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HelpTest Code FENS Fentanyl Screen, Random, Urine
Useful For
Screening for drug abuse or use involving fentanyl
Reporting Name
Fentanyl Screen, USpecimen Type
UrineOrdering 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 following test should also be ordered, ADULT / Adulterants Survey, Random, Urine.
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: 2 mL
Collection Instructions:
1. Collect a random urine specimen.
2. No preservative.
Specimen Minimum Volume
0.5 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.
Reference Values
Negative
Screening cutoff concentration: 2 ng/mL
Interpretation
This assay only provides a preliminary analytical test result. A more specific alternative method (ie, liquid chromatography tandem mass spectrometry) must be used to obtain a confirmed analytical result.
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 false-positive or false-negative results.
Method Description
This assay is a homogeneous enzyme immunoassay technique and is performed semi-quantitatively. 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 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 |
|---|---|---|
| FENS | Fentanyl Screen, U | 59673-4 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 63060 | Fentanyl Screen, U | 59673-4 |
Method Name
Immunoassay