Description

The Cortez Diagnostics, Inc. MDMA RapiDip™ Rapid Test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of Methylenedioxymethamphetamine (MDMA) in human urine specimens above a cut-off level of 500 ng/ml. This assay may be used in the point of care setting. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. MDMA, most commonly known today by the street name ecstasy (offen abbreviated to E, X, or XTC), is a semisynthetic entactogen of the phenethylamine family. The primary effects of MDMA include feelings of openness, euphoria, empathy, love, and heightened self-awareness, the short-term health risks of taking MDMA include hypertension, dehydration and hyperthermia, the effects of long-term use in humans are debatable and the subject of much controversy, particularly with regard to the risks of severe long-term depression as a result of a reduction in the natural production of serotonin. Ecstasy affects the regulation of the body’s internal system, the use of ecstasy can be very dangerous when combined with other drugs. The Cortez Diagnostics, Inc. MDMA RapiDip™ Rapid Test is based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for binding antibody between drug conjugate and free drug which may be present in the urine specimen being tested. When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibody-dye conjugate. When the amount of drug is equal or more than the cut-off 500 ng/ml, it will prevent the binding of drug conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result. A control line is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.