Active Member
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[China]
Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China
Contact name:Edward YU
Hangzhou Aichek Medical Technology Co.,Ltd |
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| Product Name | ETG One Step Ethyl Glucuronide Test |
| Formats | Strip(3mm)Device(4mm) uncut sheet 300 |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 5 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
One Step Ethyl Glucuronide Test is a rapid one step test for the qualitative detection of Ethyl Glucuronide in human urine at specified cut-off level.
For healthcare professional use only. For in vitro diagnostic use only.
INTENDED USE
The One Step Ethyl Glucuronide Test is a lateral flow chromatographic immunoassay for the detection of Ethyl Glucuronide at the cut-off level of 500 ng/ml.
The assay is intended to verify an intoxication in patients. It provides a qualitative, 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 results are positive.
PERFORMANCE CHARACTERISTICS
A. Sensitivity
One Step Ethyl Glucuronide (EtG) Test has set the screen cut-off for positive specimens at 500 ng/mL for Ethyl Glucuronide as the calibrators. The test device has been proved to detect above the cut-off level of the target drugs in urine at 5 minutes.
B. Specificity and cross reactivity
To test the specificity of the test, the test device was used to test alcohol, its metabolite ethyl glucuronide and other components of the same class that are likely to be present in urine, All the components were added to drug-free normal human urine. These concentrations below also represent the limits of detection for the specified drugs or metabolites.
Component Concentration (ng/ml)
| Ethyl Glucuronide | 500 |
C. Interfering substances
Considering the complexity of clinical urine specimens and the possibility that various urine specimens contain potentially interfering substances, for example Acetaminophen, Biotin, Glucose etc., we simulated above situations by adding the potentially interfering substances to a certain concentration as specimen. The following components show no cross-reactivity when tested with One Step Ethyl Glucuronide (EtG) Test at a concentration of 100 mg/ml.
