inquiry@rdetect.com 【ntended 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 100 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%.1 While cotinine is thought to be an inactive metabolite, it’s elimination profile is more stable than that of nicotine which is largely urine pH dependent. As a result, cotinine is considered a good biological marker for determining nicotine use. The plasma half-life of nicotine is approximately 60 minutes following inhalation or parenteral administration.2 Nicotine and cotinine are rapidly eliminated by the kidney; the window of detection for cotinine in urine at a cutoff level of 200 ng/mL is expected to be up to 2-3 days after nicotine use.
The COT One Step Cotinine Test Device (Urine) is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Cotinine in urine. The COT One Step Cotinine Test Device (Urine) yields a positive result when the Cotinine in urine exceeds 100 ng/mL.
【Principle】
The COT One Step Cotinine Test Device (Urine) is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Cotinine, if present in the urine specimen below 200 ng/mL, will not saturate the binding sites of antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized Cotinine conjugate and a visible coloured line will show up in the test line region. The coloured line will not form in the test line region if the
Cotinine level exceeds 200 ng/mL because it will saturate all the binding sites of anti-Cotinine antibodies. A drug-positive urine specimen will not generate a coloured line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a coloured line will always appear at the control line region indicating that that proper volume of specimen has been added and membrane wicking has occurred.
【Precautions】
- Do not use after the expiration date.
- The test device should remain in the sealed pouch until use.
- All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
- The used test device should be discarded according to local regulations.
