Test Catalog

Test Id : FENTX

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Fentanyl with Metabolite Confirmation, Chain of Custody, Random, Urine

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Lists tests that are always performed, at an additional charge, with the initial 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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Method Name
A short description of the method used to perform the test

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

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Fentanyl w/metabolite Conf, CoC, U

Aliases
Lists additional common names for a test, as an aid in searching

Fentanyl (Sublimaze)

Innovar

Sublimaze (Fentanyl)

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Specimen Type
Describes the specimen type validated for testing

Urine

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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

Specimen Volume: 5 mL

Collection Instructions: Collect random urine 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 less than 5 mL will compromise the ability to perform all necessary testing.

Forms

1. Chain of Custody Request is included in the Chain-of-Custody Kit (T282).

2. If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

2.1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross icterus Reject
  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Urine Refrigerated (preferred) 28 days
Frozen 28 days
Ambient 21 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

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.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

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 are 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 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 each individual who collected, handled, and 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
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

 

Cutoff concentrations:

Immunoassay screen

<2 ng/mL

 

Fentanyl by liquid chromatography-tandem mass spectrometry (LC-MS/MS)

0.2 ng/mL

 

Norfentanyl by LC-MS/MS

1.0 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

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
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.

 

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
Recommendations for in-depth reading of a clinical nature

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
Describes how the test is performed and provides a method-specific reference

This screen is a homogeneous enzyme immunoassay technique. The immunoassay will be performed semiquantitatively. The immunoassay method is based on competition between free drug in the urine sample, and a drug labeled with the enzyme glucose-6-phosphate dehydrogenase for a fixed amount of specific antibody binding sites. Active enzyme converts nicotinamide adenine dinucleotide (NAD+) to NADH, which results in an absorbance change that can be measured spectrophotometrically at 340nm.(Package insert: Fentanyl Enzyme Immunoassay. Immunalysis Corporation; 10/2016)

 

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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

4 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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.

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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80354

G0480 (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
FENTX Fentanyl w/metabolite Conf, CoC, U 67822-7
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
36190 Norfentanyl by LC-MS/MS 58383-1
36191 Fentanyl by LC-MS/MS 58381-5
36192 Fentanyl Interpretation 69050-3
36193 Chain of Custody 77202-0
36653 Fentanyl Immunoassay Screen 59673-4

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
Test Status - Test Resumed 2023-06-29
Test Status - Test Delay 2023-06-26