Description

The Cortez Diagnostics, Inc. Benzodiazepine RapiDip™ Rapid Test is an immunochromatography based onestep in vitro test. It is designed for qualitative determination of
Benzodiazepines and their metabolites in human urine specimens above a cut-off level of 300 ng/ml oxazepam. This assay may be used in the point of care setting. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMHSA). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Benzodiazepines are a class of widely prescribed central nervous system depressants which have anxiolytic, hypnotic, anticonvulsant and muscle relaxant effects. Chronic abuse can result in addiction and tardive dyskinnesia. Acute higher doses lead to drowsiness, dizziness, muscle relaxation, lethargy, coma and possible death. The effects of benzodiazepines use last 4 – 8 hours. Many of the benzodiazepines share a common metabolic route, and are excreted as oxazepam and its glucuronide in urine. Oxazepam is detectable in the urine for up to 7 days after drug use. However, the length of time following drug use for which a positive result may occur is dependent upon several factors, including the frequency and amount of drug, metabolic rate, excretion rate, drug half-life, and the drug user’s age, weight, activity, and diet.

The Cortez Diagnostics, Inc. Benzodiazepine RapiDip™ Rapid Test is based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for binding antibody between drug conjugate and free drug which may be present in the urine specimen being tested. When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibody-dye conjugate. When the amount of drug is equal or more than the cut-off, 300 ng/ml of oxazepam, it will prevent the binding of drug conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result. A control line is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.