Order Code MTDNX Methadone Confirmation, Chain of Custody, Random, Urine

Useful For

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 always under the control of personnel involved with testing the specimen; this control implies that the opportunity for specimen tampering would be limited.

Additional 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

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

Reporting Name

Methadone Confirmation, CoC, U

Specimen Type

Urine

Specimen Required

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.

Specimen Minimum Volume

2.5 mL

Specimen Stability Information

Specimen Type	Temperature	Time
Urine	Refrigerated (preferred)	28 days
	Frozen	28 days
	Ambient	14 days

Reject Due To

Gross hemolysis	OK
Gross icterus	OK

Method Description

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)

Day(s) Performed

Tuesday, Thursday

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

80358

G0480 (if appropriate)

Method Name

Immunoassay/Gas Chromatography Mass Spectrometry (GC-MS)

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.

Reference Values

Negative

Positives are reported with a quantitative gas chromatography mass spectrometry result.

IMMUNOASSAY SCREEN

<300 ng/mL

Cutoff concentrations:

METHADONE BY GC-MS

<100 ng/mL

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