The Pan Probe Biotech, Inc., LiveSure^TM Tricyclic Antidepressant Screen Test is an in vitro diagnostic (IVD), qualitative, lateral flow, immunochromatographic urinary assay for the rapid detection of tricyclic antidepressant (TCA) and its metabolites in human urine at the Substance Abuse Mental Health Services Administration (SAMHSA) cut-off level of 1000 ng/ml.  Tricyclic antidepressant (TCA) is commonly used for the treatment of depressive disorders.  High dose abuse of TCA can result in profound central nervous system depression, cardiotoxicity and anticholinergic effects.  TCA overdose is the most common cause of death from prescription drugs.  TCA is taken orally or sometimes by injection.  The LiveSure^TM TCA Screen Test is a competitive immunoassay in which chemically modified and bound TCA conjugate competes with urinary TCA and its metabolites for limited, specific TCA antibody binding sites.  Each test device contains a sample reaction unit, a pink-colored, antibody-colloidal gold conjugate unit pre-labeled with specific antibody, and a chromatographic membrane pre-coated with drug conjugate in the device test region.