Test Id : THCX
Delta-8 and Delta-9-Carboxy-Tetrahydrocannabinol (THC) Confirmation, Chain of Custody, Random, Urine
    
        Useful For
            
                
                
                    
                    Suggests clinical disorders or settings where the test may be helpful
                
            
    
    Detection and confirmation of drug use of cannabis/marijuana and to specifically identify and quantify delta-8 carboxy tetrahydrocannabinol (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.
                
            
    
    
    
        Reporting Name
            
                
                
                    
                    Lists a shorter or abbreviated version of the Published Name for a test
                
            
    
    
    
        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 / Delta-8 and Delta-9-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 required documentation.
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. The minimum volume is sufficient for one attempt at testing.
                
            
    
    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 | |
| Ambient | 72 hours | ||
| Frozen | 14 days | 
    
        Useful For
            
                
                
                    
                    Suggests clinical disorders or settings where the test may be helpful
                
            
    
    Detection and confirmation of drug use of cannabis/marijuana and to specifically identify and quantify delta-8 carboxy tetrahydrocannabinol (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
Positive results are reported with a quantitative result.
 
Cutoff concentrations:
Immunoassay Screen: 50 ng/mL
 
Liquid chromatography tandem mass spectrometry:
Delta8- tetrahydrocannabinol (THC): 5.0 ng/mL
Delta-9-THC: 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, Holstege CP. Clinical toxicology. In: Rifai N, Chiu RWK, Young I, Burnham CAD, Wittwer CT, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:chap 43
    
        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 tetrahydrocannabinol (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
                
            
    
    
    
        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 Sunday
    
        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.
                
            
    
    
    
        Specimen Retention Time
            
                
                
                    
                    Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
                
            
    
    
    
        Performing Laboratory Location
            
                
                
                    
                    Indicates the location of the laboratory that performs the test
                
            
    
    
    
        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.
                
            
    
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 - Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
 - Prospective clients should contact their account representative. 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. It 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.
                
            
    
    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 | 102114-6 | 
| 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 |