Drug test BZO Rapid test strip ,4mm strip detecting Benzodiazepines in urine, Quick, Gold colloidal method

Intended Use

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 (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 One Step Benzodiazepines Test Strip (Urine) yields a positive result when the Benzodiazepines level in urine exceeds the cut-off level.

Test Principle

The BZO One Step Benzodiazepines Test Strip (Urine) is a rapid chromatographic 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 300 ng/mL, will not saturate the binding sites of antibody-coated particles in the test strip. 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 cutoff level, because it will saturate all the binding sites of anti-Benzodiazepines antibodies.

A drug-positive urine specimen will not generate a colored line in the test line region, while a drug-negative urine specimen or a specimen containing a drug in a concentration less than the cut-off will generate a colored 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.

DIRECTIONS FOR USE

1. Bring the pouch to room temperature before opening it. Remove the test strip from the sealed pouch and use it as soon as possible.
2. With arrows pointing toward the urine specimen, immerse the test strip vertically in the urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test strip when immersing the strip. See the illustration below.
3. Place the test strip on a non-absorbent flat surface, start the timer and wait for the red line(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

NEGATIVE:* A colored line appears in the Control region (C) and colored lines appears in the Test region (T). This negative result means that the concentrations in the urine sample are below the designated cut-off levels for a particular drug tested.

*NOTE: The shade of the colored lines(s) in the Test region (T) may vary. The result should be considered negative whenever there is even a faint line.

POSITIVE: A colored line appears in the Control region (C) and NO line appears in the Test region (T). The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.

INVALID: No line appears in the Control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for Control line failure. Read the directions again and repeat the test with a new test card. If the result is still invalid, contact your manufacturer.

QUALITY CONTROL

A procedural control is included in the test. A line appearing in the control 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 practice to confirm the test procedure and to verify proper test performance.

performance characteristics

Analytical Sensitivity

A drug-free urine pool was spiked with Benzodiazepines at the following concentrations: 0 ng/mL, 150 ng/mL, 225 ng/mL, 300 ng/mL, 375 ng/mL, 450 ng/mL and 600ng/mL. The result demonstrates > 99% accuracy at 50% above and 50% below the cut-off concentration. Results are presented in Table 2 below.

Table 2: Analytical Sensitivity Summary

Conclusion: As indicated in table above: all specimens with BZO concentration equal to or lower than150ng/mL show negative results, all specimens with BZO concentration of 300ng/mL are identified as “+/-”, and all specimens with BZO concentration equal to or higher than 450ng/mL showed positive results. Therefore, the cut-off concentration of the BZO One Step Benzodiazepines Test Strip (Urine) is determined to be 300ng/mL BZO.

Table 3 lists the compounds that are positively detected in urine by the BZO One Step Benzodiazepines Test Strip (Urine) at 5 minutes and the concentrations at which they are detected.

Table 3: Analytical Specificity