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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
INTENDED USE
The One Step Barbiturates Test uses lateral flow chromatographic immunoassay to detect Barbiturates in human urine with a cut-off concentration of 300 ng/ml. The test provides a preliminary, qualitative analytical result only. To obtain a confirmed analytical result, a more specific chemical method is required, with Gas chromatography/mass spectrometry (GC/MS) being the preferred confirmatory method. Clinical consideration and professional judgment are advised for interpreting any drug of abuse test result, especially in cases of preliminary positive results.
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