A rapid test with CE certified​ for the qualitative detection of Benzodia/zepines in human urine. For medical and other professional in vitro diagnostic use only.

Applications:

The BZO Rapid Test (Urine) is a rapid chromatographic immunoassay for the detection of Oxazepam (major metabolite) in urine at a cut-off concentration of 300ng/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.

Description:

How to 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 cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 120μL) 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 10minutes.

DIRECTIONS FOR PANEL USE

Allow the test, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test panel from the sealed pouch and use it within one hour.

2. Remove the cap.

3. With the arrow pointing toward the urine specimen, immerse the test panel vertically in the urine specimen for at least 10 to 15 seconds. Immerse the strip to at least the level of the wavy lines, but not above the arrow on the test panel.

4. Replace the cap and place the test panel on a non-absorbent flat surface.

5. Start the timer and wait for the colored line(s) to appear.

6. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

DIRECTIONS FOR DIPSTICK USE

Allow the test, urine specimen, and/or controls to reach room temperature (15-30ºC) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test dipstick from the sealed pouch and use it within one hour.

2. With arrows pointing toward the urine specimen, immerse the test dipstick vertically in the urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the Test Dipstick when immersing the strip. See the illustration below.

3. Place the test dipstick on a non-absorbent flat surface, start the timer and 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). A negative result indicates that the Benzo/diazepines (BZO) concentration is below the detectable 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). A positive result indicates that the Benzodiaze/pines (BZO) 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 using a new test. If the problem persists, discontinue using the lot immediately and contact your local distributor.

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