Ethyl Glucuronide (ETG) Rapid Test Cassette (Urine),ethyl alcohol, 500ng/mL cut off
A rapid test for the qualitative detection of Ethyl Glucuronide in human urine.
For medical and other professional in vitro diagnostic use only.
| Principle |
Chromatographic Immunoassay |
| Format |
Dipstick, Cassette, Panel, Cup |
| Specimen |
Urine, Hair |
| Certificate |
CE |
| Reading Time |
5 minutes |
| Pack |
10T/40T/50T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
| Sensitivity |
97.60% |
| Specificity |
99.40% |
| Accuracy |
98.80% |
| Cut-Off |
500 ng/mL*, 1000 ng/mL, 0.2 ng/mg |
INTENDED USE
The Ethyl Glucuronide (ETG) Rapid Test Cassette (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 Cassette (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.
PRINCIPLE
The ETG Rapid Test Cassette (Urine) is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary action. Ethyl Glucuronide, if present in the urine specimen below 500ng/mL, will not saturate the binding sites of antibody-coated particles in the test device. The antibody-coated particles will then be captured by immobilized Ethyl Glucuronide conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Ethyl Glucuronide level exceeds 500ng/mL because it will saturate all the binding sites of anti- Ethyl Glucuronide antibodies.
A drug-positive urine specimen will not generate a colored line in the test line region, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
REAGENTS
The test cassette contains mouse monoclonal anti- ethyl glucuronide antibody-coupled particles and ethyl glucuronide -protein conjugate. A goat antibody is employed in the control line system.
PRECAUTIONS
- For medical and other professional in vitro diagnostic use only. Do not use after the expiration date.
- The test should remain in the sealed pouch until use.
- All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
- The used test should be discarded according to local regulations.
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 cassette from the sealed pouch and use it within one hour.
2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer
3 full drops of urine (approx. 120 uL) to the specimen well (S) of the test cassette, 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.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two lines appear. One colored line should be in the control line region (C), and another apparent colored line should be in the test line region (T). A negative result indicates that the Ethyl Glucuronide concentration is below the detectable level (500ng/mL).
*NOTE: The shade of color in the test line region (T) may vary, but it should be considered negative whenever there is even a faint colored line.
POSITIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). A positive result indicates that the Ethyl Glucuronide concentration exceeds the detectable level (500ng/mL).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test. If the problem persists, discontinue using the lot immediately and contact your local distributor.
QUALITY CONTROL
A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as good laboratory testing practice to confirm the test procedure and to verify proper test performance.
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Order Information
| Cat. No. |
Product |
Specimen |
Pack |
| DET-102 |
Ethyl Glucuronide (ETG) Rapid Test Cassette |
Urine |
40 T |
| DET-114 |
Ethyl Glucuronide (ETG) Rapid Test Panel |
Urine |
40 T |
| DET-101 |
Ethyl Glucuronide (ETG) Rapid Test Dipstick |
Urine |
50 T |
| DET-H902 |
Ethyl Glucuronide (ETG) Rapid Test Cassette |
Hair |
10 T |
