What is Fentanyl?

Fentanyl is a synthetic narcotic analgesic of high potency and short duration of action. The drug is available as a citrate salt in an injectable solution containing 50 μg/mL. It is also available as a transdermal patch containing 2.5–10 mg fentanyl and provides a dose of 25–100 μg/hr for 72 hours for management of chronic pain.


The fentanyl epidemic has been exponentially increasing in the United States, according to CDC data.


The first step to saving lives by preventing fentanyl deaths is more comprehensive testing.


Why Use a Designated Fentanyl Assay?

While fentanyl has all the properties of morphine, it is structurally different and therefore cannot be detected by screening tests for morphine and related opiates.

The Fentanyl Urine Drug Screening Kit is the first-ever FDA 510(k) cleared fentanyl immunoassay.


What is the Fentanyl Urine Drug Screening Kit?

The Fentanyl Urine Drug Screening Kit detects the presence of fentanyl and its major metabolites in human urine samples with a cutoff of 1 ng/mL for qualitative testing.

In clinical performance studies, testing with the Fentanyl Urine Drug Screening Kit compared favorably to liquid chromatography-mass spectrometry (LC-MS) analysis in both sensitivity (identification of positive results) and specificity (identification of negative results).

  • FDA 510(k) Cleared
  • Designed for qualitative testing at 1 ng/mL cutoff
  • CLIA Moderate Complexity
  • Demonstrated crossreactivity with acetyl fentanyl and butyryl fentanyl
  • Accurate and trusted results
  • Liquid stable and ready to use
  • Compatible with all AU series analyzers

The Fentanyl Urine Enzyme Immunoassay contains two reagents, which are provided as ready-to-use:

  1. Antibody/Enzyme Donor (EA) – This reagent contains rabbit antibodies to fentanyl, and a partial sequence to galactosidase in PIPES buffer with Sodium Azide as a preservative.
  2. Substrate/Enzyme Acceptor (ED) – This reagent contains the complementary sequence of β-galactosidase labeled with fentanyl in malic acid buffer with Sodium Azide as a preservative.

The Fentanyl Urine Calibrators are sold as individual bottles and are liquid and ready to use. The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. Each calibrator (1, 2, and 4 ng/mL) contains a known concentration of Fentanyl spiked into the negative calibrator matrix.

Fentanyl reagent

The Fentanyl Urine Drug Screening Kit is compatible with all AU Series Analyzers and the Immunalysis ImmTox™ 270 Benchtop Analyzer.

Click here for more Immunalysis Toxicology Reagents.

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