Package Insert
description
The Accutest Saliva Cotinine Test is a lateral flow chromatographic immunoassay for the qualitative detection of cotinine in oral fluids at a cut-off concentrations of 30 ng/mL.
The Accutest Saliva Cotinine Test is a rapid, oral fluid screening test that can be performed without the use of an instrument. The test utilizes antibodies to selectively detect elevated levels of specific drugs in human oral fluid.
Cotinine is the first-stage metabolite of nicotine, a toxic alkaloid that stimulates the autonomic ganglia and central nervous system 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. Aside from tobacco, nicotine is also commercially available as the active ingredient in smoking replacement therapies such as nicotine gum, transdermal patches and nasal sprays.
*This product can be used by CLIA Waived facilities.
PRELIMINARY POSITIVE: A colored line in the control line region (C) but no line in the test line region (T) for a specific drug indicates a positive result. This indicates that the drug concentration in the oral fluid specimen exceeds the designated cut-off for that specific drug.
NEGATIVE: A colored line in the control line region (C) and a colored line in the test line region (T) for a specific drug indicates a negative result. This indicates that the drug concentration in the oral fluid specimen is below the designated cut-off level for that specific drug.
INVALID: Control line (C) fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure.
*This test provides only a preliminary result. A more specific alternative chemical method should be used to obtain a confirmed presumptive positive result if the donor doesn’t admit use or anytime required by testing procedures. Gas Chromatography/ Mass Spectrometry (GC-MS), Liquid Chromatography/ Mass Spectrometry (LC-MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drug screen test result, particularly when evaluating preliminary positive results.
CLIA WAIVED RAPID TESTS
CLIA LABORATORY
6320 Canoga Ave. Ste. 1500, FL 15
Woodland Hills, CA 91367
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