title: Evaluation of urinary cotinine immunoassay test strips used to assess smoking status.
abstract: BACKGROUND
  Validation of smoking status is a vital component for assessing self-reported smoking status. This study examined commercially available urinary cotinine immunoassay strips to evaluate their effectiveness and their reliability in validating self-reported tobacco usage.
  
  
  METHODS
  This study compared cotinine values from urinary test strips and liquid chromatography-mass spectrometry (LC-MS/MS) obtained from 100 self-reported nonsmokers and 201 self-reported smokers.
  
  
  RESULTS
  The analyzed test strips, with 100 ng/ml as the cutoff value, have 91% (84%-96% CI) specificity and 92% (86%-95% CI) sensitivity. The test strips successfully identified nonsmokers from smokers with excellent reproducibility. However, self-reported smokers have significantly different (p < .001) test strip results when compared with the expected LC-MS/MS values.
  
  
  CONCLUSIONS
  Overall, the test strip demonstrated that it discriminates nonsmokers from smokers and is an adept alternative to chromatographic methods.
authors.affiliation: Office of Research, Evaluation and Surveillance, Controlled Substance and Tobacco Directorate, Healthy Environments and Consumer Safety Branch, Health Canada, Ottawa, Ontario, Canada. eva.yeh@hc-sc.gc.ca
authors.forename: Eva
authors.initials: E
authors.lastname: Yeh
authors.forename: Geneviève
authors.initials: G
authors.lastname: Levasseur
authors.forename: Murray J
authors.initials: MJ
authors.lastname: Kaiserman
mesh_terms: D000328:Adult; D000368:Aged; D002853:Chromatography, Liquid; D003367:Cotinine / Q000652:urine*; D005260:Female; D006801:Humans; D007118:Immunoassay; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000378:metabolism; D011934:Reagent Strips; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012907:Smoking; D053719:Tandem Mass Spectrometry; D014029:Tobacco Use Disorder / Q000175:diagnosis*; D055815:Young Adult
chemical_list: D011934:Reagent Strips; D009538:Nicotine; D003367:Cotinine