Package insert for testing of any combination of the following drugs:
Amphetamine, Amphetamine 500, Amphetamine 300, Barbiturates, Benzodiazepines, Benzodiazepines 200, Buprenorphine, Cocaine, Cocaine 150, Marijuana, Methadone, Methamphetamine, Methamphetamine 500, Methamphetamine 300, Methylenedioxymethamphetamine, Morphine 300, Opiate 2000, Oxycodone, Phencyclidine, Propoxyphene and Tricyclic Antidepressants.
A rapid, one step screen test for the simultaneous, qualitative detection of multiple drugs and metabolites in human urine.
For medical and other professional in vitro diagnostic use only.
INTENDED USE & SUMMARY
Urine based screen tests for multiple drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method to screen urine for multiple drugs of abuse.
The Multi-Drug One Step Screen Test Panel (Urine) is a lateral flow chromatographic immunoassay for the qualitative detection of following drugs without the need of instruments.1
This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert.
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.
The Multi-Drug One Step Screen Test Panel (Urine) is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody.
During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody coated on the particles. The antibody coated particles will then be captured by the immobilized drug conjugate and a visible colored line will show up in the test line region of the specific drug strip. The colored line will not form in the test line region if the drug level is above its cut-off concentration because it will saturate all the binding sites of the antibody coated on the particles.
A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.