Urinary Cotinine and Cotinine + Trans-3′-Hydroxycotinine (TNE-2) Cut-points for Distinguishing Tobacco Use from Nonuse in the United States: PATH Study (2013–2014): PATH study (2013-2014)

Kathryn C. Edwards, Tasmia Naz, Cassandra A. Stanton, Maciej L. Goniewicz, Dorothy K. Hatsukami, Danielle M. Smith, Lanqing Wang, Andrea Villanti, Jennifer Pearson, Benjamin C. Blount, Maansi Bansal-Travers, June Feng, Raymond Niaura, Michelle T. Bover Manderski, Connie S. Sosnoff, Cristine D. Delnevo, Kara Duffy, Arseima Y. Del Valle-Pinero, Brian L. Rostron, Colm EverardHeather L. Kimmel, Dana M. van Bemmel, Andrew Hyland

Research output: Contribution to journalArticlepeer-review

13 Scopus citations


Background: Determine the overall, sex-, and racially/ethnically-appropriate population-level cotinine and total nicotine equivalents (TNE-2, the molar sum of the two major nicotine metabolites) cut-points to distinguish tobacco users from nonusers across multiple definitions of use (e.g., exclusive vs. polytobacco, and daily vs. non-daily). Methods: Using Wave 1 (2013-2014) of the U.S. Population Assessment of Tobacco and Health (PATH) Study, we conducted weighted Receiver Operating Characteristic (ROC) analysis to determine the optimal urinary cotinine and TNE-2 cut-points, stratified by sex and race/ethnicity. Results: For past 30-day exclusive cigarette users, the cotinine cut-point that distinguished them from nonusers was 40.5 ng/mL, with considerable variation by sex (male: 22.2 ng/mL; female: 43.1 ng/mL) and between racial/ethnic groups (non-Hispanic other: 5.2 ng/mL; non-Hispanic black: 297.0 ng/mL). A similar, but attenuated, pattern emerged when assessing polytobacco cigarette users (overall cut-point ¼ 39.1 ng/mL, range ¼ 5.5 ng/mL-80.4 ng/mL) and any tobacco users (overall cut-point ¼ 39.1 ng/mL, range ¼ 4.8 ng/mL-40.0 ng/mL). Using TNE-2, which is less impacted by racial differences in nicotine metabolism, produced a comparable pattern of results although reduced the range magnitude. Conclusions: Because of similar frequency of cigarette use among polytobacco users, overall cut-points for exclusive cigarette use were not substantially different from cut-points that included polytobacco cigarette use or any tobacco use. Results revealed important differences in sex and race/ethnicity appropriate cut-points when evaluating tobacco use status and established novel urinary TNE-2 cut-points. Impact: These cut-points may be used for biochemical verification of self-reported tobacco use in epidemiologic studies and clinical trials.

Original languageEnglish (US)
Pages (from-to)1175-1184
Number of pages10
JournalCancer Epidemiology Biomarkers and Prevention
Issue number6
StatePublished - Jun 2021

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© 2021 American Association for Cancer Research.


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