A rapid, one step test for the qualitative detection of Benzodiazepines in human urine.

For healthcare professionals including professionals at point of care sites.

For in vitro diagnostic use only.

MOR/MET/THC/AMP/MDMA/MTD/COC/TCA/BAR/BZO, up to 15 kinds of Drug Tests

Format: Strip, Cassette, Cup,and Panel

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.

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 it will saturate all the binding sites of anti-benzodiazepines antibody.

POSITIVE: One colored line appears in the control region (C). No line appears in the test region (T). This positive result indicates that the Benzodiazepines concentration exceeds the detectable level.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test strip. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

LIMITATIONS

1. The BZO One Step Benzodiazepines Test Strip provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. ^1,2

2. It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.

3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.

4. A Positive Result does not indicate level or intoxication, administration route or concentration in urine.

5. A Negative Result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cutoff level of the test.

6. Test does not distinguish between drugs of abuse and certain medications.