COT Drug Test

COT Drug Test 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%. 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.

Accuracy

Relative Sensitivity: 99.00% (94.55%~99.98%) Relative Specificity: 100.0% (99.02%~100%)

Overall Agreement:99.79% (98.83%~99.99%) *95% Confidence Interval

Relative Sensitivity:98.89% (93.96%~99.97%) Relative Specificity: 95.83% (91.15%~98.46%)

Overall Agreement:99.28% (96.06%~99.98%) *95% Confidence Interval

Analytical Sensitivity

A drug-free urine pool was spiked with Cotinine at the following concentrations:600ng/mL,300ng/mL,250ng/mL,200ng/mL,150ng/mL,100ng/mL, and 0 ng/mL. The result demonstrates 100% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:

Analytical Specificity

The following table lists compound and their respective concentrations in urine that yield a positive result in the Cotinine (COT) Rapid Test at 5 minutes.

Precision

Intra-Assay

Assays were carried out to determine assay reproducibility using replicates of 20 tests in three different runs for each of three lots using COT specimen levels at 0 ng/mL, 200 ng/mL(cut-off) and 250 ng/mL(+50% cut-off). The specimens were correctly identified 98% of the time.

Inter-Assay

Between-run precision has been determined by using the three COT specimen levels at 0 ng/mL, 200 ng/mL(cut-off) and 250 ng/mL(+50% cut-off) of COT in 3 independent assays. Three different lots of the Cotinine (COT) Rapid Test have been tested using these specimens. The specimens were correctly identified 98% of the time.

Effect of Urinary Specific Gravity

The urine samples of different specific gravity ranges (1.000-1.037) were spiked with drugs at 25% below and 25% above cut-off levels respectively. The Cotinine (COT) Rapid Test was tested in duplicate using fifteen drug-free urine and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity do not affect the test results.

Effect of Urinary pH

The pH of an aliquoted negative urine pool was adjusted to a pH range of 3 to 9 in 1 pH unit increments and spiked with drugs at 25% below and 25% above cut- off levels. The spiked,pH-adjusted urine was tested with the Cotinine (COT) Rapid Test. The results demonstrate that varying ranges of pH do not interfere with the performance of the test.

Each test consists of a reagent strip . The amount of each antigen and/or antibody coated on the strip is less than 0.001 mg for antigen conjugates and goat anti-mouse IgG antibodies, and less than 0.0015 mg for antibody components. The control zone of each test contains goat anti-mouse IgG antibody. The test zone of each test contains drug-bovine protein antigen conjugate, and the conjugate pad of each test contains monoclonal anti-drug antibody and mouse antibody-colored particle complex.