OVERVIEW

Purpose: Detection and quantification of fentanyl in urine. Preferred test to follow-up presumptive results for fentanyl screening test.

CLINICAL INFORMATION

This test detects the presence and quantifies the amount of fentanyl and its primary metabolite norfentanyl in patient urine sample.

Fentanyl, an exceedingly fast-acting synthetic opioid belonging to the phenylpiperidine class, is accessible in both injectable and transdermal formulations. The analgesic properties of fentanyl resemble those of morphine and other opioids. In clinical setting, fentanyl exerts its primary pharmacological influences on the central nervous system (CNS). Alongside its analgesic effects, it frequently triggers alterations in mood (ranging from euphoria to dysphoria) and drowsiness. The similarity between fentanyl's biological effects and those of heroin and other opioids has contributed to its widespread misuse as a recreational substance.

In humans, the drug's metabolic pathway primarily involves oxidative N-dealkylation, resulting in the formation of norfentanyl and other inert metabolites that minimally impact the drug's observed effects. Following intravenous (IV) administration, approximately 75% of the dosage is excreted via urine within 72 hours, with the majority being metabolites, and less than 10% remains unchanged.

SPECIMEN COLLECTION

Specimen Type: Random Urine
Preferred Collection Container: Non-sterile specimen container
Specimen Required: 3 mL urine; minimum 1 mL

TEST DETAILS

Methodology: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
Compliance Category: Laboratory Developed Test (LDT)
Intended for medical use only; not suitable for forensic applications. This test was developed and assessed by DMD in compliance with CLIA requirements for its analytical performance characteristics and clinical application. This test has not been cleared or approved by the U.S. Food and Drug Administration. The absence of anticipated drug(s) and/or their metabolites may suggest noncompliance, improper timing of specimen collection, inadequate drug absorption, diluted/adulterated urine or inherent testing limitations. A concentration equal to or exceeding the defined cutoff is considered positive. Requiring interpretation should be referred to the laboratory. Quantitative values obtained from this test cannot be directly employed to assess drug dosage because the drug is extensively metabolized and excreted in the urine.
Reference Interval: Negative
Drug/Metabolite Tested:
Drug/Metabolite Cutoff concentration 500 ng/mL
Fentanyl 1 ng/mL
Norfentanyl 2 ng/mL
CPT code(s): 80354
Turnaround Time: 90% < 48 hours, 50% < 24 hours

SPECIMEN PROCESSING

Transport Temperature: Refrigerated (preferred) or room temperature overnight shipping.
Specimen Stability: 3 days at room temperature and 14 days at refrigerated and frozen temperatures (to be further confirmed with our validation).
Rejection Criteria: Stability limits exceeded.

Director: Cheryl Hanau, MD; Garth Ehrlich, PhD, FAAAS, FAAM; Donald Hall Jr., PhD; Yinghua Qiu, PhD, DABCC

Review Date: 08/28/2023

Note: The billing party has sole responsibility for CPT coding. Any questions regarding coding should be directed to the payer being billed. The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.

The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.

 
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