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Test ID FENTX Fentanyl with Metabolite Confirmation, Chain of Custody, Urine

Useful For

Detection and confirmation of illicit drug use involving fentanyl

 

Chain of custody is required whenever the results of testing could be used in a court of law. Its purpose is to protect the rights of the individual contributing the specimen by demonstrating that it was under the control of personnel involved with testing the specimen at all times; this control implies that the opportunity for specimen tampering would be limited.

Additional Tests

Test ID Reporting Name Available Separately Always Performed
COCH Chain of Custody Processing No Yes
ADLTX Adulterants Survey, CoC, U Yes Yes

Testing Algorithm

Adulterants testing will be performed on all chain of custody urine samples as per regulatory requirements.

Method Name

Immunoassay/Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

Reporting Name

Fentanyl w/metabolite Conf, CoC, U

Specimen Type

Urine

Container/Tube: Chain-of-Custody Kit (T282) containing the specimen containers, seals, and documentation required.

Specimen Volume: 20 mL

Collection Instructions: Collect specimen in the container provided, seal, and submit with the associated documentation to satisfy the legal requirements for chain-of-custody testing.

Additional Information: Submitting <20 mL will compromise our ability to perform all necessary testing.

Forms: Chain-of-Custody Request Form is included in the Chain-of-Custody Kit (T282). A copy of this form is also available at http://www.mayomedicallaboratories.com/it-mmfiles/chain-of-custody-request-form.pdf.

Specimen Minimum Volume

2.1 mL

Specimen Stability Information

Specimen Type Temperature Time
Urine Refrigerated (preferred) 14 days
  Frozen  14 days
  Ambient  72 hours

Clinical Information

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.

 

Chain of custody is a record of the disposition of a specimen to document who collected it, who handled it, and who performed the analysis. When a specimen is submitted in this manner, analysis will be performed in such a way that it will withstand regular court scrutiny.

Reference Values

Negative

 

Cutoff concentrations:

Immunoassay screen

<2 ng/mL

 

Fentanyl by LC-MS/MS

0.2 ng/mL

 

Norfentanyl by LC-MS/MS

1.0 ng/mL

Cautions

Urine concentrations do not correlate well to serum drug levels. For therapeutic drug management, monitor serum levels using FENTS / Fentanyl, Serum.

Day(s) Performed

Monday through Thursday

Report Available

3 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

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

80354

G0480 (if appropriate)

NY State Approved

No