Protocol - Biomarker of exposure to nicotine-containing products - Urine
Description
A biospecimen is collected from the respondent to measure cotinine, a marker of either smoking or of environmental tobacco smoke exposure. One of the most common methods is via a urine sample obtained from the respondent. Cotinine in urine is measured by gas chromatography mass spectrometry (GC-MS).
Specific Instructions
Caffeine may interfere with the accuracy of the results. During the gas chromatography analysis, this interference can be minimized by ramping up the temperature and eluting the caffeine later than the cotinine.
Protocol
The respondent is asked to urinate in a sterile 90-mL urine specimen container. Children above the age of 10 and adults can self-collect the urine. The specimen should be refrigerated immediately after collection. Aliquot 3mLs into a 4 mL cryovial. Freeze the cryovial at -20°C until analysis. If the samples need to be stored greater than 1 year freeze at -80°C.
Gas chromatography mass spectrometry (GC-MS) is the preferred method to accurately measure cotinine in urine samples. (See source references for details.) The limit of detection is 0.20 ng/mL. A result of 100 ng/mL urinary cotinine or more is indicative of an active smoker.
Availability
Personnel and Training Required
Urine samples can be self-collected by children aged 10 or older with adequate instructions. A laboratory technician trained to process and analyze biological specimens is necessary to analyze urine samples.
Equipment Needs
Standard urine collection supplies that have been sterilized. Laboratory supplies and instruments are needed to measure cotinine in biological fluids. Biological samples may be shipped using appropriate shipping procedures to laboratories that specialize in these types of analysis.
Requirements
| Requirement Category | Required |
|---|---|
| Major equipment | No |
| Specialized training | Yes |
| Specialized requirements for biospecimen collection | No |
| Average time of greater than 15 minutes in an unaffected individual | No |
Mode of Administration
Bioassay
Lifestage
Child, Adolescent, Adult, Senior, Pregnancy
Participants
Ages 3 and up
Selection Rationale
Urine is easily collected and with the proper laboratory equipment, cotinine can be measured accurately from a sterile urine sample. Urinary cotinine is a frequently measured biomarker and produces more quantifiable results than other metabolites.
There are other assays (e.g., radioimmunoassay and enzyme-linked immunosorbent assays) used to measure cotinine but gas chromatography mass spectrometry (GC-MS) is preferred.
Language
Chinese, English
Standards
| Standard | Name | ID | Source |
|---|---|---|---|
| Logical Observation Identifiers Names and Codes (LOINC) | Resp urine assay smoke exp proto | 62641-6 | LOINC |
| caDSR Form | PhenX PX091701 - Urine Assay For Tobacco Smoke Exposure | 5970459 | caDSR Form |
Derived Variables
None
Process and Review
The Expert Review Panel #6 (ERP 6) reviewed the measures in the Respiratory domain.
Guidance from ERP 6 includes:
- Revised descriptions of the measure
- Changed the name of the measure from "Urine Assay for Tobacco Smoke Exposure" to "Biomarker of Exposure to Nicotine-containing Products"
Previous version can be found in the Toolkit archive (link)
Protocol Name from Source
Man, C. N., et al, Simple, rapid and sensitive assay method for simultaneous quantification of urinary nicotine and cotinine using gas chromatography-mass spectrometry, J CHROMATOGR, 2006
Source
Man, C. N., L.-H. Gam, Ismail, S., Lajis, R., Awang, R. 2006. Simple, rapid and sensitive assay method for simultaneous quantification of urinary nicotine and cotinine using gas chromatography-mass spectrometry. J of Chromatography B 844(2): 322-327.
General References
Avila-Tang E, Al-Delaimy WK, Ashley DL, Benowitz N, Bernert JT, Kim S, Samet JM, Hecht SS. (2013). Assessing secondhand smoke using biological markers. Tob Control, 22(3): 164-871.
Benowitz, N.L. (1999). Biomarkers of Environmental Tobacco Smoke Exposure. Environ Health Perspect. 107(Suppl 2):3 49-355.
Benowitz, N. L. (1996). Cotinine as a biomarker of environmental tobacco smoke exposure. Epidemiol Rev, 18(2), 188-204.
Dhar, P. (2004). Measuring tobacco smoke exposure: quantifying nicotine/cotinine concentration in biological samples by colorimetry, chromatography and immunoassay methods. J Pharm Biomed Anal, 35(2004), 155-168.
Kuo, H.W., Yang, J.S., Chiu, M.C. (2002). Determination of urinary and salivary cotinine using gas and liquid chromatography and enzyme-linked immunosorbent assay. J Chromatogr B Analyt Technol Biomed Life Sci. 768(2):297-303.
Protocol ID
91701
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX091701_Cotinine_Concentration | ||||
| PX091701010000 | Concentration of urinary cotinine in ng/mL. | Variable Mapping | ||
Measure Name
Biomarker of exposure to nicotine-containing products
Release Date
May 12, 2010
Definition
Cotinine is a major metabolite of nicotine and is an indicator of exposure to nicotine from tobacco or other nicotine containing products.
Purpose
To assess smoking and environmental tobacco smoke (ETS) exposure by measuring cotinine, a metabolite of nicotine. To screen for tobacco use and quantity and to estimate exposure to secondhand smoke (SHS) and all tobacco exposure. Also used as an outcome measure in smoking cessation trials to determine if an individual has quit smoking.
Keywords
biomarker of exposure to nicotine-containing products - urine, cotinine, Centers for Disease Control and Prevention, CDC, National Health and Nutrition Examination Survey, NHANES, Respiratory
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 91701 | Biomarker of exposure to nicotine-containing products - Urine |
| 91702 | Biomarker of exposure to nicotine-containing products - Saliva |
| 91703 | Biomarker of exposure to nicotine-containing products - Serum |
Publications
There are no publications listed for this protocol.