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HelpMayo Test ID FENR Fentanyl Screen with Reflex, Random, 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
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.
Useful For
Screening for drug abuse or use involving fentanyl and confirmation of fentanyl if present in the screen
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| FENS | Fentanyl Screen, U | Yes | Yes |
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| FENTU | Fentanyl w/metabolite Conf, U | Yes | No |
Testing Algorithm
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
Immunoassay
Reporting Name
Fentanyl Screen w/Reflex, USpecimen Type
UrineSpecimen Minimum Volume
2.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Urine | Refrigerated (preferred) | 14 days | |
| Frozen | 14 days | ||
| Ambient | 72 hours |
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Clinical Information
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
Negative
Screening cutoff concentration: 2 ng/mL
Interpretation
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
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
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
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)
Day(s) Performed
Monday through Saturday
Report Available
Same day/1 to 2 daysSpecimen Retention Time
14 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
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.CPT Code Information
80307
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| FENR | Fentanyl Screen w/Reflex, U | 59673-4 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 63060 | Fentanyl Screen, U | 59673-4 |