DOA TRA One Step Tramadol Test with CE Certificate Urine uncut sheet

DOA  TRA One Step Tramadol Test with CE certificate urine uncut sheet

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.