MALDI Sepsityper Kit for Microbial Identification from Positive Blood Cultures

At the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Bruker Daltonics Inc. announced the introduction of the new MALDI Sepsityper™ Kit for the rapid identification of microorganisms from positive blood culture bottles, using Bruker´s industry-leading MALDI Biotyper solution. The MALDI Biotyper has obtained the IVD-CE Mark, and is currently for Research Use Only (RUO) outside of the European Union.

The MALDI Sepsityper Kit is a set of consumables that enables a rapid and easy identification workflow after the blood culture bottle has tested positive. Microbial cells are harvested from an aliquot of blood culture, are processed using the MALDI Sepsityper Kit, and are then identified by the MALDI Biotyper workflow. The identification assay from positive blood cultures is applicable to gram-negative bacteria, gram-positive bacteria, and importantly also to yeasts. Only a few minutes after taking an aliquot from the blood culture bottle, a sample can be ready for mass spectrometry-based molecular identification by the MALDI Biotyper. This workflow is recommended and optimized for blood culture bottles without any charcoal supplements, because such supplements would need to be removed first by additional sample preparation steps.

By using the new MALDI Sepsityper product in combination with the MALDI Biotyper, in approximately 70-90% of the tested positive blood culture samples, a high-confidence identification result is available much earlier than with conventional technology, typically saving one day (or more) in time-to-result (TTR) for the crucial identification step. The MALDI Sepsityper Kit and MALDI Biotyper identification rapid blood-culture-to-ID workflow did not lead to any false positives during initial testing and validation. Bruker is planning further MALDI Sepsityper Kit validation studies with an expanded number of European clinical microbiology laboratories processing blood culture samples.

Dr. Soren Schubert, Assistant Medical Director at the Max-von-Pettenkofer Institute in Munich, Germany, stated: 'We have tested the MALDI Sepsityper kit now for several months in our laboratories and we are more than pleased with the results. The kit is easy to handle, integrated with our MALDI Biotyper approach, and in most cases gives the identification from a positive blood culture significantly earlier, when previously with conventional techniques, we only had the Gram status and the morphology of the microbes. With the MALDI Sepsityper we can expand the advantages of the MALDI Biotyper to yet another very important field of early microbial identification.'

Dr. Wolfgang Pusch, Vice President of Bruker Daltonics, commented: 'Recently, there have been numerous presentations by leaders in the field of microbiology at scientific symposia concerning the rapid direct identification of microbes isolated from positive blood culture bottles with the MALDI Biotyper system, demonstrating the high demand for this rapid new blood-culture-to-ID workflow. With over 150 MALDI Biotyper systems installed at customer sites, we believe that the new MALDI Sepsityper Kit has the potential to make the MALDI Biotyper even more broadly applicable and useful in clinical microbiology. The earliest possible microbial identification and faster TTR are of particular interest for blood cultures, where conventional techniques typically need at least one day longer for identification.'

The MALDI Sepsityper Kit is presently for research use only. Not for use in diagnostic procedures.