Test Catalog

Test Id : FENR

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Fentanyl Screen with Reflex, Random, Urine

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Overview

Test Catalog

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

Screening for drug abuse or use involving fentanyl and confirmation of fentanyl if present in the screen

Profile Information
A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test Id Reporting Name Available Separately Always Performed
FENS Fentanyl Screen, U Yes Yes

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
FENTU Fentanyl w/metabolite Conf, U Yes No

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

Testing begins with a screening assay. If the fentanyl screen is positive, then the liquid chromatography tandem mass spectrometry confirmation with quantification will be performed at an additional charge.

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

Immunoassay

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 Screen w/Reflex, 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.

Testing begins with a screening assay. If the fentanyl screen is positive, then the liquid chromatography tandem mass spectrometry confirmation with quantification will be performed at an additional charge.

Specimen Type
Describes the specimen type validated for testing

Urine

Ordering 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, Urine.

 

For monitoring therapeutic drug levels, order FENTS / Fentanyl, Serum.

Additional Testing Requirements

If urine creatinine is required or adulteration of the sample is suspected, the ADULT / Adulterants Survey, Random, Urine test should also be ordered.

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

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.

Forms

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

2.5 mL

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

  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) 14 days
Frozen 14 days
Ambient 72 hours

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

Screening for drug abuse or use involving fentanyl and confirmation of fentanyl if present in the screen

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

Testing begins with a screening assay. If the fentanyl screen is positive, then the liquid chromatography tandem mass spectrometry confirmation with quantification will be performed at an additional charge.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

This procedure uses immunoassay reagents that are designed to produce a negative result when no drugs are present in a natural (ie, unadulterated) specimen of urine; the assay is designed to have a high true-negative rate. Like all immunoassays, it can have a false-positive rate due to cross-reactivity with natural chemicals and drugs other than those they were designed to detect. The immunoassay also has a false-negative rate due to the antibody's ability to cross-react with different drugs in the class being screened for.

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

Screening cutoff concentration: 2 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

If the screen result is negative, fentanyl concentrations above 0.20 ng/mL were not detected.

 

If the screen result is positive, then confirmation by liquid chromatography tandem mass spectrometry will be performed.

 

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

Care should be taken when interpreting results since there are many factors (eg, fluid intake and other biologic factors) that may influence a urine test result. It is possible that substances other than those investigated in the specificity study may interfere with the test and cause either false-positive or false-negative results.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Gutstein HB, Akil H. Opioid analgesics. In: Brunton LL, Lazo JS, Parker KL, eds: Goodman and Gilman's: The Pharmacological Basis of Therapeutics. 11th ed. McGraw-Hill Companies; 2006:chap 21

2. Kerrigan S, Goldberger BA. Opioids. In: Levine ZB, eds. 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, Holstege CP. Clinical toxicology. In: Rifai N, Chiu RWK, Young I, Burnham CAD, Wittwer CT, eds Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:chap 43

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

This assay is a homogeneous enzyme immunoassay technique. The assay will be performed semiquantitatively. The assay 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 340 nm.(Package insert: Fentanyl Enzyme Immunoassay. Immunalysis Corporation; 10/2016)

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 Saturday

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.

Same day/1 to 2 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.

80307

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
FENR Fentanyl Screen w/Reflex, U 59673-4
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.
63060 Fentanyl Screen, U 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 | PHP Pdf | CMS 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