Thermo Scientific™ CEDIA® Buprenorphine II Assay received FDA 510(k) clearance and CE Mark
ATHENS, Greece, June 12, 2017 /PRNewswire/ -- EuroMedLab -- A new immunoassay for the specific detection of buprenorphine and its three major metabolites -- buprenorphine-β-D-glucuronide, norbuprenorphine, and norbuprenorphine-β-D-glucuronide -- has received 510(k) clearance from the U.S. Food and Drug Administration, registration in Canada, Australia, and New Zealand, as well as CE Mark and registration in various countries in the European Union.
Buprenorphine is considered a more practical, and in some cases, a more effective alternative to methadone in the treatment of opioid addiction because it can be prescribed on an outpatient basis rather than in methadone clinics. In addition, because buprenorphine only partially activates the opioid receptors, it produces a milder effect than other opiates. The CEDIA Buprenorphine II Assay also has no significant cross-reactivity to other opioids, such as morphine, making it suitable for testing the urine samples from patients on Slow-Release Oral Morphine (SROM) therapy (trade name Substitol®). The assay can accurately differentiate Buprenorphine treatment samples from SROM treatment samples.
"The CEDIA Buprenorphine II Assay is the only assay on the market that detects all three major metabolites," said John Kody, vice president and general manager, clinical diagnostics, at Thermo Fisher Scientific. "The ability to detect each of these metabolites is important because it minimizes the potential for false-negative results."
The CEDIA Buprenorphine II Assay is a no-wash (homogeneous) immunoassay that specifically detects buprenorphine and its three major metabolites, demonstrates good correlation with LC-MS/MS and has excellent specificity and sensitivity, making it an easy-to-use screening tool. The assay utilizes proprietary CEDIA technology, including a lyophilized formulation that is easily reconstituted and can run in both qualitative and semi-quantitative modes. Calibrators and controls are sold separately, and applications are available for a variety of clinical chemistry analyzers.
All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. CEDIA is a trademark of Roche Diagnostics and Substitol is a trademark of Mundipharma AG.
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