Beckman Coulter Diagnostics, Brea, Calif, along with partner Diazyme Laboratories, Poway, Calif, has announced FDA premarket notification (510(k)) clearance of a new procalcitonin (PCT) assay, an important tool for the management of bacterial infections and sepsis.
Sepsis is the leading cause of death in US hospitals, according to the Sepsis Alliance. More than 1.6 million people in the United States are diagnosed with sepsis annually.
“Fast diagnosis and treatment are critical for patients who have become septic,” says Mike Samoszuk, MD, vice president and chief medical officer at Beckman Coulter Diagnostics. “Adding PCT to our chemistry menu offers a tool for managing bacterial infections and sepsis, which should inform the course and prognosis of the disease and facilitate therapeutic decisions. This addition is a result of our commitment to providing disease-state-management solutions.”
The assay is the first homogenous PCT assay for use on current Beckman Coulter AU model chemistry analyzers. The assay features a latex-enhanced immunoturbidimetric methodology, which uses multiple monoclonal antibodies for enhanced assay sensitivity and specificity. The fully automated PCT assay is available for use with Beckman Coulter AU analyzers, models 480, 680, and 5800.
“Healthcare providers face challenges in timely diagnosis of bacterial infections and sepsis,” says Jack Zakowski, PhD, FACB, director of scientific affairs at Beckman Coulter. “Our AU analyzers are known for high performance, speed, and accuracy. Combining our chemistry systems with this PCT assay results in fast turnaround times, and enables rapid assessment of patients in these critical situations.”
Beckman Coulter has partnered with Diazyme Laboratories to distribute the PCT assay to ensure delivery of the broadest range of solutions for clinical laboratories. Diazyme Laboratories is a cGMP and ISO 13485 certified medical device manufacturer, utilizing proprietary enzyme and immunoassay technologies to develop diagnostic reagents in user-friendly formats.
For more information, visit Beckman Coulter.