DOA AMP Rapid Test with CE certificate Urine uncut sheet

INTENDED USE

The One Step Amphetamine Test is a lateral flow chromatographic immunoassay for the detection of Amphetamine in human urine at the cut-off concentration of 1000 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 Amphetamine Test has set the screen cut-off for positive specimens at 1000 ng/mL for d-Amphetamine as a calibrator. The test device has been proved to detect above 1000 ng/mL of Amphetamine in urine at 5 minutes.

B. Specificity and cross reactivity

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

d-Amphetamine 1,000

d,l-Amphetamine 3,000

l-Amphetamine 50,000

(+/-) 3,4-methylenedioxyamphetamine (MDA) 5,000

Phentermine 3,000

C. Interfering substances

Considering the complexity of clinical urine specimens and the possibility that various urine specimens contain potentially interfering substances, for example Acetoacetic Acid, Acetone, Albumin etc., we simulated above situations by adding the potentially interfering substances to a certain concentration as specimen.