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DRUG SCREEN TEST SPECIFICATIONS
INTENDED USE
A rapid, screening test that is a lateral flow chromatographic immunoassay for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine at the following cut-off concentrations. For in vitro diagnostic use only.
TEST | CALIBRATOR | CUT-OFF |
---|---|---|
Amphetamine (AMP) | D-Amphetamine | 1,000 ng/mL |
Barbiturates (BAR) | Secobarbital | 300 ng/mL |
Benzodiazepines (BZO) | Oxazepam | 300 ng/mL |
Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
Marijuana (THC) | 11-nor-D9-THC-9 COOH | 50 ng/mL |
Methadone (MTD) | Methadone | 300 ng/mL |
Methamphetamine (mAMP) | D-Methamphetamine | 1,000 ng/mL |
Methylenedioxymethamphetamine (MDMA) (Ecstasy) | D,L Methylenedioxymethamphetamine | 500 ng/mL |
Morphine (MOP 300 or OPI 300) | Morphine | 300 ng/mL |
Opiates (OPI 2000) | Morphine | 2,000 ng/mL |
Oxycodone (OXY) | Oxycodone | 100 ng/mL |
Phencyclidine (PCP) | Phencyclidine | 25 ng/mL |
Tricyclic (TCA) | Nortriptyline | 1,000 ng/mL |
The configurations of the Drug Screen Test come with any combination of the above listed drug analytes. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
SUMMARY: The Test is a rapid urine screening test that can be performed without the use of an instrument. The test ultilizes a monoclonal antibody to selectively detect elevated levels of specific drugs in urine.