Abused drug rapid screening test 008SXXX

multi-drugsalivalateral flow

A rapid screening test for the simultaneous, qualitative detection of multiple drugs and metabolites in human oral fluid. For professional in vitro diagnostic use only. INTENDED USE The SalivaScreen is a lateral flow chromatographic immunoassay for the qualitative, presumptive detection of drugs of abuse in human oral fluid specimens. The SalivaScreen 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) and gas chromatography/tandem mass spectrometry (GC/MS/MS) are the preferred confirmatory methods. Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Test to monitor therapeutic measures. PRINCIPLE The SalivaScreen is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugate for binding sites on their specific antibody. During testing, a portion of the oral fluid specimen migrates upward by capillary action. A drug, if present in the oral fluid specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible coloured line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration in the oral fluid specimen will saturate all the binding sites of the antibody. Therefore, the coloured line will not form in the test line region.