BZO Rapid Test Cassette (Urine), Oxazepam (major metabolite), drug
of abuse,CE/FDA
| Principle | Chromatographic Immunoassay |
| Format | Dipstick, Cassette, Panel, Device, Cup |
| Specimen | Urine,Oral Fluid,Powder,WB/S/P,Hair |
| Certificate | CE/FDA |
| Reading Time | 5 minutes |
| Pack | 10T/25T/40T/50T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 98.20% |
| Specificity | 97.80% |
| Accuracy | 98.00% |
| Cut-Off | 100 ng/mL, 200 ng/mL, 300 ng/mL*,20 ng/mL ,30 ng/mL*, 50 ng/mL ,0.2
ng/mg |
Features
- Fast results
- Easy visually interpretation
- Simple operation, no equipment required
- High accuracy
A rapid test for the qualitative detection of Benzodiazepines in
human urine. For medical and other professional in vitro diagnostic use only
INTENDED USE
The BZO Rapid Test Cassette (Urine) is a rapid chromatographic
immunoassay for the detection of Oxazepam (major metabolite) in urine at a cut-off concentration of
100ng/ml. This test will detect other related compounds, please refer to the Analytical Specificity table
in this package insert.
This assay provides only a qualitative, 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 Rapid Test Cassette (Urine) 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 Rapid Test Cassette (Urine)
yields a positive result when the Benzodiazepines in urine exceeds the cut-off level.
PRINCIPLE
The BZO Rapid Test Cassette (Urine) 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 the cut-off level, will not saturate the
binding sites of the antibody in the test.
The antibody coated particles will then be captured by immobilized
Benzodiazepines-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 the
cut-off level, because it will 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 less 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 contains mouse monoclonal anti-Benzodiazepines antibody
coupled particles and Benzodiazepines-protein conjugate. A goat antibody is employed in
the control line system.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or
refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The
test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration
date.
DIRECTIONS FOR USE
Allow the test, urine specimen, and/or controls to reach room
temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove
the test cassette from the sealed pouch and use it within one hour.
2. Place the test device on a clean and level surface. Hold the
dropper vertically and transfer 3 full drops of urine (approx. 120 uL) to the specimen well (S) of the
test cassette, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the
illustration below.
3. Wait for the colored line(s) to appear. Read results at 5
minutes. Do not interpret the result after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two lines appear. One colored line should be in the
control line region (C), and another apparent colored line should be in the test line region (T). This
negative result indicates that the Benzodiazepine concentration is below the detectable cut-off level.
*NOTE: The shade of color in the test line region (T) may vary, but
it should be considered negative whenever there is even a faint colored line.
POSITIVE: One colored line appears in the control line region (C).
No line appears in the test line region (T). This positive result indicates that the Benzodiazepine
concentration exceeds the detectable cut-off 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. If the problem persists, discontinue using
the test kit immediately and contact your local distributor.
Order Information
| Cat. No. | Product | Specimen | Pack |
| DBZ-102 | Benzodiazepines (BZO) Rapid Test Cassette | Urine | 40T |
| DBZ-114 | Benzodiazepines (BZO) Rapid Test Panel | Urine | 40 T |
| DBZ-802 | Benzodiazepines (BZO) Rapid Test Cassette | Oral Fluid | 25 T |
| DBZ-803 | Benzodiazepines (BZO) Rapid Test Device | Oral Fluid | 25 T |
| DBZ-402 | Benzodiazepines (BZO) Rapid Test Cassette | WB/S/P | 40 T |
| DBZ-X14 | Benzodiazepines (BZO) Rapid Test Panel | Powder | 25 T |
| DBZ-H902 | Benzodiazepines (BZO) Rapid Test Cassette | Hair | 10 T |
QUALITY CONTROL
A procedural control is included in the test. A colored line
appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient
specimen volume, adequate membrane wicking and correct procedural technique.
Control standards are not supplied with this kit; however, it is
recommended that positive and negative controls be tested as good laboratory testing practice to confirm
the test procedure and to verify proper test performance.
