OVERVIEW

Purpose: Detection and quantification of cotinine in urine.

CLINICAL INFORMATION

Nicotine undergoes rapid hepatic metabolism, converting into cotinine with an elimination half-life of 2 hours. Cotinine, in turn, demonstrates an apparent elimination half-life of 15 hours. For individuals using tobacco products, urinary excretion of nicotine generally falls within the range of 1,000 to 5,000 ng/mL. Meanwhile, cotinine accumulation in urine is linked to dosage and hepatic metabolism, which carries a genetic basis. Most tobacco users excrete cotinine levels spanning 1,000 to 8,000 ng/mL. Within these concentration ranges, indications of tobacco use, or high-dose nicotine patch therapy. Upon a two-week cessation period, heavy tobacco users exhibit urine nicotine levels below 30 ng/mL and cotinine levels below 50 ng/mL. Passive exposure to tobacco smoke, even in non-tobacco users, can lead to the buildup of nicotine metabolites in urine, resulting in cotinine levels reaching up to 20 ng/mL.

Quantifying urine nicotine and metabolites while a patient is actively consuming tobacco products aids in defining the concentrations achieved through self-administration. This insight guides the tailoring of nicotine replacement doses to match the patient's accustomed levels. This strategy is particularly valuable in the early stages of treatment, mitigating the intense cravings often experienced during withdrawal. Verification of adequate nicotine replacement can be achieved by measuring urine nicotine and metabolite concentrations at a steady state (typically 2-3 days after commencing replacement therapy). Once a patient is stabilized and responding positively to therapy, the replacement dose can be gradually tapered to facilitate complete withdrawal.

SPECIMEN COLLECTION

Specimen Type: Random Urine
Preferred Collection Container: Non-sterile specimen container
Specimen Required: 3 mL urine; minimum 1 mL

TEST DETAILS

Methodology: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
Compliance Category: Laboratory Developed Test (LDT)
This test was developed and assessed by DMD in compliance with CLIA requirements for its analytical performance characteristics and clinical application. This test has not been cleared or approved by the US Food and Drug Administration.
Reference Interval: Negative
Drug/Metabolite Tested:
Drug/Metabolite Cutoff concentration 500 ng/mL
Cotinine 50 ng/mL
CPT code(s): 80323
Turnaround Time: 90% < 48 hours, 50% < 24 hours

SPECIMEN PROCESSING

Transport Temperature: Refrigerated (preferred) or room temperature overnight shipping.
Specimen Stability: 3 days at room temperature and 14 days at refrigerated and frozen temperatures (to be further confirmed with our validation).
Rejection Criteria: Stability limits exceeded.

Director: Cheryl Hanau, MD; Donald Hall Jr., PhD; Garth Ehrlich, PhD; Yinghua Qiu, PhD, DABCC

Review Date: 08/28/2023

Note: The billing party has sole responsibility for CPT coding. Any questions regarding coding should be directed to the payer being billed. The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.

The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.

 
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