*Statement on Forensic Use Products
Forensic Use Only devices are intended for use only in drugs of abuse testing for law enforcement purposes.
Appropriate users of such devices include, for example, court systems, police departments, probation/parole offices, juvenile detention centers, prisons, jails, correction centers and other similar law enforcement entities, or laboratories or other establishments performing forensic testing for these entities.
Forensic Use Only devices are not designed, tested, developed, or labeled for use in other settings, such as clinical diagnostic or workplace settings.
The DRI® Fentanyl Enzyme Immunoassay is intended for the qualitative determination of Fentanyl in human urine.
This assay provides only a preliminary analytical test result. A more specifi c alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) and Liquid Chromatography/tandem mass spectrometry are the preferred confi rmatory methods.
The DRI Fentanyl Assay is supplied as liquid ready-to-use homogeneous enzyme immunoassay.
The assay uses fentanyl specific monoclonal antibody that can detect fentanyl without any significant cross-reactivity to other opiate compounds. The assay is based on competition between a drug labeled with glucose-6-phosphate dehydrogenase (G6PDH), and free drug from the urine sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specifi c antibody binds the drug labeled with G6PDH and causes a decrease in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity. The enzyme activity is determined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.