*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 Thermo Scientific DRI Ethyl Glucuronide Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of Ethyl Glucuronide in human urine at cutoffs of 500 ng/mL and 1000 ng/mL.
This assay provides only a preliminary analytical test result. A more specifi c alternative method must be used in order to obtain a confi rmed analytical result. Gas Chromatography/Liquid chromatography mass spectrometry (GC/MS) and Liquid chromatography/tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods.
The DRI® Ethyl Glucuronide Assay is supplied as a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies that can detect Ethyl Glucuronide without any significant cross-reactivity to other glucuronide 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 specific 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. Active enzyme converts NAD to NADH resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.