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One Step Amphetamine Test Strip (Urine)

A rapid, one step test for the qualitative detection of Amphetamine in human urine.
For professional in vitro diagnostic use only.

INTENDED USE

The AMP One Step Amphetamine Test Strip (Urine) is a lateral flow chromatographic immunoassay for the detection of Amphetamine in human urine at a cut-off concentration of 1,000 ng/mL. This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert.
This assay provides only a 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.

SUMMARY

Amphetamine is a Schedule II controlled substance available by prescription (Dexedrine®) and is also available on the illicit market. Amphetamines are a class of potent sympathomimetic agents with therapeutic applications. They are chemically related to the human body’s natural catecholamines: epinephrine and norepinephrine. Acute higher doses lead to enhanced stimulation of the central nervous system and induce euphoria, alertness, reduced appetite, and a sense of increased energy and power.
Cardiovascular responses to Amphetamines include increased blood pressure and cardiac arrhythmias.
More acute responses produce anxiety, paranoia, hallucinations, and psychotic behavior. The effects of Amphetamines generally last 2-4 hours following use, and the drug has a half-life of 4-24 hours in the body. About 30% of Amphetamines are excreted in the urine in unchanged form, with the remainder as hydroxylated and deaminated derivatives.
The AMP One Step Amphetamine Test Strip (Urine) is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Amphetamine in urine. The AMP One Step Amphetamine Test Strip (Urine) yields a positive result when Amphetamines in urine exceed 1,000 ng/mL.

PRINCIPLE

The AMP One Step Amphetamine Test Strip (Urine) is a rapid chromatographic immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary action. Amphetamine, if present in the urine specimen below 1,000 ng/mL, will not saturate the binding sites of the antibody coated particles in the test strip. The antibody coated particles will then be captured by immobilized Amphetamine conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Amphetamine level exceeds 1,000 ng/mL because it will saturate all the binding sites of anti-Amphetamine antibodies.
A drug-positive urine specimen will not generate a colored line in the test line region, while a drugnegative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.





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