DRUG SCREEN TEST SPECIFICATIONS
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.
|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.