【INTENDED USE】

The Ethyl Glucuronide (ETG) Rapid Test (Urine) is a rapid chromatographic immunoassay for the detection of Ethyl Glucuronide in human urine. The Ethyl Glucuronide detected by the test includes, but are not limited to, the metabolites of Ethanol.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

【SUMMARY】

Ethyl Glucuronide (ETG) is a metabolite of ethyl alcohol which is formed in the body byglucuronidation following exposure to ethanol,such as by drinking alcoholic beverages.It is used as a biomarker to test for ethanol use and to monitor alcohol abstinence in situationswhere drinking is prohibited,such as in the military, in professional monitoring programs(health professionals,attorneys,airline pilots in recovery from addictions), in schools, inliver transplant clinics,or in recovering alcoholic patients.ETG can be measured in urine by Traditional laboratory methods (GC/MS or LC/MS) upto approximately 80 hours after ethanol is ingested (greatly dependent on the amount of alcoholic and non-alcoholic drinks). ETG is a more accurate indicator of therecent exposure to alcohol than measuring for the presence of ethanol itself.

The Ethyl Glucuronide Rapid Test (Urine) is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of ethyl glucuronide in human urine. The Ethyl Glucuronide Rapid Test Strip (Urine) yields a positive result when the Ethyl Glucuronide in urine exceeds 500 ng/mL.

【DIRECTIONS FOR USE】

Allow the test, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.

1.Bring the pouch to room temperature before opening it. Remove the test Device from the sealed pouch and use it within one hour.

2.Place the test Device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 120ul) to the specimen well (S) of the test Device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below.

3.Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10 minutes.

Directions for Test Strip

4. Bring the pouch to room temperature before opening it. Remove the test strip from the sealed pouch and use it as soon as possible.

5. With arrows pointing toward the urine specimen, immerse the test strip vertically in the urine specimen for at least 10 to 15 seconds. Immerse the strip to at least the level of the wavy lines, but do not pass the maximum line (MAX) on the test strip. [See image (2).]

6. Place the test strip on a non-absorbent flat surface.

7. Start the timer and wait for the colored line(s) to appear.

8. The result should be read at 5 minutes. Results may be stable up to 1 hour after test initiation.

Directions for Test Card

1. Bring the pouch to room temperature before opening it. Remove the test card from the sealed pouch and use it as soon as possible.

2.Remove the cap.

3.With the arrow pointing toward the urine specimen, immerse the test card vertically in the urine specimen for at least 10 to 15 seconds. Immerse the strip to at least the level of the wavy lines, but not above the arrow on the test card. [See image (1).]

4.Replace the cap and place the test card on a non-absorbent flat surface.

5.Start the timer and wait for the colored line(s) to appear.

6.The result should be read at 5 minutes. Results may be stable up to 1 hour after test initiation.