DOA BUP One Step Buprenorphine rapid Test with CE certificate urine test device

One Step Buprenorphine Test is a rapid one step test for the qualitative detection of Buprenorphine and its principal metabolites in human urine at specified cut-off level.

For in vitro diagnostic use only. For healthcare professional use only.

INTENDED USE

The One Step Buprenorphine Test is a lateral flow chromatographic immunoassay for the detection of Buprenorphine in human urine at the 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) 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.

Test must be in room temperature (15ºC to 30ºC)

Device:

• Remove a testing device from the foil pouch by tearing at the notch and place it on a level surface.
• Holding a sample dropper vertically, add exactly four drops of the urine specimen to the sample well.
• Read results at 5 minutes. Do not read after 10 minutes.

Strip:

• Remove the test strip from the sealed pouch and use it as soon as possible.
• 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.
• 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.

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. 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. Wondfo One Step Buprenorphine Test 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 One Step Buprenorphine Test yields a positive result when the Buprenorphine in urine exceed 10 ng/ml.