The Stanbio Chemistry Procalcitonin (PCT) LiquiColor assay from EKF Diagnostics, Cardiff, UK, has received FDA premarket notification (510(k)) clearance and is validated for use on Beckman AU 480, 680, and 5800 clinical chemistry analyzers from Beckman Coulter, Brea, Calif. EKF also announced immediate availability of a user-defined application for running the 10-minute test for bacterial infection and sepsis on Beckman AU analyzers.
PCT is a widely accepted marker for use in conjunction with other tests to identify sepsis quickly and monitor progression and severity over time. The test helps to differentiate between viral and bacterial infections, enabling early administration of antimicrobial therapy. EKF’s PCT test is designed for use on an open channel of most main brand clinical chemistry analyzers, including Abbott Architect, Hitachi, and Roche Cobas systems.
“Having EKF’s PCT assay validated on Beckman AU chemistry analyzers allows us to provide a competitive alternative product for hospital labs and should open up new markets and opportunities for us to support improved and early detection of sepsis,” says Trevor McCarthy, sales manager for EKF central laboratory products in Africa, Asia Pacific, Europe, and the Middle East.
The immunoturbidimetric assay, which features the use of monoclonal antibodies coated to latex particles, can determine PCT from 20 µL of serum or plasma specimens. The reagent set requires no reagent preparation and is designed to be used on open chemistry systems. It is available in a liquid-stable format, and can remain onboard a clinical chemistry analyzer for up to 4 weeks.
For more information, visit EKF Diagnostics.