Screening for drug abuse or use involving fentanyl
Immunoassay
Fentanyl (Sublimaze)
Innovar
Sublimaze (Fentanyl)
Urine
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.
If urine creatinine is required or adulteration of the sample is suspected, the following test should also be ordered, ADULT / Adulterants Survey, Random, Urine.
Supplies: Urine Tubes, 10 mL (T068)
Collection Container Tube: Plastic urine container
Submission Container/Tube: 10 mL tube
Specimen Volume: 2 mL
Collection Instructions:
1. Collect a random urine specimen.
2. No preservative.
If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.
0.5 mL
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Urine | Refrigerated (preferred) | 14 days | |
Frozen | 14 days | ||
Ambient | 72 hours |
Screening for drug abuse or use involving fentanyl
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.
Negative
Screening cutoff concentration: 2 ng/mL
This assay only provides a preliminary analytical test result. A more specific alternative method (ie, liquid chromatography-tandem mass spectrometry: LC-MS/MS) must be used to obtain a confirmed analytical result.
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 negative results.
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; 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. Baselt RC: Disposition of Toxic Drugs and Chemicals in Man. 8th ed. Biomedical Publications; 2008:616-619
4. 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. 6th ed. Elsevier; 2018:832-887
This assay is a homogeneous enzyme immunoassay technique. The assay will be 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)
Monday through Saturday
This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.
80307
Test Id | Test Order Name | Order LOINC Value |
---|---|---|
FENS | Fentanyl Screen, 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 |
Change Type | Effective Date |
---|---|
Test Changes - Specimen Information | 2021-10-25 |