10ng/ml cut-off Drug Abuse Test Kit BUP (Buprenorphine) Rapid Diagnostic Test strip, Gold colloidal method

Product Name

BUP Rapid Diagnostic Test/ Buprenorphine Rapid Diagnostic Test
Specimen: Urine

Intended Use

Buprenorphine is a potent analgesic often used in the treatment of opioid addiction. The drug is sold under the trade names Subutex™, Buprenex™, Temgesic™ and Suboxone™, which contain Buprenorphine HCl alone or in combination with Naloxone HCl. Therapeutically, Buprenorphine is used as a substitution treatment for opioid addicts. Substitution treatment is a form of medical care offered to opiate addicts (primarily heroin addicts) based on a similar or identical substance to the drug normally used. In substitution therapy, Buprenorphine is as effective as Methadone but demonstrates a lower level of physical dependence. Concentrations of free Buprenorphine and Norbuprenorphine in urine may be less than 1 ng/mL after therapeutic administration, but can range up to 20 ng/mL in abuse situations. The plasma half-life of Buprenorphine is 2-4 hours. 1 While complete elimination of a single-dose of the drug can take as long as 6 days, the detection window for the parent drug in urine is thought to be approximately 3 days.
The BUP One Step Buprenorphine Test Strip (Urine) is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Buprenorphine in urine. The BUP One Step Buprenorphine Test Strip (Urine) yields a positive result when the Buprenorphine in urine exceeds 10 ng/mL.

Test Principle

The BUP One Step Buprenorphine Test Strip (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. Buprenorphine, if present in the urine specimen below 10 ng/mL, will not saturate the binding sites of antibody-coated particles in the test. The antibody-coated particles will then be captured by immobilized Buprenorphine 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 Buprenorphine level exceeds 10 ng/mL because it will saturate all the binding sites of anti-Buprenorphine antibodies.
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 lower 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.


DIRECTIONS FOR USE

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.
Using the provided disposable pipette, transfer 3 drops of specimen (approximately 120 µL) to the specimen well (S) of the device and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the membrane.
Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 8 minutes


INTERPRETATION OF RESULTS


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 Buprenorphine at the following concentrations: 0 ng/mL, 5ng/mL, 7.5 ng/mL, 10 ng/mL, 12.5 ng/mL and 15 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below in Table 2.

Table 2: Analytical Sensitivity Summary

Conclusion: As indicated in table above: all specimens with BUP concentration equal to or lower than 5 ng/mL show negative results, all specimens with BUP concentration of 10 ng/mL are identified as “+/-”, and all specimens with BUP concentration equal to or higher than 15ng/mL showed positive results. Therefore, the cut-off concentration of the BUP One Step Buprenorphine Test Strip (Urine) is determined to be 10ng/mL BUP.



Analytical Specificity

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

Table 3: Analytical Specificity