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NANO-DITECH CORPORATION NANO-CHECKTM RAPID NICOTINE TEST Nicotine Market Insurance Company : The insurance company runs Nicotine test to the applicant for medical and/or life insurance policy to determine if the person smokes or not. They do this because insurance cost is higher for the smokers. Different insurance company have different rate schedule but the increase is around 30%. Most of the insurance company offers two rating categories for cigarette smokers and two rating categories for users of other nicotine products. Based on these below categories the rate varies. Cigarette Smoker Categories • Preferred Smoker – cigarette use current or within 12 months • Smoker – cigarette use current or within 12 months Users of Other Nicotine Products Categories • Non-Smoker Plus – no cigarette use for 12 months • Non-Smoker – no cigarette use for 12 months Nicotine Market (continued) Company : Some employers encourage employees to make smoke-free environment because use of tobacco products can greatly affect the health of individuals, companies may use nicotine/cotinine testing to evaluate prospective employees for tobacco use. School : Public/Private school provide random nicotine test to the student to prevent under age smoking. Some professional school are testing nicotine test on the applicant for admission. Government : Nicotine tests are also used for research, surveys, campaigns, programs etc. Latest Tobacco Trends Global cigarette consumption has been rising steadily since James Bonsack invented the first cigarette-rolling machine in 1881. By the 1960s, the incontrovertible health consequences of smoking had become apparent. In some countries, consumption began leveling off and even decreasing. Worldwide, however, more people are smoking. The total number of smokers is increasing mainly due to expansion of the world’s population: by 2030, the planet will support 2 billion more people than in 2000. Unless smoking prevalence rates decline dramatically, the absolute number of smokers will continue to increase. Escalating global consumption of tobacco products has created an unprecedented global public health emergency, a pandemic of epic proportions. Latest Tobacco Trends (continued) Health Effect of Tobacco Use • Smoking is the most important preventable cause of premature death and ill health in the world. It is an undisputed fact that the use of nicotine products will, most likely, affect a person’s health. There are no safe tobacco products. The use of any tobacco product (including cigarette, cigar, pipe, and spit tobacco) can cause cancer and other adverse health impairments. •The principal causes of death among cigarette smokers are ischemic heart disease and cancer of the lung and bronchus. At least 20% of all heart disease deaths are smoking related. •The body changes nicotine to cotinine prior to being excreted as waste product. Because nicotine has a short existence in its natural form in the body, cotinine testing extends the window of detection for several days, making it the preferred method of screening for tobacco use. Health Effect of Tobacco Use (continued) • Cigarette smoking leads to serious health problems, including cough and phlegm production, an increase in the number and severity of respiratory illnesses, decreased physical fitness(both performance and endurance), adverse changes in blood cholesterol levels, and reduced rates of lung growth and function. • Studies that compare smoking and non-smoking populations show that those who smoke cigarettes experience roughly twice the mortality of non-smokers. After smoking cessation, excess mortality will decrease, but it depends on how long an individual smoked, the amount of cigarettes smoked daily, and the amount of damage already done. For example, “light” smokers (i.e. less than 20 cigarettes daily) who stop and are then followed for 10 years eventually reach a mortality similar to non-smokers. However, mortality remains high for those who smoked for a long period of time or who were “heavy” smokers. What’s in a Cigarette? • 4,500 quemicals including ammonia, formaldehyde, acetone, arcesic, lead, hydrazine, etc •Nicotine – a powerful mood altering substance that is more addictive than heroin and cocaine. •Tar – a dark, sticky combination of hundreds of chemicals including poisons and cancer-causing substances. Smoking one pack a day will deposit a pint of tar in your lungs within one year. •Carbon Monoxide – a deadly poisonous gas. Different Types of Tobacco • Hookah : Hookah tobacco contains the same chemicals found in all tobacco including Nicotine. Hookah users ingest about 100 times more lead from hookah smoke than from a cigarette. • Cloves/Bidis : One bidi produces more than three times the amount of carbon monoxide than a cigarette and contains three times the amount of nicotine and tar than one cigarette. • Cigars : Cigar smoking increases the risk of death from cancer of the larynx more than 10 times and cancer of the oral cavity/pharynx by four times. • Smokeless Tobacco : A single can of smokeless tobacco contains 3-5 times the amount of cancer-causing chemicals than in a pack of cigarettes. The amount of nicotine absorbed from dipping 8-10 times is the equivalent of smoking 30-40 cigarettes. Difference Between Nicotine & Cotinine •The metabolites of nicotine that gets accumulated in the body fluids are nicotine isomethonium ion, nicotine glucuronide, nornicotine, nicotine N’-oxide, 2-hydroxynicotine and cotinine. Among these cotinine is the major metabolite affecting the body. Usually a cigarette is found to contain around 1 mg of nicotine which means that just a pack of cigarette contains around 20 mg of nicotine. •The body changes nicotine to cotinine prior to being excreted as waste product. Because nicotine has a short existence in its natural form in the body, cotinine testing extends the window of detection for several days, making it the preferred method of screening for tobacco use. •All forms of tobacco contain abundant nicotine. Its detection indicates that the individual has recently consumed a significant quantity of tobacco. The most common argument, when a proposed insured tests cotinine positive, is passive smoke or second hand smoke exposure from a family member or coworker. Studies show that most individuals who are heavily exposed to second hand smoke do, in fact, have measurable quantities of nicotine/cotinine in their urine. For this reason, laboratories set thresholds for a “positive” cotinine test significantly higher than what is seen for passive exposure. Nicotine Metabolism • Nicotine is extensively metabolized to a number of metabolites in liver. • Humans, about 70 to 80% of nicotine is converted to cotinine. •This transformation involves two steps. The first is mediated by the cytochrome P450 system (mainly CYP2A6 and CYP2B6) to produce nicotine iminium ion. •The second step is catalyzed by aldehyde oxidase (AOX). Nicotine N'-oxide (NNO) is another primary metabolite of nicotine, although only about 4-7% of nicotine absorbed by smokers is metabolized via this route. Nicotine Metabolism (continued) •Recent in vitro experiments suggest that UGT2B10 may be the primary enzyme in liver responsible for this conversion and that gene polymorphisms may influence this. About 3-5% of nicotine is converted to Nicotine-Gluc and excreted in urine in humans. •A number of cotinine metabolites have also been structurally characterized. Indeed, it appears that most of the reported urinary metabolites of nicotine are derived from cotinine. •3'-Hydroxycotinine (3HC) is the main nicotine metabolite detected in smokers' urine. It is also excreted as a glucuronide conjugate (3HC-Gluc). 3HC and 3HC-Gluc account for 40-60% of the nicotine dose in urine. NANO-CHECKTM NICOTINE TEST • In order to find out the traces of nicotine in your body as well as to know how long does nicotine stay in urine, one needs to undergo a urinal drug test or urinalysis which is based on the immuno-chromatographic assay technology which detects the samples of such addictive products in urine. For those who smoke occasionally, nicotine persists in the body for only 3-4 days only. But for those who are passive smokers the traces of nicotine can be found for as long as 15-20 days. •The physiological concentrations of cotinine detected in saliva and plasma of nonsmokers typically range from 0.5ng/ml to 15ng/ml, and urinary concentrations range to 50ng/ml or higher level. • NANO-CHECKTM RAPID NICOTINE TEST is a rapid, self-controlled, immunoassay for the qualitative detection of Cotinine in human urine. The detection limit concentration (Cut off) of this test is Cotinine at 200ng/ml or 500ng/ml. This assay is intended for professional and in-vitro use only. Principle of the Test • The NANO-CHECKTM RAPID NICOTINE TEST device contains a membrane strip on which monoclonal antibody against cotinine is immobilized on the test line. The colored indicator, drug conjugate coupled with Gold colloidal particles is placed at the end of membrane. •When the test urine is applied on the sample well of the device, the colored indicator particles move along with sample urine across membrane by the capillary action. •If cotinine in urine specimen, it competes with colored indicator drug conjugates for the limited amount antibodies immobilized on the membrane. •If equal or more than cut off level amount of cotinine is present in the sample urine, the cotinine will prevent the binding of drug conjugate to the target antibody. Procedure of the Test 1. Remove the test device from the sealed pouch immediately before use 2. Put 80 ul of urine sample using enclosed dropper or pippette into the sample well 3. Wait 5 to 10 min for the result Interpretation of the Results Negative Positive Invalid Negative: Two colored lines will appear. The line in the test region (T) is the drug probe line; the line in the control region (C) is the control line, which is used to indicate proper performance of the device. The color intensity of the test line may be weaker or stronger than that of the control line. Negative result does not indicate that the absolute absence of drugs in specimen, it only indicates the specimen does not contain the drug at a concentration equal or above the cut off level in qualitative terms. Positive: One colored line appears on the control region (C), the absence of test line (T) is a presumptive positive result for cotinine; i.e. the specimen may contain cotinine or its analogous compounds at concentration above the cutoff level. Invalid: If no colored line in the control region, the test result is invalid. Under no circumstance should a positive sample be identified until the control line appears in the viewing area. If the colored line does not appear, the test result is inconclusive and the assay should be repeated with a new test device. Sensitivity The Nano-CheckTM Rapid Nicotine test detects cotinine in human urine at the cut-off concentrations of 200ng/ml or 500ng/ml. The cutoff value was determined using control urines spiked with the specified compounds at the indicated concentration; 25%, 50 % below cut off level, and 25%, 50% above cut off level. Cotinine Level (ng/ml) Negative. Positive Coincidence (%) 100 25 0 100 150 25 0 100 200 15 10 N/A 250 4 21 84 500 15 10 N/A Accuracy The Nano-CheckTM Rapid Nicotine test detects cotinine in human urine at the cut-off concentrations of 200ng/ml or 500ng/ml. The cutoff value was determined using control urines spiked with the specified compounds at the indicated concentration; 25%, 50 % below cut off level, and 25%, 50% above cut off level. GC/MS Results Nano-CheckTM Rapid Nicotine Result Positive Negative Total Positive 49 0 49 Negative 1 100 101 Total 50 100 150 98.0 % 100 % 99.3 % Agreement Specificity & Cross Reactivity The following compounds were tested to determine cross reactivity at the cut off concentration of target drug with Nano-CheckTM Rapid Nicotine test. Compounds Nano-CheckTM Rapid Nicotine Result Cutt-off (ng/ml) Cross Reactivity Cotinine 200 100 Nicotine > 100,000 < 0.2 Niacinamide > 100,000 < 0.2 Nicotinic Acid > 100,000 < 0.2 Thank you for your attention Contact Pammvi Group of Companies for more information about pricing and availability C 501 Remi Bizcourt Off Veera Desai Andheri West Mumbai 400053 India Telephone nos 91 22 26731904 / 26731052 / 26732760 Fax 91 22 26731901 Website www.pammvi.com email id [email protected]