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TUBI's UNISCAN-DoA is a system intended for use in Drugs of Abuse Screening Tests. This mAMP/Opi/THC panel test is a prescription assay intended for use with UNISCAN-DoA scanner in laboratory by professional personnel. The mAMP/Opi/THC assays were calibrated with d-methamphetamine/morphine/11-nor-△-THC-9-COOH, respectively. It provides qualitative screening results for Methamphetamine/ Opiate/cannabinoids in human urine at a cutoff concentration of 1000/300/50 ng/ml. For In Vitro Diagnostic Use. This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any Drug of Abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the recommended confirmatory method.

The UNISCAN-DoA system includes UNISCAN-DoA scanner and mAMP/Opi/THC panel test. The UNISCAN-DoA scanner is a scientific measurement device for color intensity of developed test strip. The color intensity of a test line is detected by the contact image sensor (CIS) inside the device. The test strip of UNISCAN-DoA system is a one-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Methamphetamine, Opiates, and THC (Cannabinoid). The device contains a membrane strip, which is pre-coated with drug-protein conjugate at the test region of the membrane strip. A wicking pad containing anti-drug monoclonal antibody-conjugate is placed at one end of the membrane. The device contains a control region which has a different antigen/antibody from the test region. The assay relies on the competition for binding antibody between drug conjugate and free drug that may be present in the urine specimen being tested. When drug is present in the urine specimen, it competes with drug conjugate for limited amount of antibody-colloidal gold conjugate. If the drug is present in the urine specimen, it will prevent the binding of drug conjugate to the antibody. Therefore, the color intensity of the test line is reduced. The higher the drug concentration is present in the urine specimen, the lower the color intensity is in the test line of a strip. The color intensity of a test line is inversely proportional to the drug concentration in the urine specimen. The correlation between the color intensity and the drug concentration is described by a calibration curve, whose coefficients are determined via nonlinear regression based on the experimental data. The calibration curve equation and its coefficients are stored in UNISCAN-DoA scanner. Once a developed test strip is inserted into the scanner and is scanned by the device, the color intensity of a test line is detected by the contact image sensor (CIS) inside the device and the signal is converted to drug concentration according to the stored calibration curve equation and its coefficients. The qualitative result is then displayed on the LCD screen of the device. A control line is present at the control region to work as procedural control. This colored band should always appear at the control region regardless the presence of drugs or metabolite. The UNISCAN-DoA scanner automatically detects the color intensity of a control line. If the control line of an inserted test strip does not be detected by the device, "Strip is Failed!" will be displayed on the LCD screen of the device.