Dr. Markus Timke studied biology at the University Bremen and got his diploma degree in 2000. He specialised in molecular ecology during his PhD at the University of Osnabrück. At the German Institute of Food Technology he focused on the implementation of molecular biological methods. He is with Bruker since 2009 and he focused on analysis of mycobacteria by MALDI-TOF MS, library extension and subtyping functions.
Introduction: Identification of bacteria, yeasts or molds is widely done by MALDI-TOF MS. The Bruker MALDI Biotyper (MBT) identification system is available as US-IVD and IVD-CE cleared versions. The food market is also a highly regulated sector. The way how to achieve notifications to introduce the MBT System as a suitable and certified identification method for the food market will be summarized.
The extension of existing certificates becomes necessary if new hardware or software developments are ready for the market. This is exemplified for a new software platform (MBT Compass HT) and a new mass spectrometer device (MBT sirius).
An additional outlook will include new research use only (RUO) applications. The negative-ion mode of the MBT sirius for measuring Lipid A / colistin resistance and the automated colony picking and MALDI target preparation device named MBT Pathfinder will be presented.
Methods: Collaborative Studies were run to assess the performances of the MALDI Biotyper as confirmation and identification method. Fifteen European collaborators participated in a Salmonella study and 14 collaborators from the United States were involved in a Cronobacter study.
Results: The MBT has been certified according to the Official Method of Analysis program (OMA) of the AOAC International and by MicroVal according to the ISO 16140-part 6 standard for the submitted applications. The extension of the certificates for MBT Compass HT and MBT sirius is pending.
Conclusion: The launch of finally developed RUO products provides new software, hardware, and/or application kits in an easy and early way to users who are interested in innovative products. The manufacturer gets valuable feedback in exchange and can decide to go for notifications more reasonably. Here, the experience in the RUO as well as the clinical settings helped to extend the MBT to another regulated market, the microbial diagnostics in the food sector.