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Validation of Self-Reported Smoking Status Using Saliva Cotinine: A Rapid Semiquantitative Dipstick Method

¹ Acordia National/Wells Fargo, Charleston, West Virginia and ² Clinical Research Centers of Tennessee, PLLC, Lebanon, Tennessee

Requests for reprints: Norman J. Montalto, Acordia National/Wells Fargo, 602 Virginia St. E., Charleston, West Virginia, 25327-1921. Phone: 800-936-9669; Fax: 514-332-2227. E-mail: norman.montalto{at}gwl.com

Purpose: This study evaluated the performance characteristics of a novel rapid method for verifying smoking status in individuals by measurement of cotinine, the primary metabolite of nicotine, in saliva samples using an immunochromatographic strip in a "dipstick" format compared with liquid chromatography/mass spectrometry (LC/MS).

Materials and Methods: A prospective comparison was made of smoking status as determined by measurement of cotinine in urine by LC/MS (the gold standard) and in saliva using a semiquantitative dipstick assay that uses cotinine-specific monoclonal antibodies attached to gold particles and a series of avidity traps to measure cotinine levels (saliva NicAlert®). One hundred seventy-two individuals from a family practice/general medical setting agreed to participate after informed consent and institutional review board approval. Saliva NicAlert® tests were done by untrained operators who followed written directions.

Results: Comparison of smoking status as determined by urine cotinine measurement by LC/MS (50 ng/mL cutoff) with the saliva strip test results, averaged over the two operators, indicated that the saliva test strip results had a sensitivity of 99% and a specificity of 96%. Saliva NicAlert® also identified four smokers who reported being nonsmokers but were confirmed to be smokers by LC/MS.

Conclusions: The saliva NicAlert® assay seems to be a valid, highly sensitive, and specific method for validating self-reported smoking status and may have clinical applications in selected medical settings. (Cancer Epidemiol Biomarkers Prev 2007;16(9):1858–62)