Fentanyl Screen Panel, Urine

The Immunalysis SEFRIA ™ Fentanyl Urine Enzyme Immunoassay is an in vitro diagnostics test for the qualitative analysis of Fentanyl in human urine with automated clinical chemistry analyzers. This test is an enzyme immunoassay with a cut-off of 1.0 ng/mL.

The Immunalysis SEFRIA ™ Fentanyl Urine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography/ Mass Spectrometry (LS-MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The SEFRIA™ technology is based on artificial fragments of the E.coli enzyme β-galactosidase. A mutant enzyme, termed Enzyme Acceptor (EA), is created by deletion of a short sequence in the amino-terminal region of the sequence. EA is inactive, but can combine with peptides, termed Enzyme Donors (ED), containing the deleted sequence, to form active β-galactosidase. This process is termed complementation, and the active enzyme formed as a result can be measured by hydrolysis of a chromogenic substrate such as chlorophenored β-D-galactopyranoside (CPRG). The ED peptides can be modified by attachment of a derivative of fentanyl, which does not interfere with the formation of active β-galactosidase. However, antibodies to fentanyl bind to the ED-fentanyl conjugate, and block complementation. The assay is based on the competition of fentanyl in a urine sample with the ED-fentanyl conjugate for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the ED-fentanyl conjugate, resulting in inhibition of enzyme formation. As the fentanyl concentration in the sample increases, ED-fentanyl becomes available for complementation, creating a dose response relationship between fentanyl concentration in the urine and enzyme formation. The β-galactosidase activity is determined spectrophotometrically at 570 nm by the conversion of CPRG (orange) to chlorophenolred (red) and galactose.

The Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay is a sensitive in-vitro test to detect the presence of Fentanyl in human urine samples.

Fentanyl is a synthetic narcotic analgesic of high potency and short duration of action. Although 200 times more potent than Morphine, Fentanyl has a high safety margin. 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. 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. Because of the potency of the drug, concentrations encountered in biological fluids are in the sub nanogram range.