SERATEC Drug Screen BUP REF DSC-BUP A visual one-step immunoassay for the qualitative detection of Buprenorphine in human urine. For professional In Vitro

INTENDED USE The SERATEC ® Drug Screen BUP is a lateral flow, one-step immunoassay for the qualitative detection of Buprenorphine in human urine at a cut-off of 10 ng/ml. This product is used to obtain a visual, qualitative result and is intended for professional use. The assay should not be used without proper supervision and is not intended for over the counter sale to lay persons. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/ MS) has been established as the preferred confirmatory method by the National Institute of Drug Abuse (NIDA). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. BACKGROUND Buprenorphine (BUP) is available under the trade name Subutex® as tablet for the drug substitution. The active agent is already known for 30 years as pain reliever. In comparison to Methadone, Buprenorphine acts in high doses less harmful. Depending on the application form, buprenorphine is indicated for the treatment of moderate to severe chronic pain or for peri-operative analgesia. Like full agonist opiates, buprenorphine can cause drowsiness, vomiting and respiratory depression. Taking buprenorphine in conjunction with central nervous system (CNS) depressants such as sedatives, tranquilizers, alcohol, and especially benzodiazepines can be particularly dangerous. [16] Falling asleep while abusing this drug, especially while combining it with other central nervous system depressants, can be extremely dangerous and thus greatly increases the chance of serious complications or death. Buprenorphine is excreted with the urine either unchanged or after deactivation in the liver. The rate of excretion and the fraction of unchanged drug are dependent on the pH of the urine, increasing if the urine is acidic. The half-life is around 8-15 hours. The detection of Buprenorphine in the urine indicates the consumption of within the previous 2-6 days. Urine based screening tests for drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method for screening urine for drugs of abuse. The SERATEC ® Drug Screen BUP is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis of specific compounds in biological fluids. This test is a rapid, visual, competitive immunoassay that can be used for the qualitative detection of Buprenorphine in human urine at 10 ng/ml cut-off concentration.