Benzodiazepine (BZO) Rapid Test Kit Drug of Abuse

Benzodiazepine (BZO) Rapid Test is a rapid, screening test for the qualitative detection of Benzodiazepine (BZO)and metabolites in human urine at specified cut off levels.

For professional use only.

For in vitro diagnostic use only.

【INTENDED USE OF BENZODIAZEPINE(BZO) RAPID TEST】

Rapid Benzodiazepine (BZO) Test is an immuno-chromatographic assay for the qualitative determination of the presence of Benzodiazepine (BZO) listed in the table below.

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to Benzodiazepine (BZO) of abuse test result, particularly when preliminary positive results are indicated.

【SUMMARY】

Benzodiazepine are a class of drugs that are often therapeutically used as anxiolytics, anti-convulsants and sedative hypnotics. Benzodiazepine manifest their presence by analgesia, drowsiness, confusion, diminished reflexes, lowering of body temperature, respiratory depression, blockade of adrenocortical response, and a decrease in peripheral resistance without an impact on the cardiac index. The major pathways of elimination are the kidneys (urine) and the liver where it is conjugated to glucuronic acid. Large doses of Benzodiazepine could develop tolerances and physiological dependency and lead to its abuse. Only trace amounts (less than 1%) of Benzodiazepinesare excreted unaltered in the urine, most of Benzodiazepinesin urine is conjugated drug. Oxazepam, a common metabolite of many benzodiazepine, remains detectable in urine for up to one week, which makes Oxazepam a useful marker of Benzodiazepinesabuse.

【PRINCIPLE OF BENZODIAZEPINE(BZO) RAPID TEST】

Benzodiazepine (BZO) Rapid Test is a competitive immunoassay that is used to screen for the presence of Benzodiazepine (BZO) and metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.

When the test is activated, the urine is absorbed into test by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test . This produces a colored Test line in the Test Region (T) of the Test, which, regardless of its intensity, indicates a negative test result.

When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate,

preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.

To serve as a procedure control, a colored line will appear at the Control Region (C) of Test, if the test has been performed properly.

【WARNINGS AND PRECAUTIONS】

• Immunoassay for in vitro diagnostic use only.
• Do not use after expiration date.
• The test should remain in the sealed pouch until use.
• The used test should be discarded according to local regulations.

【CONTENTS】

• Drug Test.
• Desiccant
• Leaflet with instruction for use.

【STORAGE AND STABILITY】

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Keep away from direct sunlight, moisture and heat.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

【OPERATION】

1. Test must be in room temperature (15ºC to 30ºC)
2. 1. Donor collects urine specimen in a urine cup.
3. 2. Open the sealed pouch by tearing along the notch. Remove the test from the pouch and place it on a level surface.
4. 3. Hold the sample dropper vertically, and add exactly three drops of the urine specimen into the sample well.
5. 4. The result should be read at 5 minutes. Do not interpret the result after 10 minutes. See the illustration below.

【INTERPRETATION OF RESULTS】

Preliminary positive (+)

Only one colored band appears, in the control region (C). No colored band appears in the test region (T).

Negative (-)

Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

Invalid

Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.