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One Step Cotinine Test Device

A rapid, one step test for the qualitative detection of Cotinine (nicotine metabolite) in human urine. For Determination of Smoking Status Only.

Intended Use

The COT One Step Cotinine Test Device (Urine) is a lateral flow chromatographic immunoassay for the detection of Cotinine in human urine at a cut-off concentration of 200 ng/mL. This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert.

This assay 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 and mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Summary

Cotinine is the first-stage metabolite of nicotine, a toxic alkaloid that produces stimulation of the autonomic ganglia and central nervous system when in humans. Nicotine is a drug to which virtually every member of a tobacco-smoking society is exposed whether through direct contact or second-hand inhalation. In addition to tobacco, nicotine is also commercially available as the active ingredient in smoking replacement therapies such as nicotine gum, transdermal patches and nasal sprays. In a 24-hour urine, approximately 5% of a nicotine dose is excreted as unchanged drug with 10% as cotinine and 35% as hydroxycotinine; the concentrations of other metabolites are believed to account for less than 5%.