Test Catalog

Test Id : ETGX

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Ethyl Glucuronide 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

Monitoring abstinence in clinical and justice system settings using ethyl glucuronide and ethyl sulfate as direct biomarkers or metabolites of ethanol

 

This chain-of-custody test is intended to be used in a setting where the test results can be used definitively to make a diagnosis.

 

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.

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

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

Ethyl Glucuronide Conf, CoC, U

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

Alcohol biomarkers

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 is required.

Specimen Volume: 5 mL

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

Additional Information: Submitting less than 5 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. The minimum volume is sufficient for one attempt at testing.

2.5 mL

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

  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

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 72 hours

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

Monitoring abstinence in clinical and justice system settings using ethyl glucuronide and ethyl sulfate as direct biomarkers or metabolites of ethanol

 

This chain-of-custody test is intended to be used in a setting where the test results can be used definitively to make a diagnosis.

 

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.

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

Ethyl glucuronide and ethyl sulfate are minor metabolites of ethanol that are detectable in body fluids following alcohol consumption and, less commonly, following extraneous exposure. Ethyl glucuronide (EtG) and ethyl sulfate (EtS) are direct biomarkers or metabolites of ethanol. EtG and EtS can be detected up to 5 days in urine using a cutoff of 500 ng/mL.(1)

 

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: 500 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

A positive interpretation will be given if either the ethyl glucuronide result is greater than or equal to 250 ng/mL or the ethyl sulfate is greater than or equal to 100 ng/mL.

 

A "high" positive (ie, >1000 ng/mL) may indicate:

-Heavy drinking on the same day or previously (ie, previous day or 2)

-Light drinking the same day

 

A "low" positive (ie, 500-1000 ng/mL) may indicate:

-Previous heavy drinking (ie, previous 1-3 days)

-Recent light drinking (ie, past 24 hours)

-Recent intense "extraneous" exposure (ie, within 24 hours or less)

 

A "very low" positive (ie, 100-500 ng/mL) may indicate:

-Previous heavy drinking (ie, 1-3 days)

-Previous light drinking (ie, 12-36 hours)

-Recent "extraneous" exposure

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

Incidental exposure to alcohol in many daily use products (ie, hand sanitizers, mouthwash) may result in detectable levels of ethyl glucuronide (EtG) and ethyl sulfate (EtS).

 

In addition, upper respiratory infections as well as beta-glucuronidase hydrolysis may lower levels of EtG but do not seem to affect EtS.(2)

 

EtG/EtS results should be interpreted in the context of all available clinical and behavioral information.

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

1. Reisfield GM, Goldberger BA, Crews BO, et al. Ethyl glucuronide, ethyl sulfate, and ethanol in urine after sustained exposure to an ethanol-based hand sanitizer. J Anal Toxicol. 2011;35(2):85-91. doi:10.1093/anatox/35.2.85

2. Substance Abuse and Mental Health Services Administration (SAMSHA) Advisory: The role of biomarkers in the treatment of alcohol use disorders, 2012 Revision. HHS; 2012;11(2):1-7. doi:10.1037/e558582006-001

3. 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

The assay uses an ethyl glucuronide recombinant antibody. It is based on the competition of ethyl glucuronide labeled enzyme glucose-6-phosphate dehydrogenase (G6PD) and the free drug in the urine sample for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine and enzyme activity. The enzyme G6PD activity is determined at 340 nm spectrophotometrically by the conversion of nicotinamide adenine dinucleotide (NAD[+] to NADH.(Package insert: ETG. Immunalysis; 03/2019)

 

The urine sample is diluted with internal standard in 0.1% formic acid for detection by tandem mass spectrometry.(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 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.

80307

80321

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
ETGX Ethyl Glucuronide Conf, CoC, U 93705-2
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.
36850 Ethyl Sulfate 58425-0
36853 ETG Immunoassay Screen 93706-0
63418 Ethyl Glucuronide 58378-1
36852 Chain of Custody 77202-0
36851 Ethyl Gluc/Sulfate Interpretation 59462-2

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