NicAlert - Quantitative Instant Saliva Professional Nicotine Test + Second Hand Smoke

Sales Price: $17.25

NicAlert™ is a simple, cost-effective test to determine smoking status of a person. It is an easy-to-read test strip that can be used with a saliva sample (urine version is also available)

NicAlert™ can help:

health care professionals to test for their patient's exposure to tobacco smoke

teachers and high school coaches to test high school athletes for smoking or other tobacco product use;

to verify smoking status for insurance applications;

to test subjects in tobacco research studies.

There are many new significant opportunities for the development and expansion of state-funded research and tobacco prevention and cessation programs.

INTENDED USE
NicAlert™ is intended for in vitro diagnostic professional use for the semi-quantitative determination of cotinine in saliva for the purpose of determining if an individual has been exposed to tobacco products such as cigarettes, pipes, or chewing tobacco within the past 48 hours.

The cutoff concentration for the NicAlert™ test is 100 ng/mL. Second hand smoke exposure (environmental tobacco smoke) may cause a positive result in a non-user of tobacco products. The NicAlert™ Positive and Negative Controls are intended for in vitro diagnostic use for the quality control of the NicAlert™ test.

BACKGROUND
The knowledge and awareness of the health hazards associated with exposure to tobacco products, especially smoking cigarettes, is well established.(FN 1-8) Cigarette smoking has been identified as one of the most significant causes of death and disease in the U.S. (Surgeon General's Report of the U.S. Public Health Service, Year 2000). Smoking has been cited as being responsible for 87% of deaths from lung cancer, 21% of deaths from coronary heart disease, 18% of deaths from stroke, and 82% of deaths from chronic obstructive pulmonary disease. Significantly elevated risks of disease and death are also associated with other forms of tobacco use such as pipe and cigar smoking and the use of chewing tobacco.As an adjunct to self-reporting of smoking behavior, and as a more objective approach, the assay of biochemical markers is of established importance. Urinary nicotine is not a reliable indicator of smoking status as it has a comparatively short half-life.9 Cotinine is a major metabolite of nicotine and it has a relatively long half-life (10-40 hours). Cotinine has been shown to be more sensitive and specific than CO monitoring for measuring smoking status.(FN 9-13) The reference method used for measuring cotinine is Gas Chromatography/Mass Spectrometry (GC/MS)(FN 14), or Liquid Chromatography / Mass Spectrometry (LC/MS/MS).(FN 15)

PRINCIPLE OF THE TEST
NicAlert™ is an immunochromatographic assay that uses monoclonal antibody-coated gold particles and a series of avidity traps that allow quantification. It employs patented technologies, (U.S. Patent Nos. 5,527,686; 5,710,009; 6,087,185 and 6,121,008). The sample collection end of the strip contains gold particles coated with monoclonal antibodies to cotinine, a relatively long-lived metabolite of nicotine. The distance the gold migrates on the strip is shown by a clear color change and provides an accurate measure of the amount of cotinine in the sample.

MATERIALS PROVIDED
1. NicAlert™ Strip:
Each NicAlert™ test strip is individually packaged in a sealed labeled plastic pouch.

Each test strip is composed of the following:

A. 5mm X 90mm nitrocellulose impregnated with:

i. Mouse monoclonal antibodies reactive to cotinine, conjugated to colloidal gold particles.
ii. Rabbit anti-mouse polyclonal antibodies reactive to mouse antibodies.
iii. 1% Cobalt Blue 406 #2 dye.
iv. Carboxycotinine, isopropyl carboxynorcotinine, carboxyphenylethylcotinine bromide.
v. 50mM sodium phosphate buffer pH 7.2, bulking agents, stabilizers.


B. Cotton pads, filters.

2. Controls:

A. NicAlert™ Negative Control (cotinine 0 ng/mL) B. NicAlert™ Low Positive Control (cotinine 400 ng/mL) C. NicAlert™ High Positive Control (cotinine 2000 ng/mL)

The NicAlert™ Positive and Negative Controls are human saliva-based liquid and are ready to use. These Controls each contain a known concentration of cotinine (Negative: 0 ng/mL; Low Positive: 400 ng/mL; High Positive: 2000 ng/mL). The NicAlert™ Positive Control is prepared by spiking known concentrations of cotinine into the NicAlert™ Negative Control, which is preserved human saliva with no detectable amount of cotinine by LC/MS/MS. Negative Control human saliva is tested negative for human pathogens (including HBV, HCV, HIV). The nominal concentrations of cotinine in the NicAlert™ Controls are determined and confirmed by LC/MS/MS. See vial labels for expiration date and for opened and closed vial stability.

Materials Required But Not Provided:
A timer or clock.

For saliva sample collection a clean, leak-proof, disposable container (saliva specimen container) is required. For saliva samples, latex or rubber gloves are needed for saliva collection, and forceps, tweezers or gloves are preferred for holding the strip when dipping it into the saliva sample.

Store NicAlert™ at room temperature, out of direct sunlight, in the sealed pouches. The test strips can be used up until the expiration date indicated on the label. Once the package is opened, the strip should be used within 10 minutes. NicAlert™ Positive and Negative Controls should be stored at 2°-8°C. After opening, do not use the Controls if the contents become cloudy or altered in appearance.

Do not put any part of the NicAlert™ strip in your mouth.

Treat samples as a potential biohazard and discard appropriately after testing.

Use the NicAlert™ strip within 10 minutes of opening the pouch.

Discard any samples if contamination is suspected and obtain another sample.

Do not consume or handle food or drink near the NicAlert™ strip or when performing the test.

Test samples at room temperature.

WARNING: NEVER PLACE A NicAlert™ STRIP IN YOUR MOUTH

QUALITY CONTROL
Good laboratory practice recommends periodic use of quality control procedures. It is recommended that the NicAlert™ Human saliva Positive and Negative Test Controls be run at least once per day when clinical specimens are tested. The use of controls from other commercial vendors is also recommended. Users should follow the appropriate federal, state and local guidelines concerning the running of external quality controls. The NicAlert™ Positive and Negative Test Controls are intended for in vitro diagnostic use for the quality control of the NicAlert™ test. The NicAlert™ Negative Controls consist of cotinine-free (NicAlert™ Level "0") human preserved pathogen-free saliva. The NicAlert™ Positive Controls consists of cotinine-free saliva spiked with cotinine to concentrations of 400 ng/mL cotinine (Low Positive Control, NicAlert™ level "4") and 2000 ng/mL cotinine (High Positive Control, NicAlert™ level "6").

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