The Bruker Daltonics MALDI Biotyper workflow for microbial identification in clinical microbiology has successfully obtained an IVD-CE mark with a Declaration of Conformity in accordance with the EU In Vitro Diagnostic Directive 98/79/EC.

At ECCMID 2008, Bruker Daltonik GmbH in Bremen, Germany had already announced the adaptation of its quality management system according to the ISO 13485 standard for the design, development, manufacturing, sales, distribution, installation and service of instruments and systems for in vitro diagnostic use.

In recent months, Bruker has organized and conducted extensive successful performance evaluation studies on the MALDI Biotyper workflow at several renowned centers for clinical microbiology. One clinical studies partner was Laboratory Limbach in Heidelberg, Germany which is the headquarters of a network of more than 25 associated private clinical laboratories in Germany. Another clinical studies partner was the Max von Pettenkofer-Institute in Munich, Germany.

During these clinical studies the overall identification accuracies for several microbial groups have been confirmed. Additionally, a stress test demonstrated the broad applicability of the MALDI Biotyper approach over a wide range of different microorganisms. The stress test also demonstrated that the MALDI Biotyper workflow can be applied on all linear-only Bruker MALDI-TOF mass spectrometers under IVD-CE, i.e. the microflex™ benchtop instrument, as well as the floor-standing, high-throughput autoflex™. Outside of the European Union, the MALDI Biotyper workflow is presently for research use only.

After obtaining the European Union IVD-CE label, the MALDI Biotyper is now ready to further penetrate clinical routine analysis markets for the reliable, fast and cost-effective identification of a very broad range of different micro-organisms, such as non-fermenting gram-negative bacteria, Enterobacteriaceae, other Gram-negative bacteria, Gram-positive bacteria, and 5) yeasts.

Dr. Ulrich Eigner, Head of Molecular Studies at Laboratory Limbach, commented: “The MALDI Biotyper is a promising new molecular approach for microbial identification. The speed of identification is impressive, thus significantly decreasing the turnaround times in our laboratory.”

Dr. Sören Schubert from the Max von Pettenkofer-Institute added: “As the MALDI Biotyper is using a molecular approach based on a mass spectrometric protein fingerprint, it has the potential to overcome many current problems in clinical microbiology. For example, the previously problematic analysis of so-called non-fermenting bacteria is of significant clinical relevance for samples from patients suffering cystic fibrosis.”

Dr. Guido Mix, the Bruker Daltonics Director of MALDI Biotyper Business Development concluded: “We are very pleased that our MALDI Biotyper workflow met and even exceeded the validation criteria of these clinical studies. This further confirms the very positive feedback from our European customers since the market introduction of the MALDI Biotyper. We believe that the MALDI Biotyper has the potential to rapidly become the new ‘gold standard´ in microorganism identification in clinical microbiology.”