identify biologically relevant metabolites
Pharmaco-kinetic profiling made easy
Breath molecular Analysis in real time
Breath analysis offers a unique window to the human metabolism
- The fact that breath contains larger bio-molecules is well documented
- Each time we breath, several thousand molecular species that reflect our metabolism in that particular moment are exhaled
- Breath analysis is non invasive, and can be continuously collected
Yet, breath is underutilized in clinical practice
Breath chemical composition analysis is normally associated with small molecules, like Ethanol, CO2, or NO. Indeed, only a handful breath test are FDA-approved, and they rely on very volatile species:
- CO2 monitoring (capnography)
- NO monitoring for asthma therapy
- Hearts-breath test for heart transplant rejection
- Urea13C for diagnosys of helicobacter pylori infection
In contrast, there are lots of biomarkers with larger molecular masses, which can be detected in other bodily fluids.
because detecting high specificity biomarkers in breath is technically very challenging:
- Larger molecules tend to have very low vapor pressures, and their concentration in breath is very low.
- Breath is an extremely complex mixture. It carries human metabolites, but also other contaminants, including inhaled contaminants, and gut and bacterial metabolites.
In practice, this means that breath analyzers targeting large molecules require must have exceptional sensitivity and selectivity.
Identifying a bio-marker with sufficient statistical confidence requires measuring the breath composition of large populations of patients and controls. For this, high throughput and low memory effects are essential requirements.
Furthermore, confounding cross contaminants can cause poor data quality and wrong conclusions. Simplified data acquisition procedures with minimum handling is key to ensure good data quality.
Super sesi is designed to meet these requirements
- Superior sensitivity
- Highest selectivity
- Very high throughput
- Minimalist standardized procedures
Identifying a reliable biomarker is a very challenging task, especially a biomarker in breath, where metabolites are very diluted. SUPER SESI has been carefully designed to optimize the limits of detection for low volatility species.
More than 2000 species can be detected in each exhalation.
Only high resolution mass spectrometers have the capability of separating all the different species ionized.
This enables real-time detection of heavy species, with unique peak assignment capabilities.
How it works
- The patient exhales through a disposable mouth piece, a constant fraction of the flow is passed to the ionization region.
- In the ionization region, a nano-Electrospray creates the primary ions, which transfer their charge to the metabolites of interest.
- Ionized metabolites are efficiently transferred to the mass spectrometer for analysis.
- The mass spectrometer acquires several mass spectra per second. The time evolution of the signals produced by different species can then be tracked separately. This allows for the quantification of the different metabolites.
High quality data
Data has to reflect the composition of breath,
and be free of artifacts and other confounding variables.
Obtaining statistically significant data requires measuring large population samples. With SUPER SESI, the acquisition of exhalations is totally non invasive and can be completed in minutes.
With high sensitivity instrumentation, confounding variables can inadvertently sneak in our data set if the acquisition protocol involves too many steps or if samples have to be handled. This could jeopardize an entire breath biomarker discovery study.
For this reason, SUPER SESI, ionizes the breath samples right as they are produced. Exhalion measures the flows and CO2 concentrations, so that all exhalations are collected and analyzed under the same standardized conditions.
Deployability and implementation
- Focus on your research -
- Plug and breathe
- SUPER SESI requires a mass spectrometer to operate.
- Upon delivery, SUPER SESI is installed by FIT's technical service engineer.
- Training is provided onsite during the initial installation. After this, the user is ready to operate and install the equipment as required.
- FIT provides full technical support for two years.
- Implementing a breath research program made easy
- Breath analysis with SUPER SESI is non invasive*.
- SUPER SESI can be seamlessly integrated in the normal workflow of the clinical practice. Patients need to breathe into the instrument. This can normally take about 10 minutes per patient. Ideally, patients can breathe into the instrument during regular visits.
- Breath samples are not stored, so you can simply forget about sample storage and logistics.
- Data is collected, and FIT's algorithms for data post-processing allow you to differentiate potential biomarkers of disease.
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- Breath analysis can be catalogued as a Clinical Study,
A typical breath research plan is not a Clinical trial.
- Bureaucracy for SUPER SESI research can be much lighter
To further ease this step, we have prepared a guideline following the standard defined by www.clinicaltrials.gov that includes all instrument related information that is relevant to the preparation of your 'Clinical Study protocol'
- The sections of this guideline are arranged as the protocol registration data elements submitted to ClinicalTrials.gov for interventional studies (clinical trials) and observational studies. These sections are mostly adapted from 42 CFR Part 11. When applicable, each section provides useful information about the instrument and the breath test procedures.
- Each clinical study is unique, organizing a clinical study and preparing a protocol is the responsibility of the Principal Investigator**. The purpose of this guideline is to present the information of the SUPER SESI in a fashion that facilitates the preparation of your protocol.
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* Please note that SUPER SESI is not a sanitary product.
** Please note FIT cannot and does not take responsibility on the accuracy or the applicability of this guideline to any protocol of any clinical study.