CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
October 2017—Beckman Coulter Diagnostics and partner Diazyme Laboratories announced FDA clearance of a new procalcitonin (PCT) assay for the management of bacterial infections and sepsis.
This assay is the first homogenous PCT assay for use on Beckman Coulter AU analyzers, models 480, 680, and 5800. The assay features a latex-enhanced immunoturbidimetric methodology, which uses multiple monoclonal antibodies for enhanced assay sensitivity and specificity.
Beckman Coulter has partnered with Diazyme, a cGMP and ISO 13485 certified medical device manufacturer, to distribute the PCT assay.
Beckman Coulter Diagnostics, 714-993-5321