Transcription of Status DS Nicotine 58113-C - LifeSign LLC
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Status DS NicotineOne-Step Nicotine TestFor Laboratory In Vitro Use OnlySimple One-Step Immunoassay for the Qualita-tive Detection of Nicotine Metabolite in UrineStock Test Kit2171010 Test KitIntended UseThe Status DS Nicotine test is a simple, one-step, immuno-chromato-graphic assay for the rapid, qualitative detection of cotinine, a majormetabolite of Nicotine , at the cut-off of 500 ng/mL in human urine. StatusDS Nicotine is used as an aid in the detection of cotinine after use oftobacco products or other products containing Nicotine . For In vitroDiagnostic UseTheStatus DS Nicotinetest provides only a preliminary analytical more specific alternative chemical method must be used in order to obtaina confirmed analytical result. Gas chromatography, mass spectrometry(GC/MS) is the preferred confirmatory and ExplanationSmoking has been identified as a major risk factor for lung cancer andcardiovascular ,2 Self-reporting of smoking Status is not detection of cotinine, a major metabolite of Nicotine , has become thepreferred biomedical method of assessing the smoking Status of individualson account of its sensitivity and is present in blood, urine, and saliva of individuals
Table 1. Status DS™ Nicotine test vs an EIA test Status Nicotine™ Auto-Lyte Cotinine EIA Total Positive Negative Positive 36 0 36 Negative 0 43 43 Total 36 43 79 In a separate study, the accuracy of Status DS™ Nicotine test was evaluated in comparison to the cotinine value of the sample as determined
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