The DRI® Hydrocodone Assay is intended for the qualitative and semi-quantitative detection and estimation of Hydrocodone and its metabolites in human urine at a cutoff of 300 ng/mL. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of specimen for confi rmation by a confi rmatory method such as LC-MS/MS or GC-MS and permitting laboratories to establish quality control measures. This assay provides a preliminary analytical test result. A more specifi c alternative chemical method must be used in order to confi rm an analytical result. Gas chromatography/mass spectrometry (GC/MS) and Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) are the preferred confi rmatory methods.1 Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. Rx Only.
The DRI Hydrocodone Assay is supplied as a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibody that can detect Hydrocodone and its metabolites. 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 fi xed amount of specifi c 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. In the presence of free drug, the free drug occupies the antibody binding sites, allowing the drug bound G6PDH to interact with the substrate, resulting 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.