As a research tool, analysis of biomarkers in exhaled breath condensate continues to be refined and reshaped as new potential applications are discovered. Collection methods, analysis techniques, and biomarker targets are being combined in new and novel ways. Standardization is a key step in transitioning the field of exhaled biomarker collection analysis from the research domain into clinical practice.
The European Respiratory Society published an updated Technical Standard for Exhaled Biomarkers in Lung Disease this summer, following the original roughly ten years ago.
Interestingly, questions still persist over the proper collection parameters and analysis techniques. To a large extent, these are the same questions posed a decade ago. Much has been learned, but there is still a ways to go before strong scientific consensus emerges. Comparing studies performed by independent groups is a powerful method of developing consensus, but the decentralized nature of the breath research community inherently limits consensus-building due to differences in approach, technique, and analysis. The breath research community continues to address this organizationally; Respiratory Research, Inc. is helping address this materially.
As a commercial provider of breath collection devices, our interest is simple: serve the needs of the research community by providing the best possible product at a fair price. In the absence of a true standard, we see our role as providing a reliable and consistent product with which one can accurately compare their research to others’ performed using the same device. This, at least, represents one set of variables in a study which can be precisely controlled and compared to other results achieved, however separated they may be by geography and time. The stronger the comparisons between studies can be, the faster scientific consensus will emerge.
Our RTube Exhaled Breath Condensate Collector has not changed in 12 years, and is functionally and chemically the exact same device today as it was then. Consistency is key to producing comparable results, and we have strong quality systems in place to ensure this consistency, year after year after year. Our manufacturing is FDA registered, certified to ISO 9001:2008, and compliant with ISO 13485. It is this strength in quality manufacturing processes and design control which has enabled us to maintain such stringent reliability and consistency. Is it the optimal collection system for all protocols? Of course not. But for many, it is.
This is why the RTube is the de facto global standard for Exhaled Breath Condensate collection. Not just because it has been used over 200,000 times in studies worldwide, not just because of the extensive references in medical journal articles, and not just because we have had ZERO adverse events attributed to the use of the RTube – ever!
It is the global standard simply because it is reliably consistent.