STORAGE & STABILITY
- The kit should be stored at 2-30°C until the expiry date printed on the sealed pounch.
- The test must remain in the sealed pouch until use.
- Do not freeze.
- Care should be taken to protect the components of the kit from contamination of dispensing equipment, containers or reagents can lead to false results.
INTENDED USE
The BUP One Step Buprenorphine Test Device (Urine) is a lateral flow chromatographic immunoassay for the detection of Buprenorphine in human urine at a cut-off concentration of 10 ng/mL.
INTRODUCTION
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 HCI. 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 Tesl Device (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 Device (Urine) yields a positive result when the Buprcnorphine in urine exceed 10 ng/mL.
