Download Document

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]