DOA TRA One Step Tramadol Test with CE certificate urine uncut
sheet
| Product Name | TRA One Step Tramadol Test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 5 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| Storage | 2℃-30℃ |
One Step Tramadol Test is a rapid one step test for the qualitative
detection of tramadol and its principal metabolites in human urine
at specified cut-off level.
For in vitro diagnostic use only. For professional use only.
INTENDED USE
The One Step Tramadol Test is a lateral flow chromatographic
immunoassay for the detection of Tramadol in human urine at the
cut-off concentration of 100 ng/ml. This assay provides only 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 Tramadol Test has set the screen cut-off for positive
specimens at 100 ng/mL for tramadol as a calibrator. The test
device has been proved to detect above 100 ng/mL of tramadol in
urine at 5 minutes.
B. Specificity and cross reactivity
To test the specificity of the test, the test device was used to
test tramadol, its metabolites 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)
Tramadol 100
(+/-)Chlorpheniramine 500,000
Dipehnhydramine 250,000
Pheniramine >500,000
PCM >250,000
C. Interfering substances
Considering the complexity of clinical urine specimens and the
possibility that various urine specimens contain potentially
interfering substances, for example Acetoacetic Aci, Acetone,
Albumin 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 Tramadol Test at a concentration of 100 mg/ml.
SUMMARY
Tramadol is used similarly to codeine, to treat moderate to
moderately severe pain. It is a synthetic analog of the
phenanthrene alkaloid codeine and, as such, is an opioid and also a
prodrug (codeine is metabolized to morphine, tramadol is converted
to O-desmethyltramadol). Tramadol and its metabolites are excreted
primarily in the urine with observed plasma half-lives of 6.3 and
7.4 hours for tramadol and O-desmethyltramadol(denoted M1),
respectively. Approximately 30% of the dose is excreted in the
urine as unchanged drug, whereas 60% of the dose is excreted as
metabolites.
