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The Oratect Oral fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The Oratect tests detect these drugs at the cutoff concentration listed below. | Test | Cutoff | |---------------------------------------------------------------------|----------| | Oratect® Oral Fluid Drug Screen Device d-Amphetamine | 50 ng/mL | | Oratect® Oral Fluid Drug Screen Device d-Methamphetamine | 50 ng/mL | | Oratect® Oral Fluid Drug Screen Device Delta-9-Tetrahydrocannabinol | 40 ng/mL | | Oratect® Oral Fluid Drug Screen Device Cocaine | 20 ng/mL | | Oratect® Oral Fluid Drug Screen Device Morphine | 40 ng/mL | | Oratect® Oral Fluid Drug Screen Device Phencyclidine | 10 ng/mL | These products are for in vitro diagnostic use and intended for prescription point of care use. The Orated® Oral Fluid Drug Screen Device provides only preliminary drug test results. A more specific alternative method must be used in order to obtain a confirmed analytical result. Liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS) is the preferred confirmatory method. Samples for confirmatory testing should be collected with the Oratect® Oral Fluid Collection Tube (50 mL polypropylene tube) provided. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels. OratectCheck™ Oral Fluid Controls (Negative and Positive controls of the analytes) are available but not supplied with the Oratect Oral Fluid Drug Screen Devices. The OratectCheck™ Oral Fluid Controls are used as quality control materials with Oratect® Oral Fluid Drug Screen Devices.

The Oratect® Oral Fluid Drug Screen Device is a one-step lateral flow immunoassay device for the qualitative detection of d-Methamphetamine (ME), Delta-9-Tetrahydrocannabinol (TH), Cocaine (CO), d-Amphetamine (AM), Morphine (OP) and Phencyclidine (PC) in human oral fluid. The test principle is a competitive lateral flow immunochromatographic assay. The presence of analyte will produce a negative signal.

The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are rapid immunochromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a cut-off concentration of 10 ng/ml. The devices are intended for professional use only. They are not intended for over-the-counter sale to non-professionals. The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard tests are used to obtain visual, qualitative results. A more specific alternate method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS are the preferred confirmatory methods.

The Fastect® II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard are based on the principle of highly specific immunochemical reactions between antigens and antibodies. Both devices utilize a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites. If Buprenorphine is present in the urine, it competes with the immobilized drug conjugate for the limited binding sites on the colored antibody colloidal gold conjugate. When a sufficient amount of drug is present, the drug will saturate the antibodies, and the colored colloidal gold conjugate cannot bind to the drug conjugate immobilized on the membrane. Thus, the absence of the purple-red band at the test region indicates a preliminary positive result. However, if there is no drug present to compete for the binding sites of the colored colloidal gold conjugate, it binds to the immobilized drug conjugate to form a visible purple-red band at the test region of the membrane. Thus, the presence of a purple-red band at the test region indicates a negative result. The Fastect II BUP Drug Screen Dipstick and QuickTox® Drug Screen Dipcard devices are standardized to detect Buprenorphine in human urine at a cut-off concentration of 10 ng/ml. These tests can be performed without the use of any additional instruments. A control band with a different antigen/antibody reaction is added to the immunochromatographic membrane strip and should always appear regardless of the presence of drug or metabolite. The appearance of the control band during testing indicates that the test has completed and the test is valid.