DOA MTD One Step Methadone Test with CE Certificate Urine uncut sheet

DOA MTD One Step Methadone Test with CE certificate urine uncut sheet

One Step Methadone Test is a rapid one step test for the qualitative detection of Methadone 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 Methadone Test is a lateral flow chromatographic immunoassay for the detection of Methadone in human urine at the cut-off concentration of 300 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 positive results are used.

PERFORMANCE CHARACTERISTICS

A. Sensitivity

One Step Methadone Test has set the screen cut-off for positive specimens at 300 ng/mL for Methadone. The test device has been proved to detect above 300ng/mL of Methadone in urine at 5 minutes.

B. Specificity and cross reactivity

To test the specificity of the test, the test device was used to test Methadone, drug metabolites and other components 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)

Methadone 300

Doxylamine 50,000

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 Morphine Test at a concentration of 100 mg/ml.

SUMMARY

Methadone is a synthetic analgesic drug that is originally used in the treatment of narcotic addicts. Among the psychological effects induced by using methadone are analgesia, sedation and respiratory depression. Overdose of methadone may cause coma or even death. It is administered orally or intravenously and is metabolized in the liver and excreted in urine as methadone, EDDP, EMDA and methadol. The kinneys are a major route of methadone excretion. Methadone has a biological half-life of 15 to 60 hours.