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Test Code ETGX Ethyl Glucuronide Confirmation, Chain of Custody, Random, Urine


Specimen Required


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.


Useful For

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

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.

Method Name

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Reporting Name

Ethyl Glucuronide Conf, CoC, U

Specimen Type

Urine

Specimen Minimum Volume

2.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Urine Refrigerated (preferred) 28 days
  Frozen  28 days
  Ambient  72 hours

Reject Due To

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

Clinical Information

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

Negative

Cutoff concentrations: 500 ng/mL

Interpretation

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

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.

Method Description

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)

Day(s) Performed

Monday, Wednesday, Friday

Report Available

3 to 5 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

80307

80321

G0480 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ETGX Ethyl Glucuronide Conf, CoC, U 93705-2

 

Result ID Test Result Name Result LOINC Value
36853 ETG Immunoassay Screen 93706-0
63418 Ethyl Glucuronide 58378-1
36850 Ethyl Sulfate 58425-0
36852 Chain of Custody 77202-0
36851 Ethyl Gluc/Sulfate Interpretation 59462-2