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Breath Analysis with PTR-MS has been certified for clinical use

IONICON launches the BET-med, a PTR-MS inlet system for real-time breath analysis approved for clinical use.

BET-med system

Breath gas analysis is a fast growing field of research with many potential applications that are being or are still waiting to be explored. Most instruments analyze samples offline, where samples collected into bags or onto traps can suffer from partial degradation of breath metabolites or manifestation of artifacts. IONICON PTR-MS instruments offer the possibility to analyze breath directly and in real-time with many advantages: A whole breath cycle can be monitored and both the end-tidal breath and the room-air concentrations can be extracted. IONICON developed a special sampling inlet for breath analysis that is based on Buffered-End-Tidal (BET) Sampling, which extends the time for the analysis of the end-tidal breath fraction and allows for LODs in the low pptv range from a single exhalation (see Winkler et al. 2013).  This device has now been approved for clinical use.

Employing laboratory instruments in clinical research is not straight forward. In spite of the non-invasive nature of breath gas analysis, any instrument in contact with patients has to comply with the standards for medical devices with respect to safety and electromagnetic compatibility. These regulations become increasingly enforced and prevent the application of laboratory gas analyzers in a clinical setting.

BET TÜV

In order to facilitate clinical breath analysis with PTR-MS, IONICON has developed the BET-med sampler in compliance with medical regulations (ISO 60601). It is based on IONICON’s patented Buffered-End-Tidal (BET) sampling technique and offers several advantages for breath analysis. In May 2013 the clinical phase has successfully been completed and the BET-med system was approved for clinical use by a notified body, TÜV Austria. It consists of a BET sampling inlet and a heating controller unit, which is electrically separated from the laboratory device, the IONICON PTR-MS. The BET inlet hose is 2 m long to place the analyzer outside the so-called patient area. This allows real-time breath analysis in a clinical setting with all of IONICON’s PTR-QMS and PTR-TOFMS series instruments.

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