Test Catalog

Test Id : NICOU

Nicotine and Metabolites, Random, Urine

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring tobacco use

 

Monitoring patients on nicotine-replacement therapy for concurrent use of tobacco products

Method Name
A short description of the method used to perform the test

Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Nicotine and Metabolites, U

Aliases
Lists additional common names for a test, as an aid in searching

Anabasine

Cotinine

Nornicotine

Tobacco Alkaloids

Specimen Type
Describes the specimen type validated for testing

Urine

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt 5 mL Aliquot Tube (T914)

Container/Tube: Plastic, 5 mL, aliquot tube

Specimen Volume: 3 mL

Collection Instructions:

1. Collect a random urine specimen.

2. No preservative.

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

2 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Urine Refrigerated (preferred) 28 days
Frozen 365 days
Ambient 28 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring tobacco use

 

Monitoring patients on nicotine-replacement therapy for concurrent use of tobacco products

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Tobacco use is the leading cause of death in the United States. Nicotine, coadministered in tobacco products such as cigarettes, pipe, cigar, or chew, is an addictive substance that causes individuals to continue use of tobacco despite concerted efforts to quit. Nicotine stimulates dopamine release and increases dopamine concentration in the nucleus accumbens, a mechanism that is thought to be the basis for addiction for drugs of abuse.

 

Nicotine is rapidly metabolized in the liver to cotinine, exhibiting an elimination half-life of 2 hours. Cotinine exhibits an apparent elimination half-life of 15 hours. Patients using tobacco products excrete nicotine in urine in the concentration range of 1000 to 5000 ng/mL. Cotinine accumulates in urine in proportion to dose and hepatic metabolism (which is genetically determined); most tobacco users excrete cotinine in the range of 1000 to 8000 ng/mL. Urine concentrations of nicotine and metabolites in these ranges indicate the subject is using tobacco or is receiving high-dose nicotine patch therapy.

 

In addition to nicotine and metabolites, tobacco products also contain other alkaloids that can serve as unique markers of tobacco use. Two such markers are anabasine and nornicotine. Anabasine is present in tobacco products but not in nicotine replacement therapies. Nornicotine is present as an alkaloid in tobacco products and as a metabolite of nicotine. The presence of anabasine (>10 ng/mL) or nornicotine (>30 ng/mL) in urine indicates current tobacco use, irrespective of whether the subject is on nicotine replacement therapy. The presence of nornicotine without anabasine is consistent with use of nicotine replacement products. Heavy tobacco users who abstain from tobacco for 2 weeks exhibit urine nicotine values below 30 ng/mL, cotinine values below 50 ng/mL, anabasine levels below 2 ng/mL, and nornicotine levels below 2 ng/mL.

 

Passive exposure to tobacco smoke can cause accumulation of nicotine metabolites in nontobacco users. Urine cotinine has been observed to accumulate up to 20 ng/mL from passive exposure. Neither anabasine nor nornicotine accumulates from passive exposure.

 

Tobacco users engaged in programs to abstain from tobacco require support in the form of counseling, pharmacotherapy, and continuous encouragement. Occasionally, counselors may elect to monitor abstinence by biochemical measurement of nicotine and metabolites in a random urine specimen to verify abstinence. If results of biologic testing indicate the patient is actively using a tobacco product during therapy, additional counseling or intervention may be appropriate.

 

Quantification of urine nicotine and metabolites while a patient is actively using a tobacco product is useful to define the concentrations that a patient achieves through self-administration of tobacco. Nicotine replacement dose can then be tailored to achieve the same concentrations early in treatment to assure adequate nicotine replacement so the patient may avoid the strong craving they may experience early in the withdrawal phase. This can be confirmed by measurement of urine nicotine and metabolite concentrations at steady state (2-3 days after replacement therapy is started). Once the patient is stabilized on the dose necessary to achieve complete replacement and responding well to therapy, the replacement dose can be slowly tapered to achieve complete withdrawal.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Non-tobacco user with no passive exposure:

NICOTINE

<5.0 ng/mL

 

COTININE

<5.0 ng/mL

 

ANABASINE

<2.0 ng/mL

 

NORNICOTINE

<2.0 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

Urine nicotine in the range of 1000 to 5000 ng/mL with cotinine in the range of 1000 to 8000 ng/mL indicates the subject is either actively using a tobacco product or on high-dose nicotine patch therapy.

 

The presence of anabasine and nornicotine indicates a subject on patch therapy who is actively using a tobacco product.

 

Typical findings are as follows:

 

While using a tobacco product:

-Peak nicotine concentration: 1000 to 5000 ng/mL

-Peak cotinine concentration: 1000 to 8000 ng/mL

-Anabasine concentration: 10 to 500 ng/mL

-Nornicotine concentration: 30 to 900 ng/mL

 

Tobacco user after 2 weeks complete abstinence:

-Nicotine concentration: <30 ng/mL

-Cotinine concentration: <50 ng/mL

-Anabasine concentration: <2.0 ng/mL

-Nornicotine concentration: <2.0 ng/mL

 

Nontobacco user with passive exposure:

-Nicotine concentration: <20 ng/mL

-Cotinine concentration: <20 ng/mL

-Anabasine concentration: <2.0 ng/mL

-Nornicotine concentration: <2.0 ng/mL

 

Nontobacco user with no passive exposure:

-Nicotine concentration: <5.0 ng/mL

-Cotinine concentration: <5.0 ng/mL

-Anabasine concentration: <2.0 ng/mL

-Nornicotine concentration: <2.0 ng/mL

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Knowledge of time elapsed between last dose and specimen collection is important for interpretation of test results.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Dale LC, Hurt RD, Hays JT: Drug therapy to aid in smoking cessation. Tips on maximizing patients' chances for success. Postgrad Med. 1998 Dec;104(6):75-78, 83-84

2. Rudasingwa G, Kim Y, Lee C, Lee J, Kim S, Kim S. Comparison of nicotine dependence and biomarker levels among traditional cigarette, heat-not-burn cigarette, and liquid e-cigarette users: Results from the Think Study. Int J Environ Res Public Health. 2021 Apr 29;18(9):4777. doi: 10.3390/ijerph18094777

3. Sharma P, Sane N, Anand SD, Marimutthu P, Benegal V. Assessment of cotinine in urine and saliva of smokers, passive smokers, and nonsmokers: Method validation using liquid chromatography and mass spectrometry. Indian J Psychiatry. 2019 May-Jun;61(3):270-276. doi: 10.4103/psychiatry.IndianJPsychiatry_61_18

Method Description
Describes how the test is performed and provides a method-specific reference

Nicotine and metabolites are extracted from urine by solid-phase extraction techniques. The extract eluate is quantified by high-performance liquid chromatography-tandem mass spectrometry.(Moyer TP, Charlson JR, Enger RJ, et al: Simultaneous analysis of nicotine, nicotine metabolites, and tobacco alkaloids in serum or urine by tandem mass spectrometry, with clinically relevant metabolic profiles. Clin Chem 2002 Sep;48(9):1460-1471; Oh J, Park MS, Chun MR, et al: A simple and high-throughput LC-MS/MS method for simultaneous measurement of nicotine, cotinine, 3-OH cotinine, nornicotine, and anabasine in urine and its application in the general Korean population. J Anal Toxicol. 2020 Nov 24:bkaa177. doi: 10.1093/jat/bkaa177. Epub ahead of print)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 5 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80323

G0480 (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
NICOU Nicotine and Metabolites, U 43125-4
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
82510 Nicotine 3854-7
21321 Cotinine 10366-3
21324 Nornicotine 33917-6
21323 Anabasine 33915-0

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports