Early Adequate Sepsis Therapy by Point-of-Care blood culture Diagnostics using Ion Mobility Spectrometry
In Germany, a similar number of people die of sepsis (> 150 / day) as of heart attacks (mortality rate: 36.4%, worldwide: 33.3%), making this disease the third leading cause of death in Germany. The focus of FAST-IMS is the development of an innovative method for rapid pathogen identification in the blood of sepsis patients by headspace analysis of blood cultures using gas chromatography ion mobility spectrometry (GC-IMS). The aim of the point-of-care diagnostic system, which is to be set up, is to minimize the time for pathogen identification, thereby enabling rapid, individualized antibiotic therapy. The basis of the innovation for automated pathogen identification is the early detection of volatile metabolic products of the microorganisms (bacteria and fungi), during their growth in a standardized nutrient medium, which is inoculated with patient blood. Automated analysis of the gas phase (headspace) over the incubated blood cultures will allow much faster identification of pathogens than what can be achieved using conventional microbiological techniques. In the framework of published investigations on the differentiation and identification of human pathogenic microorganisms in complex culture media, the researchers have already been able to demonstrate the fundamental suitability of ion mobility spectrometry for these questions. The results of these basic laboratory studies suggest that reliable pathogen detection from blood cultures could be possible with appropriate analysis within a few hours of initial incubation. Within the scope of the proposed project, this time advantage will be harnessed by the development of an automated solution for pathogen identification in intensive care medicine.
The aim of the project is the development of a medical device that combines automated components for incubation, sample preparation and delivery as well as repeated headspace analysis of incubated blood cultures. By integrating an autosampler, the parallel processing of a larger number of samples in the sense of high throughput is to be made possible. A high degree of automation will contribute to the high acceptance in the often dynamic operation of intensive care units. The system to be developed will also be easily combined with conventional microbiological methods as a reference method, since the incubated blood cultures remain undamaged after completion of the analyzes. The autosampler concept is to be implemented for the first demonstrator, so that user-side suggestions for improvement can be taken into account as part of an early feasibility study. Finally, the device profile will be rounded off by the realization of a suitable automated data analysis and data analysis software, so that a use by trained personnel during routine operation in an intensive care unit is easily possible. Competent associated partners with proven expertise are ready to transfer the prototype into a certified medical device.