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Bruker Receives IVD CE Mark for MALDI Sepsityper Kit

NEW YORK (GenomeWeb) – Bruker today said that it has received the CE mark for its IVD MALDI Sepsityper kit and workflow for the rapid identification of microorganisms from positive blood cultures.

Developed for use with Bruker's IVD MALDI Biotyper, the kit is intended to simplify and speed identification of microorganisms in the blood cultures of septic patients. The firm launched the kit and workflow at the European Congress of Clinical Microbiology and Infectious Diseases, which is currently being held in Copenhagen, Denmark.

According to the company, the Sepsityper kits enable microbial ID in 30 minutes after gram staining and extraction from a positive blood culture, allowing clinicians to skip the day-long agar plate culturing step required for conventional methods. The method also saves an additional an additional 8 to 12 hours on the identification process itself compared to traditional biochemical methods, the company said.

Currently guidelines call for physicians to treat septic patients quickly with broad-spectrum antibiotics with the goal of switching to a more targeted therapy once the infecting organisms have been identified. According to Bruker, the Sepsityper can improve this process by providing more rapid microbial IDs.

"The introduction of the Bruker MALDI Sepsityper kit into our workflow has proved to be a decision that we are very pleased with, and that has resulted in clear benefits to the laboratory and our users," Cassie Pope, consultant clinical scientist at London's St. George's Hospital, said in a statement. "We implemented it for the identification of organisms in all blood cultures that have flagged as positive in the morning. This has reduced our time to identification by 24 hours ... allows us to provide a better service, and promotes timely prescription of appropriate narrow spectrum antimicrobials. 

The IVD MALDI Biotyper reference library currently covers more than 2,000 different bacteria species and roughly 200 species of yeast.