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The Oral Fluid Drug Screen Device is a rapid, one-step immunoassay for the qualitative detection of Amphetamine, Benzodiazepines, Cocaine, Methamphetamine, Morphine, Tetrahydrocannabinol, alcohol at the following cut-off concentration in human oral fluid.

This device provides only preliminary drug test results. To obtain a quantitative result or a confirmation of a presumptive positive result, a more specific alternative method must be used. GC/MS or LC/MS is the preferred confirmatory method. Professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated.

Technology and Explanation

AMP: Amphetamine is a potent sympathomimetic amine related to the human body‟s natural catecholamines, epinephrine, and norepinephrine. Depending on the route of administration, amphetamine can be detected in oral fluid as early as 10 minutes and up to 72 hours1.

BZO: Benzodiazepines are frequently prescribed sedative and hypnotic drug for treatment of anxiety, insomnia, sleep and seizure disorders. It can be detected in oral fluid up to 24 hours.

COC: Cocaine is a potent central nervous system stimulant, a local anestheticderived from the leaves of the coca plant(erythroxylum coca). Depending on the route of administration, cocaine and its metabolites benzoylecgonine can be detected in oral fluid as early as 10 minutes and up to 24 hours.

MET: Methamphetamine is a potent sympathomimetic agent with therapeutic applications. Methamphetamine use in acute higher doses lead to enhanced stimulation of the central nervous system and induce euphoria, alertness, and a sense of increased energy and power.

OPI: Heroin, morphine, and codeine are opiates that are derived from the resin of the opium poppy. Heroin is quickly metabolized to 6-acetyl morphine and morphine.

THC: Tetrahydrocannabinol, the active ingredient in marijuana plant is detectable in saliva shortly after use mainly due to the direct exposure of the drug via smoking. The window of detection for THC in saliva is up to 14 hours after use.

Test principle

OraWell® Oral Fluid Drug Screen Device is a rapid lateral fluid immunoassay utilizing monoclonal antibodies to selectively detect specific drug at above cutoff levels in human saliva. The sample collection and immunoassay testing was integrated at one step. The assay is based on competitive immunoassay procedure in which the drug conjugates immobilized on nitrocellulose membrane compete with the drugs if present in specimen for the limited amount of antibody on colloidal gold conjugates. If there is no drug present or the drug concentration in the specimen is below cutoff level, the red colloidal gold conjugate will bind to the drug conjugate at the specific test region, to form a visible band which indicated a negative results. If there is drug present in the specimen at above cutoff level, the drug will bind to the limited antibodies on colloidal gold, leaving no antibody available for binding to the drug conjugates on membrane. Thus, the absences of a test line band present at specific test region indicates a presumptive positive result for that particular drug.

Alcohol Test is an enzyme assay which a pad coated with highly specific enzymes, turns to color shades of green and blue on contact with alcohol in the oral fluids.

When oral fluid is collected has no alcohol present, the alcohol pad remains colorless. If alcohol is present in the oral fluid, the alcohol reacts with alcohol oxidase to produce aldehyde and peroxide. The peroxide reacts with peroxidase in the presence of hydrogen donor to produce a blue color. Therefore, the presence of green to blue color at the alcohol pad windowindicates a presumptive positive result for alcohol.