Test Catalog

Test Id : THCX

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Delta-8 and Delta-9-Carboxy-Tetrahydrocannabinol (THC) Confirmation, Chain of Custody, Random, Urine

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Overview

Test Catalog

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

Detection and confirmation of drug use of cannabis/marijuana and will specifically identify and quantify delta-8 THC-COOH and delta-9-THC-COOH

 

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
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.

Testing for adulterants will be performed on all chain of custody urine samples per regulatory requirements.

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

Immunoassay/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

Carboxy-THC Confirmation, CoC, U

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

Cannabinoids (Tetrahydrocannabinol)

J (Jane) (Tetrahydrocannabinol)

Jane (Tetrahydrocannabinol)

Marijuana (Tetrahydrocannabinol)

Mary Jane (Tetrahydrocannabinol)

Tetrahydrocannabinol (THC) Confirmation, Quantitative, Urine

TETRAHYDROCANNABINOL, QN

THC (Tetrahydrocannabinol)

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

Testing for adulterants will be performed on all chain of custody urine samples per regulatory requirements.

Specimen Type
Describes the specimen type validated for testing

Urine

Ordering Guidance

This test is for situations that require the chain-of-custody process. For testing not requiring chain of custody, order THCU / Carboxy-Tetrahydrocannabinol (THC) Confirmation, Random, 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: 5 mL

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

0.5 mL

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

Gross hemolysis OK
Gross icterus Reject

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) 14 days
Frozen 14 days
Ambient 72 hours

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

Detection and confirmation of drug use of cannabis/marijuana and will specifically identify and quantify delta-8 THC-COOH and delta-9-THC-COOH

 

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.

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

Testing for adulterants will be performed on all chain of custody urine samples per regulatory requirements.

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

There are over 100 different cannabinoids in cannabis/marijuana. The main psychoactive cannabinoid is delta-9- tetrahydrocannabinol (delta-9-THC), which is the active agent of the popularly abused street drug, cannabis/marijuana. Delta-8 tetrahydrocannabinol (delta-8-THC) is another psychoactive substance found in the Cannabis sativa plant, of which cannabis/marijuana and hemp are 2 varieties. Delta-8 THC is one of over 100 cannabinoids produced naturally by the cannabis plant but is not typically found in significant amounts in the plant itself. As a result, concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol.

 

Following consumption of cannabis/marijuana, delta-9-THC metabolizes to a variety of inactive products, one of them being the carboxy metabolite (delta-9-THC-COOH). In almost all medico-legal cases or when the patient adamantly denies cannabis/marijuana use and the immunoassay test is positive, confirmation of the result by a definitive test is required. This test is a definitive, confirmatory test using liquid chromatography tandem mass spectrometry to identify and quantify delta-8-THC-COOH and delta-9-THC-COOH.

 

Chain of custody is a record of the disposition of a specimen to document the personnel 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.

Not Detected

Positives are reported with a quantitative-liquid chromatography tandem mass spectrometry LC-MS/MS result.

 

Cutoff concentrations:

IMMUNOASSAY SCREEN

<50 ng/mL

 

DELTA-8 CARBOXY-TETRAHYDROCANNABINOL (THC) by LC-MS/MS: < 5.0 ng/mL

DELTA-9 CARBOXY-TETRAHYDROCANNABINOL (THC) by LC-MS/MS: < 5.0 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

The presence of delta-8 and/or delta-9 carboxy tetrahydrocannabinol (THC-COOH) in urine is a strong indicator that the patient has used cannabis/marijuana.

 

THC-COOH has a long half-life and can be detected in urine for more than 7 days after a single use.

 

Chronic use causes accumulation of THC and THC-COOH in adipose tissue, such that it is excreted into the urine for as long as 30 to 60 days from the time chronic use is halted.

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

No significant cautionary statements

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

1. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 12th ed. Biomedical Publications; 2020

2. 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 test includes immunoassay and confirmation with quantification by liquid chromatography tandem mass spectrometry (LC-MS/MS).

 

The THC immunoassay is based on the kinetic interaction of microparticles in a solutio 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: THC2. Roche Diagnostics; 03/2022)

 

Carboxy tetrahydrocannabinol (THC-COOH) is extracted from urine by making the urine alkaline to hydrolyze THC-COOH glucuronide. The hydrolyzed samples are diluted for analysis by LC-MS/MS) using selected ion monitoring.(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 through 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

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.

80349

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
THCX Carboxy-THC Confirmation, CoC, U 20521-1
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.
2449 Carboxy-THC Immunoassay Screen 19415-9
36238 Delta-9 Carboxy-Tetrahydrocannabinol by LC-MS/MS 20521-1
36239 Carboxy-THC Interpretation 69050-3
36240 Chain of Custody 77202-0
618771 Delta-8 Carboxy-Tetrahydrocannabinol by LC-MS/MS 20521-1

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

Test Update Resources

Change Type Effective Date
Test Changes - Method 2022-12-13