RAPID METHADONE (MTD) TEST STRIP
INTENDED USE
The Rapid Methadone (MTD) Test Strip is an immunochromatography based one step in vitro test. It is designed for qualitative determination of methadone in human urine specimens above a cut-off level of 300 ng/ml. The Rapid Methadone (MTD) Test Card assay may be used in the point of care setting.
This Rapid Methadone (MTD) Test Card assay provides only a preliminary analytical test result. A more specific alternative chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are
indicated.
SUMMARY AND EXPLANATION
Methadone is a synthetic opioid, clinically available. It is used clinically for the treatment of severe pain and in maintenance programs for morphine and heroine addicts. Methadone acts on the central nervous and cardiovascular systems to produce respiratory and circulatory depression. Methadone also produces miosis and increases the tone of smooth muscle in the lower gastrointestinal tract while decreasing the amplitude of contractions. Acute higher doses induce analgesia, sedation, respiratory depression and coma.
After methadone administration, the major urinary excretion products are methadone and its metabolites, EDDP and EMDP. Large individual variations in the urine excretion of methadone are output of methadone from 5-22%. Typically, following a 5 mg oral dose, methadone and EDDP account for 5% of the dose in the 24-hour urine. In those individuals on maintenance therapy, methadone may account for 5 to 50% of the dose in the 24-hour urine and EDDP may account for 3 to 25% of the dose..
TEST PRINCIPLE
Rapid Methadone (MTD) Test Strip
The Rapid Methadone (MTD) test strip 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 mouse anti-methadone monoclonal antibody between methadone-protein conjugate and free drug which may be present in
the urine specimen being tested.
When methadone is present in the urine specimen, it competes with methadone-protein conjugate for the limited amount of monoclonal antibody-colloidal gold conjugate. When the amount of methadone is equal or more than the cut-off, it will prevent the binding of methadone-protein 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 composed of Goat anti-Mouse IgG antibody 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.
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