OVERVIEW

Purpose: Detection and quantification of methadone. Preferred test to follow up presumptive results methadone urine screening.

CLINICAL INFORMATION

Methadone, a synthetic opioid with no structural relation to natural opiates, effectively binds to opioid receptors. In medical practice, methadone serves to alleviate pain, address opioid withdrawal syndrome and aid in treating heroin addiction by facilitating patients' transition away from illicit drug use.

Metabolism of methadone to inactive forms is the main form of elimination. Methadone is metabolized to a variety of metabolites with the primary metabolite being 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP). Individuals receiving methadone for therapeutic purposes excrete both the original methadone compound and its metabolite, EDDP, through urine. In clinical contexts, it is crucial to measure levels of both methadone and EDDP.

Certain patients undergoing methadone treatment have attempted to manipulate compliance testing by adding a portion of the provided methadone to their urine samples, a practice commonly referred to as "spiking." In such instances, the sample contains significant methadone quantities and minimal to no EDDP content. The absence of EDDP alongside the presence of methadone in urine strongly indicates adulteration of the urine specimen by direct addition of methadone to the specimen.

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
Methadone 50 ng/mL
EDDP 50 ng/mL
CPT code(s): 80358
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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