The BD BACTEC FXI Culture System reduces detection time for bloodstream infections by approximately three hours compared to previous models.
Waters Corp announced that the Food and Drug Administration (FDA) granted 510(k) clearance for the BD BACTEC FXI Culture System, designed to accelerate sepsis detection. This clearance allows for the commercialization of the fully automated blood culture system in the US.
The system is designed to improve the speed, consistency, and accuracy of sepsis and bloodstream infection diagnostics in microbiology laboratories. According to clinical study data cited by the company, the system reduced mean time to detection by approximately three hours, or 15%, compared with the previous-generation BD BACTEC FX Blood Culture System. Detection time was reduced from 20 hours to 17 hours.
Faster detection is intended to enable earlier pathogen identification and more timely targeted antimicrobial therapy for patients with suspected bloodstream infections and sepsis. This is critical in acute care settings, as each hour of delayed sepsis treatment increases mortality by 3.6% to 9.9%, according to the company.
“Recent evidence-based laboratory guidelines document the beneficial clinical impact of rapid laboratory results for the detection of bloodstream infections; therefore, advancing the science of automated blood culture instruments is critical to further speed results,” says Donna M Wolk, PhD, division chief, molecular and microbial diagnostics and development at Geisinger Medical Laboratories, in a release. “Reducing the time to detection for positive results is key to improving the availability of Gram stain and other tests, on which treatment decisions are based. The faster, the better.”
Reducing Pre-Analytical Variability
The BD BACTEC FXI Culture System features automated gravimetric measurement of individual blood culture vial volume. By objectively confirming blood volume in each vial, the system aims to reduce pre-analytical variability and support adherence to recommended collection practices.
“The system helps laboratories support earlier clinical decisions for patients with suspected sepsis and bloodstream infections when every hour matters,” says Jianqing Bennett, senior vice president of Waters Advanced Diagnostics at Waters Corp, in a release.
Automation for High-Throughput Laboratories
Designed for high-throughput microbiology labs, the system fully automates vial loading, unloading, incubation, and detection alerts, according to a company release. It features an automated loading capacity of up to 60 vials at a time and is available in 480- and 960-vial configurations. The system is intended to deliver scalable efficiency while reducing manual intervention and increasing staff walk-away time.
The BD BACTEC FXI Culture System was recently CE marked under the European Union In Vitro Diagnostic Regulation and licensed by the Japan Pharmaceuticals and Medical Devices Agency for availability in Europe and Japan.
Photo caption: The FDA 510(k)-cleared BD BACTEC FXI Culture System is now available to the US market.
Photo credit: Waters Corp
