BUP Buprenorphine Rapid Test Cassette (Urine), 10 ng/mL cut-off, Drug Abuse Test Kit
| 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 |
99.10% |
| Specificity |
>99.9% |
| Accuracy |
99.60% |
| Cut-Off |
5 ng/mL,10 ng/mL*,0.2 ng/mg |
A rapid test for the qualitative detection of Buprenorphine in human urine. For medical and other professional in vitro diagnostic use only.
INTENDED USE
The BUP Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the detection of Buprenorphine in human urine at a cut-off concentration of 10 ng/mL. 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) or Liquid Chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
SUMMARY
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 Rapid Test Cassette (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 Rapid Test Cassette (Urine) yields a positive result when Buprenorphine in urine exceeds 10 ng/mL.
PRINCIPLE
The BUP 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. 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 in 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-Buprenorphine antibody-coupled particles and Buprenorphine-protein conjugate. A goat antibody is employed in the control line system.
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 cassette 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 distinct colored 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 Buprenorphine concentration is below the detectable level (10 ng/mL).
*NOTE: The shade of color in the test line region (T) will vary, but it should be considered negative whenever there is even a faint colored line.
POSITIVE: One colored line appears in the control region (C). No line appears in the test line region (T). This positive result indicates that the Buprenorphine concentration exceeds the detectable level (10 ng/mL).
INVALID: Control line (C) 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.
QUALITY CONTROL
A procedural control is included in the test. A colored 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.
Order Information
| Cat. No. |
Product |
Specimen |
Pack |
| DBU-102 |
Buprenorphine (BUP) Rapid Test Cassette |
Urine |
40T |
| DBU-114 |
Buprenorphine (BUP) Rapid Test Panel |
Urine |
40 T |
| DBU-802 |
Buprenorphine (BUP) Rapid Test Cassette |
Oral Fluid |
25 T |
| DBU-803 |
Buprenorphine (BUP) Rapid Test Device |
Oral Fluid |
25 T |
| DBU-402 |
Buprenorphine (BUP) Rapid Test Cassette |
WB/S/P |
40 T |
| DBU-101 |
Buprenorphine (BUP) Rapid Test Dipstick |
Urine |
50 T |
| DBU-X14 |
Buprenorphine (BUP) Rapid Test Panel |
Powder |
25 T |
| DBU-H902 |
Buprenorphine (BUP) Rapid Test Cassette |
Hair |
10 T |
