Salimetrics Salivary Cotinine Assay Now Available as an In-Vitro Medical Device

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Now medical professionals and researchers who need assessments of exposure to nicotine from tobacco products can be assured of highly accurate and reliable results from the Salimetrics High Sensitivity Salivary Cotinine EIA Kit.

The Salimetrics High Sensitivity Salivary Cotinine EIA Kit is now offered as an in-vitro medical device and available for use in clinical settings as a test for tobacco products use and exposure.

Cotinine levels have routinely been determined by drawing blood samples, but cotinine also passes easily from the bloodstream into saliva, making it possible to monitor tobacco use by a simple saliva collection, eliminating the inconvenience, expense, pain or hazards of a blood draw. Salivary cotinine is therefore frequently preferred by experts in the field for detection of tobacco exposure. (Jarvis et al. 2008) The Salimetrics Cotinine EIA is especially well-suited for this use since its sensitivity is optimized to detect the lower levels of cotinine found in saliva samples. Most other cotinine EIA kits are designed for use with blood or urine samples and then modified for use with saliva.

Likewise, though a number of qualitative salivary cotinine screening devices have been approved for use in assessing tobacco use, they do not have the sensitivity or accuracy required to detect cotinine levels in the low range that usually results from exposure to second-hand smoke or in individuals who smoke only a few cigarettes per day. The Salimetrics Cotinine Immunoassay was designed with a lower limit of sensitivity at 0.15 ng/mL, in order to fill this need. The Salimetrics Salivary Cotinine EIA, when compared to LC-ES/MS/MS, returned a Pearson correlation of 0.90 with a p value of <0.005, n=40.

Numerous studies have shown that smoking and use of oral tobacco products leads to nicotine addiction and to increased occurrence of diseases, including respiratory problems, cancer, and negative health effects in unborn children. Infants and young children who live in homes with smokers are more likely to have developmental and behavior problems or conditions such as asthma, which have been linked to exposure to secondhand smoke. Insurance companies, smoking cessation programs, public health officials, and child development specialists therefore all have a vested interest in accurate determination of exposure to tobacco products.

Now that clean air legislation is in place in countries such as the U.S. and the U.K., average cotinine values in non-smokers have been dropping, making necessary the lowering of the cotinine cut-off levels that are used to distinguish smokers from non-smokers. Additionally, studies have revealed differences in cotinine levels among different racial groups, which have led to the creation of separate, lowered cut-off levels in order to optimize the ability to distinguish smokers from non-smokers in different populations. (Benowitz et al. 2009) The high sensitivity and reliability of the Salimetrics Salivary Cotinine Immunoassay make possible these sorts of fine distinctions.


Jarvis, M.J., Fidler, J., Mindell, J., Feyerabend, C., & West, R. (2008). Assessing smoking status in children, adolescents and adults: Cotinine cut-points revisited. Addiction, 103(9), 1553-61.

Benowitz, N.L., Bernert, J.T., Caraballo, R.S., Holiday, D.B., & Want, J. (2009). Optimal serum cotinine levels for distinguishing cigarette smokers and nonsmokers within different racial/ethnic groups in the United States between 1999 and 2004. Am J Epidemiol, 169(2), 236-48.

About Salimetrics:

Founded in 1998, Salimetrics, LLC supports researchers, the immunodiagnostic industry, and functional testing laboratories around the world with innovative salivary immunoassay products and services. Salimetrics’ assay kits and CLIA-certified testing services measure biomarkers related to stress, behavior and development, inflammation, and immune function, including: alpha-amylase, androstenedione, blood contamination, chromogranin A, cortisol, cotinine, C-reactive protein, DHEA, DHEA-S, estradiol, estriol, estrone, IL-1b, IL-6, melatonin, progesterone, 17α-hydroxyprogesterone, secretory IgA, testosterone, and TNF-a. Salimetrics also provides salivary DNA analysis. The company is based in State College, Pennsylvania, with offices in the UK and distributors in Europe, Australasia, and South America.

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Chris Schwartz
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