Journal Article

Automated Homogeneous Immunoassay Analysis of Cotinine in Urine

R. Sam Niedbala, Nancy Haley, Stephanie Kardos and Keith Kardos

in Journal of Analytical Toxicology

Volume 26, issue 3, pages 166-170
Published in print April 2002 | ISSN: 0146-4760
Published online April 2002 | e-ISSN: 1945-2403 | DOI: http://dx.doi.org/10.1093/jat/26.3.166
Automated Homogeneous Immunoassay Analysis of Cotinine in Urine

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A study was conducted to evaluate the performance comparison of a homogeneous enzyme immunoassay (EIA) designed to detect cotinine in urine and carbon monoxide (CO) breath measurements to determine smoking status. The clinical comparison was done using urine and breath specimens from 218 volunteers. Urine samples were analyzed by immunoassay and confirmed by gas chromatography-mass spectrometry (GC-MS). Breath carbon monoxide was determined by a commercial analyzer. Using cutoffs of 10 ppm for CO and 500 ng/m/for urinary cotinine, the relative sensitivity/specificity was 93.6%/74.0%. The positive predictive value was 86.8%, and the negative predictive value was 86.5%. However, comparison of the EIA to GC-MS showed a sensitivity/specificity of 96.2%/98.4% and a positive predictive value of 99.3%. The EIA was also evaluated non-clinically for precision, stability, recovery, and interferences. In addition, the non-clinical evaluation demonstrated coefficients of variation from 0.37 to 1.09% across cotinine concentrations ranging from 0 to 5000 ng/mL. The assay was found to be highly specific for cotinine and cross-reacted to a limited degree with 3-hydroxycotinine. Finally, multiple freeze-thaw cycles of urines containing cotinine showed no degradation of the drug in the specimen when tested in the EIA. Thus, the EIA tested is a rapid, lab-based test that can reliably determine cotinine levels and their relation to smoking status.

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Subjects: Medical Toxicology ; Toxicology (Non-medical)

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