One-Step BZO Rapid Test

INTENDED USE

The BZO One Step Benzodiazepines Test Strip is a lateral flow chromatographic immunoassay for the detection of Oxazepam (major metabolite) in urine at a cut-off concentration of 300 ng/mL. This test will detect other Benzodiazepines, please refer to 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.

SUMMARY

Benzodiazepines are medications that are frequently prescribed for the symptomatic treatment of anxiety and sleep disorders.  They produce their effects via specific receptors involving a neurochemical called gamma aminobutyric acid (GABA).  Because they are safer and more effective, Benzodiazepines have replaced barbiturates in the treatment of both anxiety and insomnia.  Benzodiazepines are also used as sedatives before some surgical and medical procedures, and for the treatment of seizure disorders and alcohol withdrawal.

Risk of physical dependence increases if Benzodiazepines are taken regularly (e.g., daily) for more than a few months, especially at higher than normal doses.  Stopping abruptly can bring on such symptoms as trouble sleeping, gastrointestinal upset, feeling unwell, loss of appetite, sweating, trembling, weakness, anxiety and changes in perception. 

Only trace amounts (less than 1%) of most Benzodiazepines are excreted unaltered in the urine; most of the concentration in urine is conjugated drug.  The detection period for the Benzodiazepines in the urine is 3-7 days.

The BZO One Step Benzodiazepines Test Strip is a rapid urine-screening test that can be performed without the use of an instrument. The test utilizes the antibody to selectively detect elevated levels of Benzodiazepines in urine. The BZO One Step Benzodiazepines Test Strip yields a positive result when the Benzodiazepines in urine exceeds cut-off concentration. 

PRINCIPLE

The BZO One Step Benzodiazepines Test Strip is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

During testing, a urine specimen migrates upward by capillary action. Benzodiazepines, if present in the urine specimen below cut-off, will not saturate the binding sites of the antibodies in the test strip. The antibody coated particles will then be captured by immobilized benzodiazepine-protein conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the benzodiazepines level exceeds cut-off concentration, because itwill saturate all the binding sites of anti-benzodiazepines antibody.

A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration lower 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.

REAGENTS

The test strip contains mouse monoclonal anti-Benzodiazepines antibody-coupled particles and benzodiazepines-protein conjugate. A goat antibody is employed in the control line system.