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INTENDED USE
The QuickScreen™ One-Step Rapid
Methamphetamine Test is a rapid, visual, qualitative, competitive binding immunoassay for the
detection of Methamphetamine and amphetamine metabolites in human urine. The
test provides a fast confirmation of the presence of
Methamphetamine in the subject sample at a minimum cutoff sensitivity level of
500 ng/ml M-AMP, the sensitivity level set by the National Institute on Drug
Abuse and Departments of Health and Human Services. Note: Where indicated, any
positive test should be confirmed using quantitative methods by a qualified
testing laboratory. Note: This assay provides only a preliminary analytical test result. A more specific alternative chemical method such as high-pressure liquid chromatography (HPLC) or Gas chromatography/mass spectrometry (GC/MS) must be used in order to obtain a confirmed analytical result. For test situations requiring laboratory confirmation by such methods please refer to the QuickScreen Pro At Home Test Kit. Clinical consideration and professional judgment should be applied to all test results, particularly when preliminary positive results are indicated. SUMMARY AND EXPLANATION OF THE TEST Methamphetamine is a serious drug of abuse. Recently, a form of methamphetamine with a street name "Ecstasy" has become a fashionable drug among teenagers and young adults. Surveys and clinical studies have confirmed that Methamphetamine is a highly addictive and dangerous drug causing severe behavioral, physical and emotional abnormalities. After oral administration, the major psychoactive compound, amphetamine, is extensively metabolized before excretion. The excretion half-life of Methamphetamine metabolized in urine, estimated by different techniques, ranges from three to five days. For an initial immunoassay result, a cutoff value of 500 ng/ml total amphetamine metabolites is required by the mandatory reference guidelines from the U.S. Department of Health and Human Services. All presumptive positive results must be confirmed at a cutoff concentration of 500 ng/ml methamphetamine or amphetamine derivative. The QuickScreen™ One-Step Methamphetamine Test employs a unique combination of monoclonal antibodies to selectively identify methamphetamine metabolites in urine with the high degree of sensitivity required by official guidelines. This test device is a rapid, visually read screening test that does not require instrumentation and provides a fast indication of recent methamphetamine consumption. For comprehensive information on drug testing including typical half-life or drug detection periods see the Drug Testing FAQ. The QuickScreen™ One-Step Rapid Methamphetamine Test utilizes a unique combination of monoclonal antibodies to selectively identify Methamphetamine and its major metabolites in urine with a high degree of sensitivity. The test kit is a rapid, visually read screening method that does not require special instrumentation or training. PRINCIPLE The QuickScreen™ One-Step Rapid Methamphetamine Test technology incorporates a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a Methamphetamine derivative immobilized on a porous membrane for limited antibody sites. This is the preferred scientific method for qualitative assay. In the assay procedure, urine mixes with labeled antibody-dye conjugate and migrates through test device. When Methamphetamine levels are below 500 ng/ml (the detection cutoff sensitivity of the test) unbound antibody-dye conjugate binds to immobilized antigen conjugate in the Test Zone ("T"), producing a pink-rose colored band that indicates a negative result. Conversely, when Methamphetamine levels are above the detection limit, antibody-dye conjugate binds to the free drug, forming an antigen-antibody-dye complex. The complex competes with immobilized antigen conjugate in the Test Zone, preventing the development of a pink-rose colored band. Regardless of the test result, a color band is produced in the Control Zone ("C") by a non-specific sandwich dye conjugate reaction. This band serves as a built-in quality control by demonstrating antibody recognition, verifying that the reagents are chemically active, and confirming that the test was performed correctly. MATERIALS PROVIDED: Test Device and Dropper Pipette individually sealed in foil pouch with complete instructions. ASSAY PROCEDURE
INTERPRETATION OF TEST RESULTS:
Positive: One (1) pink-rose band appears in the control zone and no band appears in the test zone. A positive result indicates the Methamphetamine level is
500 ng/ml or higher in the test urine sample. The QuickScreen™ One-Step Rapid Methamphetamine test is now available to professionals and individuals concerned with Methamphetamine abuse. The test is one-step, fast, self-contained, individually packaged and can be performed any time the targeted drug use or abuse is suspected. The tests come in order units of five (5) individual tests at a cost per single diagnosis/screen of $4.00 for the minimum order unit. For testing situations where sample adulteration is suspect, a Rapid Urine Adulteration test is available.
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