Beckman Coulter announced its Access PCT assay has received FDA 510(k) clearance and is now available for sale in the United States. The sensitivity of the Access PCT assay helps physicians assess critically ill patients in danger of progression to severe sepsis or septic shock—with test results available in under 20 minutes.
"When it comes to sepsis, every minute counts. Bringing the Access PCT Assay into our core laboratory automated workflow makes it possible to streamline procalcitonin testing into our routine service to clinical teams," said Dr. Bernard C. Cook, Ph.D., Chemistry Division Head and Director of Automated Core Laboratory Operations at Henry Ford Hospital in Detroit, Michigan. "In addition, our early evaluations confirmed that the assay has the accuracy and low-end sensitivity needed to help clinicians determine the best treatment options for patients with sepsis and other infections."
"Procalcitonin levels in blood have been found to correlate with the severity of bacterial infections, and also with the probability of a positive blood culture, making it a clinically useful marker in the assessment of patients with possible sepsis or at risk of progressing to septic shock. The ability to rapidly diagnose suspected sepsis patients and determine care and treatment is critical, as earlier administration of appropriate antibiotics is highly correlated with increased patient survival," said Shamiram R. Feinglass, M.D., MPH, chief medical officer, Beckman Coulter.
The Access PCT assay enables healthcare providers to integrate procalcitonin testing analysis into their routine sepsis workups on core laboratory analyzers, as a primary or reflex test programmed though Beckman Coulter's REMISOL Advance middleware. Such integration simplifies laboratory workflow and optimizes institutional sepsis management protocols while reducing the operational expense of maintaining costly dedicated instrumentation.
"Laboratories count on Beckman Coulter to provide a broad menu of solutions to help treat the most prevalent and costly health conditions," said Kathleen Orland, senior vice president and general manager for Beckman Coulter's chemistry and immunoassay business. "We are proud to offer the industry's most extensive portfolio of in-vitro diagnostic solutions for sepsis identification and management across multiple disciplines, including the Early Sepsis Indicator, the only hematology-based biomarker FDA cleared specifically for augmenting the diagnosis of sepsis. In the fight against sepsis, every minute counts. Our Access PCT assay is a key component in sepsis identification and treatment, and underscores our ongoing commitment to developing the solutions physicians need to know sooner to act faster."