ETG One Step Ethyl Glucuronide Test with CE Certificate Urine Uncut
sheet
| 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)
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.
