Ethyl Glucuronide Rapid Test

Sample

Urine

Intended Use

The EtG Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative presumptive detection of Ethyl Glucuronide in human urine specimens at the cut-off concentrations listed below:
This assay provides only a preliminary result and is intended for professional use only. Clinical consideration and professional judgment must be applied particularly when evaluating a positive result. In order to obtain a confirmed analytical result a more specific alternate chemical method is needed. Liquid Chromatography/Mass Spectrometry (LC/MS) is the preferred confirmation method.

Storage

1. The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Kits should be kept out of direct sunlight.

Performance Characteristics

A. Accuracy
The accuracy of the EtG Rapid Test Device was evaluated in comparison to a commercially avaialbe EIA Test. Five Hundred (500) clinical samples were tested. All positive samples were confirmed by Liquid Chromatography/Mass Spectrometry.

B. Reproducibility
The reproducibility of the EtG Rapid Test Device (Urine) was verified by blind tests performed at four different locations. Samples with EtG concentrations at 50% of the cut-off were all determined to be negative, while samples with EtG concentrations at 200% of the cut-off were all determined to be positive.
C. Precision
Test precision was determined by blind tests with control solutions. Controls with EtG concentrations at 50% of the cut-off yielded negative results, and controls with EtG concentrations at 150% of the cut-off yielded positive results.
D. Cross-reactivity
The following compounds yielded negative results up to a concentration of 100 μg/mL:

General Description

Ethyl Glucuronide (EtG) is a direct metabolite of ethanol, which is formed by enzymatic conjugation of ethanol with glucuronic acid. Alcohol in urine is normally detected for only a few hours, whereas EtG can be detected up to several days even after complete elimination of alcohol from the body. Therefore, EtG can be a useful diagnostic biomarker for determining recent alcohol use and in monitoring abstinence in alcoholics in alcohol withdrawal treatment programs.
Ethanol can be produced in vitro due to fermentation of urine samples containing sugars (diabetes), bacteria or yeast when samples are exposed to warm temperatures. In such cases, EtG test can be used, as a confirmatory test to determine if the alcohol in the sample is due to consumption of alcohol or it is formed in vitro as a result of fermentation. Currently EtG is monitored by GC/MS and LC/MS/MS.
Ethyl glucuronide (EtG) is a minor non-oxidative metabolite of ethyl alcohol formed by the in vivo conjugation of ethanol with glucuronic acid with UDP glucuronosyl transferase. ETG is a product of metabolic process of Ingested alcohol (ethanol) rapidly metabolized in the body, which is excreted in the blood, hair and urine. By using the ETG Rapid Test Device EtG can be detected in urine, confirming the consumption of alcohol. The EtG metabolite remains in the body longer and therefore has a more useful window of detection of 8 to 80 hours. EtG testing is an excellent option for zero-tolerance alcohol consumption or for rehabilitation programs.