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NICOTINE TEST -- Cotinine Test -- COTININE TESTING

WHAT IS COTININE?

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, its 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.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 200 ng/mL.

Cotinine Test Device
Description

CAS-COT - Cotinine Test Device

General Description:  Urine Test For Nicotine

This Cotinine Test Device tests for the presence of Cotinine in human urine.

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Directions for How To Use Cotinine Test Devices

FAQ: Cotinine Test Questions and Answers

 

COT

One Step Cotinine Test Device

A rapid, one step test for the qualitative detection of Cotinine (nicotine metabolite) in human urine. For Determination of Smoking Status Only.

Intended 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 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.

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, its 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 200 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 colored line will show up in the test line region. The colored 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 colored 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 colored line will always appear at the control line region indicating that that proper volume of specimen has been added and membrane wicking has occurred.

Reagents

The test device contains mouse monoclonal anti-Cotinine antibody-coupled particles and Cotinine-protein conjugate. A goat antibody is employed in the control line system.

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.

Storage and Stabliity

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE.  Do not use beyond the expiration date.  The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed settle to obtain a clear supernatant for testing.

Specimen Storage

Urine specimens may be stored at 2-8C for up to 48 hours prior to assay. For prolonged storage, specimens may be frozen and stored below -20C. Frozen specimens should be thawed and mixed before testing.  

Materials Required Buy Not Provided

Specimen collection container

Timer

 

Directions For Use

How To Use Cotinine Test Devices

 

Allow test device, urine specimen to reach room temperature (15-30C) prior to testing.

1.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.

2.Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100 L) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below.

3.Wait for the colored line(s) to appear. The result should be read at 5 minutes. It is important that the background is clear before the result is read. 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 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 device. If the problem persists, discontinue using the lot immediately and contact your local distributor.

Quality Control

A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique. 

Limitation

1.The COT One Step Cotinine Test Device (Urine) provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.1,2

2.It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.

3.Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.

4.A positive result indicates only that the presence of Cotinine is above the cut-off concentration.  It does not indicate or measure level of consumption.

 

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Cotinine Testing Questions & Answers

Questions

Answers

What is cotinine?

 Cotinine [COAT-e-neen] is a chemical that is made by the body from nicotine, which is found in cigarette smoke. Since cotinine can be made only from nicotine, and since nicotine enters the body with cigarette smoke, cotinine measurements can show how much cigarette smoke enters your body.

 Is cotinine harmful?

 As far as we know, cotinine itself is not harmful. Cotinine is used simply to measure how much tobacco smoke has entered your body. However, many studies show that some of the 4,000 other chemicals found in tobacco smoke are harmful.

 Why should I have a cotinine test?

 If you are serious about stopping or reducing your smoking, or if you are interested in the amount of smoke that has entered your body, this test can be very useful. By knowing what your starting level of cotinine is, you can see how successful your efforts to stop smoking are.

 How is cotinine measured?

 Our Cotinine test is a simple at home test that can measure cotinine in human urine.

 Why don't you just ask how much I smoke?  Or just keep track?

 Smoking behavior varies. For example, two people could each smoke a pack of cigarettes a day. One may smoke unfiltered cigarettes, inhaling deeply with each puff, while the other may smoke a low tar, filtered cigarette, puffing lightly and smoking only half of each cigarette. The cotinine test would be able to show a difference in the amount of cigarette smoke entering the bodies of these two smokers.

 How much cotinine is normal?

 People who do not smoke or who are not exposed to other peoples' smoke should not have measurable cotinine. People who do smoke will have a cotinine level of 10 or higher in their blood, and a typical smoker has levels of 150 to 450 units. Levels in urine are ten times higher.

 How can I reduce my cotinine?

 The only way to reduce your cotinine level is to stop or reduce your exposure to cigarette smoke.

 How long should it take for me to see a drop in my cotinine level if I stop smoking today?

 Depending on how high your level is to begin with, your level could drop to that of a nonsmoker in 7 to 10 days.

 If I stop smoking, then start again, how soon will cotinine show up in my body?

 Our Cotinine test can detect cotinine as soon as one day after you've had a cigarette.

 If I switch to a low nicotine cigarette, will my cotinine level drop?

 It might, but it depends on how you smoke low nicotine cigarettes. To satisfy a craving for nicotine, some people smoke more low nicotine cigarettes than they would regular cigarettes, and their cotinine level may actually increase.

 Do nicotine patches, gum, or aerosols have an effect on cotinine levels?

 Because they all use nicotine, these devices can increase cotinine levels. If you are having a cotinine test, make sure that you mention on the lab slip that you are using nicotine replacement products.

 What about other people's smoke? Won't my cotinine level increase if I breathe other people's smoke?

 If you breathe a lot of cigarette smoke even though you yourself don't smoke, your cotinine level may be higher than that of a non-smoker. If so, you should try to avoid places where there is a lot of smoke.

 How can I stop smoking?

 There are many different ways to stop smoking, but there is no one way that's best for everybody. The cotinine test will help you to measure the success of whatever way you try. Ask your doctor for advice, or contact organizations that are experienced in helping people give up cigarettes.

 

 

 

 

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