The Benzodiazepines Screen Test Card and Test Strip devices are in vitro diagnostic (IVD), lateral flow, immunochromatographic, qualitative urinary assays for the rapid detection of benzodiazepine and its metabolites in human urine at the Substance Abuse Mental Health Services Administration (SAMHSA) cut-off level of 300 ng/mL. The tests are designed to obtain a visual, qualitative result and are intended for professional use only. They are not intended for quantitative results, or for over-the-counter sale. The Benzodiazepines Screen Test provides only preliminary analytical data. A more specific, alternative method is required to obtain a confirmed analytical result. SAMHSA has established gas chromatography/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
The Benzodiazepines Screen Test has been designed for the detection of benzodiazepine and its metabolites in urine at the detection sensitivity of 300 ng/ml, as suggested for immunoassay methods by SAMHSA. In sensitivity studies performed, concentrations