Automated Blood Culture System Speeds Detection of Bloodstream Infections

Conventional blood culture workflows can delay actionable results by critical hours, potentially worsening outcomes. A newly launched FDA-cleared system in the U.S. automates blood culture processing and shortens the time to detection by about three hours, according to clinical study data.

Waters Corporation (Milford, MA, USA) has announced that the BD BACTEC FXI Culture System has received U.S. Food and Drug Administration (FDA) 510(k) clearance and is now available to U.S. laboratories. Designed for high-throughput microbiology settings, the fully automated platform aims to improve the speed, consistency, and accuracy of bloodstream infection diagnostics while streamlining routine laboratory workflows.

The system automates vial loading, unloading, incubation, and detection alerts. It also introduces a first-of-its-kind blood culture platform feature: automated gravimetric measurement of individual vial volume, which objectively confirms the blood volume in each vial. By reducing pre-analytical variability and supporting recommended collection practices, the feature is intended to improve diagnostic consistency and confidence in results.

Clinical study data showed that the BD BACTEC FXI Culture System reduced mean time to detection by about three hours, from 20 to 17 hours, compared with the previous-generation BD BACTEC FX Blood Culture System. This 15% reduction can support earlier pathogen identification and more timely targeted antimicrobial therapy for patients with suspected bloodstream infections and sepsis. Given that sepsis mortality rises by 3.6% to 9.9% for every hour effective therapy is delayed, faster laboratory workflows are especially critical in acute care.

For capacity and scalability, the platform supports automated loading of up to 60 vials at a time and is available in 480- and 960-vial configurations. Its overall vial loading capacity is 50% higher than that of a leading competitor, helping reduce manual intervention and increase staff walk-away time. Beyond the U.S., the system was recently CE marked under the European Union’s In Vitro Diagnostic Regulation (IVDR) and licensed by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), enabling availability in Europe and Japan.

"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," said Donna M. Wolk, MHA, Ph.D., D(ABMM), Division Chief, Molecular and Microbial Diagnostics and Development, Geisinger Medical Laboratories. "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."

"Waters is proud to bring the BD BACTEC FXI Culture System to the U.S. market, delivering an important advancement in bloodstream infection diagnostics," said Jianqing Bennett, Senior Vice President, Waters Advanced Diagnostics, Waters Corporation. "This innovation reflects the scientific expertise and commitment of the Waters team to improve patient care. The system helps laboratories support earlier clinical decisions for patients with suspected sepsis and bloodstream infections when every hour matters."