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The DRI® Cotinine Enzyme Immunoassay is intended for the Qualitative and Semi-Quantitative determination of Cotinine in human urine at a cutoff level of 500 ng/mL. This assay is intended for in vitro diagnostic use only. The assay is intended as an aid in the detection of cotinine after use or exposure to tobacco products.

The DRI® Cotinine EIA Assay is a liquid ready-to-use homogeneous enzyme immunoassay. The assay uses specific antibodies, which can detect cotinine drugs in urine. The assay is based on competition between a drug labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme, 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 causing a decrease in enzyme activity. This phenomenon creates a direct relationship between drug concentration in urine and enzyme activity. The enzyme G6PDH activity is determined spectrophotometrically at 340 nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.

NicAlert™ is intended for in vitro diagnostic professional use for the semiquantitative determination of cotinine in urine for the purpose of determining if an individual has been exposed to tobacco products such as cigarettes, pipes, or chewing tobacco within the past 48 hours. The cutoff concentration for the NicAlert™ test is 100 ng/mL. Second hand smoke exposure (environmental tobacco smoke) may cause a positive result in a non-user of tobacco products. The NicAlert™ Positive and Negative Controls are intended for in vitro diagnostic use for the quality control of the NicAlert™ test.

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