 72 hours |
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 phenylpiperidiens.(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 tissue.(1,3)
Fentanyl is approximately 80% to 85% protein bound. In plasma, the protein binding capacity of fentanyl 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 <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 (13-22 hours, half-life is influenced by absorption rate)
-Transmucosal:
- 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 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.
Negative
Interpretation Provides information to assist in interpretation of the test results
The presence of fentanyl >0.20 ng/mL or norfentanyl >1.0 ng/mL is a strong indicator that the patient has used fentanyl.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Urine concentrations do not correlate well to serum drug levels. For therapeutic drug management, monitor serum levels using FENTS/89654 Fentanyl, Serum.
For situations where chain-of-custody is required, a Chain-of-Custody Kit is available, see COCH/9426 Chain-of-Custody Processing.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Gutstein HB, Akil H: Opioid analgesics. In Goodman & Gilman's: The Pharmacological Basis of Therapeutics. Vol. 11. Edited by JG LL Hardman, AG Gilman. New York, McGraw-Hill Book Company Inc. 2006, Chapter 21
2. Kerrigan S, Goldberger BA: Opioids. In Principles of Forensic Toxicology. 2nd Edition. Edited by ZB Levine. Washington DC, AACC Press, 2003, pp 187-205
3. Package insert: DURAGESIC (fentanyl transdermal system). Janssen Pharmaceutica Products. Titusville, NJ. LP, 2006
4. Baselt RC: Disposition of Toxic Drugs and Chemicals in Man. 8th edition. Foster City, CA. Biomedical Publications, 2008, pp 616-619
Method Description Describes how the test is performed and provides a method-specific reference
Fentanyl is isolated from urine 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 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.
Monday through Thursday
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.
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.
80299
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 |
|---|---|---|
| 45531 | Norfentanyl | 11075-9 |
| 45530 | Fentanyl | 3637-6 |
| 45532 | Interpretation | 69050-3 |
| 45533 | Chain of Custody | In Process |
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