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The MP RapidOXY Test Strip is an immunochromatographic one-step in-vitro test designed for qualitative determination of oxycodone in human urine specimens above a cut-off level of 100 ng/ml. The MP RapidOXY Test Strip may be used in a point-of-care (POC) setting and will provide 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. The MP RapidBUP Test Strip is an immunochromatography based one step in vitro test. It is designed for qualitative determination of the major metabolite of buprenorphine, buprenorphine-3-beta-d-glucuronide, in human urine specimens at cut-off level of 10 ng/ml. The MP RapidBUP Test Strip may be used in a point-of-care (POC) setting and will provide 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.

The MP RapidOXY Test Strip and the MP RapidBUP Test Strip are based on the principle of specific immunochemical reaction between antibody and antigen to analyze particular compounds in human urine specimens. The assays rely on the competition for binding antibody between drug conjugate and free drug which may be present in urine. When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibodydve conjugate. When the amount of drug is equal or more than the cut-off (i.e., 100 ng/ml oxycodone or 10 ng/ml buprenorphine-3-beta-d-glucuronide, or B-3-beta-d-G), 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 in both assays. 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.