DOA OXY One Step Oxycodone Test with CE certificate urine uncut sheet

One Step Oxycodone Test is a rapid one step test for the qualitative detection of Oxycodone and its principal metabolites in human urine at specified cut-off level.

For in vitro diagnostic use only. For healthcare professional use only.

INTENDED USE

The One Step Oxycodone Test is a lateral flow chromatographic immunoassay for the detection of Oxycodone 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 positive results are used.

PERFORMANCE CHARACTERISTICS

A. Sensitivity

One Step Oxycodone Test has set the screen cut-off for positive specimens at 100 ng/mL for Oxycodone as a calibrator. The test device has been proved to detect above 100 ng/mL of Oxycodone in urine at 5 minutes.

B. Specificity and cross reactivity

To test the specificity of the test, the test device was used to test Oxycodone, 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)

Oxycodone 100

Dihydrocodeine 20,000

Codeine 100,000

Hydromorphone 100,000

Morphine > 100,000

Acetylmorphine > 100,000

Buprenorphine > 100,000

Ethylmorphine > 100,000

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 Oxycodone Test at a concentration of100 µg/ml.