A rapid test for the qualitative detection of Cotinine (nicotine metabolite) in human Whole Blood /Serum/Plasma CE certified
The COT Rapid Test Cassette (WB/S/P) is a rapid 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.
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 whole blood or serum or plasma, approximately 5% of a nicotine dose is excreted as unchanged drug with 10% as cotinine and 35% as hydroxy cotinine; the concentrations of other metabolites are believed to account for less than 5%.1 While cotinineis thought to be an inactive metabolite, it’s elimination profile is more stable than that of nicotine which is largely whole blood whole blood/serum/plasma 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 whole blood or serum or plasma at a cutoff level of 10ng/ml or 100ng/ml is expected to be up to 2-3 days after nicotine use.
The COT Rapid Test Cassette (whole blood/serum/plasma) is a rapid whole blood/serum/plasma-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 whole blood or serum or plasma. The COT Rapid Test Cassette (whole blood/serum/plasma) yields a positive result when the Cotinine in whole blood or serum or plasma exceeds the cut-off level (10ng/ml or 100ng/ml).
How to use?
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
For serum or plasma specimen:
1. Bring the pouch to room temperature (15-30℃) before opening it. Remove the cassette from the sealed pouch and use it within one hour.
2. Place the cassette on a clean and level surface. Hold the dropper vertically and transfer 1 full drop of serum or plasma (approximately 40μl), then add 2 drops of buffer (approximately 80μl) to the specimen well of the cassette, and then start the timer. Avoid trapping air bubbles in the specimen well. See illustration below.
3. Wait for the colored line(s) to appear. Read the result at 5 minutes. Do not interpret the result after 10 minutes.
For whole blood specimen:
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 1 drop of whole blood (approximately 40μl) to the specimen well, then add 2 drops of buffer (approximately 80μl), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 40μl of fingerstick whole blood specimen to the specimen area of test cassette, then add 2 drops of buffer(approximately 80ul) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two lines appear. One colored line should be in the control line region (C), and another apparent colored line should be in the test line region (T). This negative result indicates that the Cotinine concentration is below the detectable level (200 ng/mL).
*NOTE: The shade of color in the test line region (T) may vary, but it should be considered negative whenever there is even a faint colored line.
POSITIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). This positive result indicates that the Cotinine concentration exceeds the detectable level (200 ng/mL).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test. If the problem persists, discontinue using the lot immediately and contact your local distributor.