A world leader in serving science, Thermo Scientific recently announced that they secured 510(k) clearance from the US Food and Drug Administration (FDA) and CE mark for their new CEDIA® Buprenorphine II Assay. This immunoassay detects buprenorphine and its three major metabolites - buprenorphine-β-D-glucuronide, norbuprenorphine, and norbuprenorphine-β-D-glucuronide. Buprenorphine is considered as a more practical and effective alternative to methadone in the treatment of opioid addiction.
The assay received 510(k) clearance from the U.S. FDA, registration in Canada, Australia, and New Zealand, as well as CE Mark and registration in various countries in the European Union.
This assay is intended to be used with a number of clinical chemistry analyzers in laboratories and provides a simple and rapid analytical screening procedure to detect buprenorphine and its metabolites in human urine. This no-wash (homogeneous) immunoassay demonstrates good correlation with LC-MS/MS and has excellent specificity and sensitivity, making it an easy-to-use screening tool.
The 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.
It 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. CEDIA is a trademark of Roche Diagnostics and Substitol is a trademark of Mundipharma AG.
Thermo scientific is also a leading manufacturer of drugs of abuse testing reagents, calibrators and controls such as Thermo Kit Buprenorphine TSC and Thermo Kit Buprenorphine MCC.