Drug Test kits AMP Rapid test strip ,4mm test strip. Urine Specimen
for Amphetamine, Gold colloidal method
Intended Use
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 Amphetamines in urine. The AMP One Step
Amphetamine Test Strip (Urine) yields a positive result when
Amphetamines in urine exceed 1,000 ng/mL
The AMP Rapid Test Strip (Urine) is a rapid visual immunoassay for
the qualitative, presumptive detection of Amphetamine in human
urine specimens at the cut-off concentrations listed below:
| Parameter | Calibrator | Cut-off(ng/mL) |
| AMP (Amphetamine) | d-Amphetamine
| 1,000 |
| | |
Test 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 1000
ng/mL, will not saturate the binding sites of 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 1000 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 drug-negative urine specimen or a
specimen containing a drug in a concentration less than the cut-off
will generate a colored 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.
DIRECTIONS FOR USE
Bring tests, specimens, and/or controls to room temperature
(15-30°C) before use.
Remove the test from its sealed pouch, and place it on a clean,
level surface. Label the test with patient or control
identification. For best results, the assay should be performed
within one hour.
Using the provided disposable pipette, transfer 3 drops of specimen
(approximately 120 µL) to the specimen well (S) of the device and
start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add
any solution to the result area.
As the test begins to work, color will migrate across the membrane.
Wait for the colored band(s) to appear. The result should be read
at 5 minutes. Do not interpret the result after 8 minutes
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* A colored line appears in the Control region (C) and
colored lines appears in the Test region (T). This negative result
means that the concentrations in the urine sample are below the
designated cut-off levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the Test region (T) may
vary. The result should be considered negative whenever there is
even a faint line.
POSITIVE: A colored line appears in the Control region (C) and NO
line appears in the Test region (T). The positive result means that
the drug concentration in the urine sample is greater than the
designated cut-off for a specific drug.
INVALID: No line appears in the Control region (C). Insufficient
specimen volume or incorrect procedural techniques are the most
likely reasons for Control line failure. Read the directions again
and repeat the test with a new test card. If the result is still
invalid, contact your manufacturer.
QUALITY CONTROL
A procedural control is included in the test. A line appearing in
the control region
(C) is considered an internal procedural control. It confirms
sufficient specimen volume, adequate membrane wicking and correct
procedural technique.
Control standards are not supplied with this kit. However, it is
recommended that positive and negative controls be tested as good
laboratory practice to confirm the test procedure and to verify
proper test performance.
Analytical Sensitivity
A drug-free urine pool was spiked with Amphetamine at the following
concentrations: 0 ng/mL, 500 ng/mL, 750 ng/mL, 1,000 ng/mL, 1,250
ng/mL, 1,500 ng/mL and 2,000 ng/mL. The result demonstrates >
99% accuracy at 50% above and 50% below the cut-off concentration.
Results are presented in Table 2 below.
Table 2: Analytical Sensitivity Summary
| AMP Concentration (ng/mL) | Percent of Cut-off | n | Visual Result |
| Negative | Positive |
| 0 | 0 | 30 | 30 | 0 |
| 500 | -50% | 30 | 30 | 0 |
| 750 | -25% | 30 | 22 | 8 |
| 1000 | Cut-off | 30 | 12 | 18 |
| 1,250 | +25% | 30 | 2 | 28 |
| 1,500 | +50% | 30 | 0 | 30 |
| 2,000 | +100% | 30 | 0 | 30 |
Conclusion: As indicated in table above: all specimens with AMP concentration
equal to or lower than 500ng/mL show negative results, all
specimens with AMP concentration of 1000ng/mL are identified as
“+/-”, and all specimens with AMP concentration equal to or higher
than 1500ng/mL showed positive results. Therefore, the cut-off
concentration of the AMP One Step Test Strip (Urine) is determined
to be 1000ng/mL AMP.
Analytical Specificity
Table 3 lists the compounds that are positively detected in urine
by the AMP One Step Amphetamine Test Strip (Urine) at 5 minutes and
the concentrations at which they are detected.
Table 3: Analytical Specificity
| Compound | Concentration (ng/mL) |
| D-Amphetamine | 1,000 |
| D,L-Amphetamine sulfate | 3,000 |
| L-Amphetamine | 50,000 |
| (±) 3,4-Methylenedioxyamphetamine | 2,000 |
| Phentermine | 3,000 |
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
