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HelpTest Code SOFT: Z1000 Fentanyl with Metabolite Confirmation, Random, Urine
Additional Codes
| Ordering Mnemonic | Mayo Test ID |
|---|---|
| HOM: MISC LAB | FENTU |
Reporting Name
Fentanyl w/metabolite Conf, UUseful For
Detection and confirmation of illicit drug use involving fentanyl
Method Name
Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
UrineOrdering Guidance
For situations where chain of custody is required, a Chain of Custody Kit (T282) is available. For chain-of-custody testing, order FENTX / Fentanyl with Metabolite Confirmation, Chain of Custody, Random, Urine.
Additional Testing Requirements
If urine creatinine is required or adulteration of the sample is suspected, the following test should also be ordered, ADULT / Adulterants Survey, Random, Urine.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Clean, plastic urine collection container
Submission Container/Tube: Plastic, 5-mL tube
Specimen Volume: 5 mL
Collection Instructions:
1. Collect a random urine specimen.
2. No preservative.
Additional Information:
1. No specimen substitutions.
2. STAT requests are not accepted for this procedure.
3. Submitting less than 5 mL will compromise our ability to perform all necessary testing.
Specimen Minimum Volume
2.1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Urine | Refrigerated (preferred) | 28 days | |
| Frozen | 28 days | ||
| Ambient | 21 days |
Reject Due To
| Gross hemolysis | OK |
| Gross icterus | Reject |
Reference Values
Negative
Day(s) Performed
Monday through Friday
CPT Code Information
80354
G0480 (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| FENTU | Fentanyl w/metabolite Conf, U | 67822-7 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 45530 | Fentanyl by LC-MS/MS | 58381-5 |
| 45531 | Norfentanyl by LC-MS/MS | 58383-1 |
| 45532 | Fentanyl Interpretation | 69050-3 |
Test Classification
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.Clinical Information
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 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 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 (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.
Interpretation
The presence of fentanyl above 0.20 ng/mL or norfentanyl above 1.0 ng/mL is a strong indicator that the patient has used fentanyl.
Cautions
Urine concentrations do not correlate well to serum drug levels. For therapeutic drug management, monitor serum levels.
Very high concentrations of butyl fentanyl (> 5 mcg/mL) and acetyl fentanyl (> 10 mcg/mL) can potentially interfere and cause a low positive (<0.5 ng/mL) fentanyl concentration, but no interference is noted with norfentanyl.
Clinical Reference
1. Gutstein HB, Akil H. Opioid analgesics. In: Hardman JG LL, Gilman AG, eds. Goodman and Gilman's: The Pharmacological Basis of Therapeutics. 11th ed. McGraw-Hill; 2006:chap 21
2. Kerrigan S, Goldberger BA. Opioids. In: Levine ZB, ed. Principles of Forensic Toxicology. 2nd ed. AACC Press; 2003:187-205
3. DURAGESIC (fentanyl transdermal system). Package insert. Janssen Pharmaceutical Products. LP; 2006
4. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 8th ed. Biomedical Publications; 2008:616-619
5. Langman LJ, Bechtel LK, Meier BM, Holstege C. Clinical toxicology. In: Rifai N, Horvath AR, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 7th ed. Elsevier; 2023
Method Description
The received urine sample is centrifuged, diluted, mixed with internal standard and ammonium hydroxide, and vortexed briefly. It is then extracted using supported liquid extraction, and the extract analyzed by an in-house developed liquid chromatography tandem mass spectrometry method.(Unpublished Mayo method)
Report Available
4 to 7 daysSpecimen Retention Time
14 daysForms
If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.