Amphetamine- AMP Rapid Test Cassette (Urine), Drug Abuse Test Kit,1,000ng/mL cut-off
| Principle |
Chromatographic Immunoassay |
| Format |
Dipstick, Cassette, Panel, Device, Cup |
| Specimen |
Urine,Oral Fluid,Powder,WB/S/P,Hair |
| Certificate |
CE/FDA |
| Reading Time |
5 minutes |
| Pack |
10T/25T/40T/50T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
| Sensitivity |
99.10% |
| Specificity |
98.50% |
| Accuracy |
98.80% |
A rapid test for the qualitative detection of Amphetamine in human urine. For medical and other professional in vitro diagnostic use only.
INTENDED USE
The AMP Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the detection of Amphetamine in human urine at a cut-off concentration of 1,000ng/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 Rapid Test Device (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 Rapid Test Cassette (Urine) yields a positive result when Amphetamines in urine exceed 1,000 ng/mL.
PRINCIPLE
The AMP Rapid Test Cassette (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. 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 because of drug competition, while a drug-negative 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.
REAGENTS
The test contains mouse monoclonal anti-Amphetamine antibody-coupled particles and Amphetamine-protein conjugate. A goat antibody is employed in the control line system.
PRECAUTIONS
For medical and other professional in vitro diagnostic use only. Do not use after the expiration date.
The test 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 should be discarded according to local regulations.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
DIRECTIONS FOR USE
Allow the test, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.
2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 120 uL) to the specimen well (S) of the test cassette, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below.
3. Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two lines appear. One colored line should be in the control line region (C), and another apparent colored line should be in the test line region (T). This negative result indicates that the Amphetamine concentration is below the detectable level (1,000 ng/mL).
*NOTE: The shade of color in the test line region (T) may vary, but it should be considered negative whenever there is even a faint colored line.
POSITIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). This positive result indicates that the Amphetamine concentration exceeds the detectable level (1,000 ng/mL).
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. If the problem persists, discontinue using the lot immediately and contact your local distributor.
QUALITY CONTROL
A procedural control is included in the test. A colored line appearing in the control line 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.
| DAM-102 |
Amphetamine (AMP) Rapid Test Cassette |
Urine |
40T |
| DAM-114 |
Amphetamine (AMP) Rapid Test Panel |
Urine |
40 T |
| DAM-101 |
Amphetamine (AMP) Rapid Test Dipstick |
Urine |
50 T |
| DAM-802 |
Amphetamine (AMP) Rapid Test Cassette |
Oral Fluid |
25 T |
| DAM-803 |
Amphetamine (AMP) Rapid Test Device |
Oral Fluid |
25 T |
| DAM-402 |
Amphetamine (AMP) Rapid Test Cassette |
WB/S/P |
40 T |
| DAM-X14 |
Amphetamine (AMP) Rapid Test Panel |
Powder |
25 T |
| DAM-H902 |
Amphetamine (AMP) Rapid Test Cassette |
Hair |
10 T |
US FDA OTC Cleared - Citest DOA Rapid Tests
In recent times, the issue of drug abuse has become increasingly rampant. Citest has been dedicated to combating this problem and making a positive impact.
We are proud to announce that several of our DOA rapid tests got US FDA OTC successfully registered. This recognition from the US FDA signifies the quality and reliability of our products. Our DOA product line covers a wide range of drug detections, including AMP, BAR, COC, and more. We offer a diverse selection of test formats to meet the specific needs of our customers. Our tests are of high quality, trustworthy, resistant to tampering, and highly accurate. We aim to contribute to the efforts of drug enforcement agencies, hospitals, and courts in various regions by providing them with effective tools to combat drug abuse.
Citest remains committed to innovation and continuous research and development to meet the evolving needs of our customers and address the societal challenges associated with drug abuse.
