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Test Code FENR Fentanyl Screen with Reflex, Random, Urine

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.

Reporting Name

Fentanyl Screen w/Reflex, U

Specimen Type

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.


Specimen 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.

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

Performing 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

Method Name

Immunoassay

Forms

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

Secondary ID

63061