99.8% ISO Certification Rapid Test Cassette

One Step AMP Test Device Urine Drug Test Kits diagnostic

One Step AMP Test Device Urine Drug Test Kits diagnostic

Intended Use:

The AMP One Step Amphetamine Test Device is a lateral flow chromatographic immunoassay for the detection

of Amphetamines in human urine.

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 presecription (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 does 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 Device 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 Amphetamines in urine.

The AMP One Step Amphetamine Test Device yields a positive result when Amphetamines in urine exceed 1,000 ng/mL.

Warnings and Precautions:

· For in vitro diagnostic use only.

· For healthcare professionals and professionals at point of care sites.

· Do not use after the expiration date.

· Please read all the information in this leaflet before performing the test.

· The test panel should remain in the sealed pouch until use.

· All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

· The used test panel should be discarded according to federal, state and local regulations.

Storage and Stablity:

· Store as packaged in the sealed pouch at room temperature (2-30℃ or 36-86℉). The kit is stable within

the expiration date printed on the labeling.

· Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid

environment will cause product deterioration.

Specimens:

· The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day

may be used. Urine specimens exhibiting visible precipitates should be centrifuged, filtered, or allowed to

settle to obtain a clear supernatant for testing.

· Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For prolonged storage, specimens

may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed well before testing.

Test Procedure:

Allow the test and urine samples to equilibrate to room temperature (15-30℃or 59-86℉) prior to testing.

1. Remove the test cassette from the sealed pouch.

2. Hold the dropper vertically and transfer 3 full drops (approx. 100ml) of urine to the specimen well of the test

cassette, and then begin timing. See the illustration below.

3. Wait for colored lines to appear. Interpret the test results at 3-5 minutes. Do not read results after 10 minutes.

Interpretation of Result:

Negative: *Two lines appear. One red line should be in the control region (C), and another apparent red

or pink line adjacent should be in the test region (T). This negative result indicates that the drug concentration

is below the detectable level.

*NOTE:The shade of red in the test line region (T) will vary, but it should be considered negative whenever

there is even a faint pink line.

Positive: One red line appears in the control region (C). No line appears in the test region (T). This positive

result indicates that the drug concentration is above the detectable level.

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the

most likely reasons for control line failure. Review the procedure and repeat the test using a new test panel.

If the problem persists, discontinue using the lot immediately and contact your local distributor.

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