DOA COT One Step Cotinine Rapid Test with CE certificate urine Uncut sheet

One Step Cotinine Test is a rapid one step test for the qualitative detection of cotinine, which is the principal metabolites nicotine, in human urine at specified cut-off level.

For healthcare professional use only. For in vitro diagnostic use only.

INTENDED USE

The One Step Cotinine Test is a lateral flow chromatographic immunoassay for the detection of cotinine at the cut-off level of 100 ng/ml.

The assay is intended to verify an intoxication in patients. It provides a qualitative, preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/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 results are positive.

Test must be in room temperature (15ºC to 30ºC)

PERFORMANCE CHARACTERISTICS

A. Sensitivity

One Step Cotinine Test has set the screen cut-off for positive specimens at 100 ng/mL for cotinine as the calibrators. The test device has been proved to detect above the cut-off level of the target drugs in urine at 5 minutes.

B. Specificity and cross reactivity

To test the specificity of the test, the test device was used to test cotinine and other components of the same class that are likely to be present in urine, All the components were added to drug-free normal human urine. These concentrations below also represent the limits of detection for the specified drugs or metabolites.

Component Concentration (ng/ml)

C. Interfering substances

Considering the complexity of clinical urine specimens and the possibility that various urine specimens contain potentially interfering substances, for example Acetaminophen, Biotin, Glucose etc., we simulated above situations by adding the potentially interfering substances to a certain concentration as specimen. The following components show no cross-reactivity when tested with One Step Cotinine (COT) Test at a concentration of 100 mg/ml.

SUMMARY

Cotinine is an alkaloid found in tobacco and is also a major metabolite of Nicotine, which produces stimulation of the autonomic ganglia and central nervous system when in humans. Nicotine is found in tobacco products such as cigarettes, tobacco chew, and nicotine patches or gums. It is an addictive substance and is poisonous in a large amount. In addition to addiction, some of the other substances within tobacco products, such as carbon monoxide or tar, are dangerous to the body and can lead to medical conditions such as emphysema, lung cancer, and heart disease. 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, its elimination profile is more stable than that of Nicotine which is largely urine PH dependent. Cotinine is stable in body fluids and has a relatively long half-life of approximately 17 hours, and is typically detectable for several days (up to one week) after the use of tobacco, therefore the detection of Cotinine is less dependent on the time of sampling than that of Nicotine.

Nicotine and Cotinine are rapidly eliminated by the kidney; the window of detection for cotinine in urine at a cut-off level of 100 ng/mL is expected to be up to 2-3 days after nicotine use.