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The OralTox® Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates, Phencyclidine, Oxycodone and Methadone in human oral fluid at the cutoff concentrations listed below and their metabolites: | Test | Calibrator | Cutoff (ng/mL) | |-----------------------|------------------------------|----------------| | Amphetamine (AMP) | d-Amphetamine | 50 | | Cocaine (COC) | Benzoylecgonine | 20 | | Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40 | | Methamphetamine (MET) | d-Methamphetamine | 50 | | Opiates (OPI) | Morphine | 40 | | Phencyclidine (PCP) | Phencyclidine | 10 | | Oxycodone (OXY) | Oxycodone | 20 | | Methadone (MTD) | Methadone | 30 | The test provides only preliminary test results. A more specific alternative chemical 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. It is not intended to detect intermittent dosing of Oxycodone. Clinical consideration and professional judgment should be exercised with any drug of abuse test result. particularly when the preliminary result is positive.

The OralTox Oral fluid Drug Test is an immunochromatographic assay that uses a lateral flow system for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Morphine, Phencyclidine. Oxycodone and Methadone (target analytes) in human oral fluid. The products are single-use in vitro diagnostic devices. Each test kit contains a test cup, a package insert and a sample collection sponge. Each test device is sealed with a desiccant in an aluminum pouch.