Test Catalog

Test Id : MTDNX

Methadone Confirmation, Chain of Custody, Random, Urine

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

Monitoring for compliance of methadone treatment for analgesia or drug rehabilitation

 

Assessing compliance with rehabilitation programs

 

Chain of custody is required whenever the results of testing could be used in a court of law. Its purpose is to protect the rights of the individual contributing the specimen by demonstrating that it was under the control of personnel involved with testing the specimen at all times; this control implies that the opportunity for specimen tampering would be limited

Additional Tests
Lists tests that are always performed, at an additional charge, with the initial tests.

Test Id Reporting Name Available Separately Always Performed
COCH Chain of Custody Processing No Yes
ADLTX Adulterants Survey, CoC, U Yes Yes

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Adulterants testing will be performed on all chain of custody urine samples as per regulatory requirements.

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

Immunoassay/Gas Chromatography-Mass Spectrometry (GC-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

Methadone Confirmation, CoC, U

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

2-Ethylidene-1,5-Dimethyl-3,3-Diphenylpyrrolidine

Dolophine (Methadone)

EDDP

Methadone (Dolophine)

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Adulterants testing will be performed on all chain of custody urine samples as per regulatory requirements.

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: Chain of Custody Kit (T282)

Container/Tube: Chain-of-custody kit containing the specimen containers, seals, and documentation required.

Specimen Volume: 10 mL

Collection Instructions: Collect urine specimen in the container provided, seal, and submit with the associated documentation to satisfy the legal requirements for chain-of-custody testing.

Additional Information: Submitting less than 10 mL will compromise our ability to perform all necessary testing.

Forms

1. Chain of Custody Request is included in the Chain-of-Custody Kit (T282).

2. 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

2.5 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 28 days
Ambient 14 days

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

Monitoring for compliance of methadone treatment for analgesia or drug rehabilitation

 

Assessing compliance with rehabilitation programs

 

Chain of custody is required whenever the results of testing could be used in a court of law. Its purpose is to protect the rights of the individual contributing the specimen by demonstrating that it was under the control of personnel involved with testing the specimen at all times; this control implies that the opportunity for specimen tampering would be limited

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Adulterants testing will be performed on all chain of custody urine samples as per regulatory requirements.

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

Methadone (dolophine) is a synthetic opioid, a compound that is structurally unrelated to natural opiates but is capable of binding to opioid receptors. These receptor interactions create many of the same effects seen with natural opiates, including analgesia and sedation. However, methadone does not produce feelings of euphoria and has substantially fewer withdrawal symptoms than opiates such as heroin.(1) Methadone is used clinically to relieve pain, treat opioid abstinence syndrome, and treat heroin addiction in an attempt to wean patients from illicit drug use.

 

Metabolism of methadone to inactive forms is the main form of elimination. Oral delivery of methadone makes it subject to first-pass metabolism by the liver and creates interindividual variability in its bioavailability, which ranges from 80% to 95%. The most important enzymes in methadone metabolism are cytochrome P450 (CYP) 3A4 and CYP2B6.(1-4) CYP2D6 appears to have a minor role, and CYP1A2 may possibly be involved.(1-5) Methadone is metabolized to a variety of metabolites, the primary metabolite is 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP).(1-4) The efficiency of this process is prone to wide inter- and intraindividual variability due to inherent differences in enzymatic activity as well as enzyme induction or inhibition by numerous drugs. Excretion of methadone and its metabolites (including EDDP) occurs primarily through the kidneys.(1,4)

 

Patients who are taking methadone for therapeutic purposes excrete both parent methadone and EDDP in their urine. Clinically, it is important to measure levels of both methadone and EDDP. Methadone levels in urine vary widely depending on factors such as dose, metabolism, and urine pH.(5) EDDP levels, in contrast, are relatively unaffected by the influence of pH and are, therefore, preferable for assessing compliance with therapy.(5)

 

Some patients undergoing treatment with methadone have attempted to pass compliance testing by adding a portion of the supplied methadone to the urine.(6) This is commonly referred to as "spiking.'' In these situations, the specimen will contain large amounts of methadone and no or very small amounts of EDDP.(6) The absence of EDDP in the presence of methadone in urine strongly suggests adulteration of the urine specimen by direct addition of methadone to the specimen.

 

Chain of custody is a record of the disposition of a specimen to document each individual who collected, handled, and performed the analysis. When a specimen is submitted in this manner, analysis will be performed in such a way that it will withstand regular court scrutiny.

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.

Negative

 

Cutoff concentrations:

METHADONE BY GC-MS

<100 ng/mL

2-ETHYLIDENE-1,5-DIMETHYL-3,3-DIPHENYLPYRROLIDINE GC-MS

<100 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

The absolute concentration of methadone and its metabolites found in patient urine specimen can be highly variable and do not correlate with dose. However, the medical literature and our experience show that patients who are known to be compliant with their methadone therapy have ratios of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP):methadone of greater than 0.60.(7)

 

An EDDP: methadone ratio less than 0.090 strongly suggests manipulation of the urine specimen by direct addition of methadone to the specimen.(6)

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

Urine pH has a considerable effect on the ability to detect methadone, thus 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine is preferable for urine measurements.

 

Urine concentrations of methadone show very poor correlation to serum levels or the amount of drug administered.

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

1. Gutstein HB, Akil H: Opioid analgesics. In: Hardman JG, Limbird LE, eds. Goodman and Gilman's: The Pharmacological Basis of Therapeutics. 10th ed. McGraw-Hill; 2001:569-619

2. Eap CB, Buclin T, Baumann P: Interindividual variability of the clinical pharmacokinetics of methadone: implications for the treatment of opioid dependence. Clin Pharmacokinet. 2002;41(14):1153-1193

3. Ferrari A, Coccia CP, Bertolini A, Sternieri E: Methadone-metabolism, pharmacokinetics and interactions. Pharmacol Res. 2004 Dec;50(6):551-559

4. Baselt RC: Disposition of Toxic Drugs and Chemicals in Man. 7th ed. Chemical Toxicology Institute; 2005

5. Levine B: Principles of Forensic Toxicology. 2nd ed. AACC Press; 2003:385

6. Galloway FR, Bellet NF: Methadone conversion to EDDP during GC-MS analysis of urine samples. J Anal Toxicol. Nov-Dec 1999;23(7):615-619

7. George S, Braithwaite RA: A pilot study to determine the usefulness of the urinary excretion of methadone and its primary metabolite (EDDP) as potential markers of compliance in methadone detoxification programs. J Anal Toxicol. 1999;23:81-85

8. Langman LJ, Bechtel LK, Meier BM, Holstege C: Clinical Toxicology. In: Rifai N, Horvath AR, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:832-887

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

This assay is based on the kinetic interaction of microparticles in a solution as measured by changes in light transmission. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When a urine sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.(Package insert: EDDP Specific Urine Enzyme Immunoassay, Immunalysis Corp; 09/2018)

 

Confirmation with quantification is performed by gas chromatography-mass spectrometry (GC-MS).(Unpublished Mayo method)

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, Wednesday, Friday

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.

3 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

14 days

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.

80358

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
MTDNX Methadone Confirmation, CoC, U In Process
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.
21105 Methadone Immunoassay Screen 70149-0
36208 EDDP-by GC-MS 58429-2
36209 Methadone-by GC-MS 16199-2
36210 Methadone Interpretation 69050-3
36211 Chain of Custody 77202-0

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