Patent Application
20210318208
The present invention relates generally to analysis methods for the assessment of breath samples. More specifically, the present invention relates to analysis methods for the evaluation of breath volatile organic compounds (BVOC) within a breath sample to detect diseases related to coronavirus infection within a patient.
Acceptance of BVOC analysis as clinical screening technique has been slow to develop. This is due to a number of issues including: unsuccessful attempts to find individual or a small number of low-level volatile organic compounds detected in breath as marker compounds for individual diseases; lack of understanding of the physiological meaning of the detected volatiles; a dearth of standardized methods and comparable results among a group of laboratories; the difficulty to adapt sophisticated technology and instrumentation for widespread acceptance in clinical settings; few larger population studies having been conducted; and inability to translate the methods and technology to clinical settings.
Some success has been achieved for tuberculosis, oxidative stress, ulcers, some lung cancer, diabetes, and tracking heart transplant rejection, but success of BVOC analysis in the clinical space has largely been limited due to the above factors. Successful screening for breast cancer has been achieved with high accuracy and precision. Most research in this area is focused on disease detection with only a few BVOCs as the marker.
In accordance with the embodiments herein, a method for detection of diseases related to coronavirus infection using breath analysis is disclosed. The method described herein generally utilizes chemical analysis of low-level BVOCs from alveolar breath captured as a breath sample from a patient. The breath sample is then analyzed using a gas phase analysis methodology to generate an analysis result, such as a gas chromatographic chromatogram. A computer system is then used to develop a fingerprint pattern from the analysis result. The fingerprint pattern is then used to determine a patient status related to a specific disease related to coronavirus infection for the patient.
In the following description, for purposes of explanation and not limitation, details and descriptions are set forth in order to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced in other embodiments that depart from these details and descriptions without departing from the spirit and scope of the invention.
For the purpose of this disclosure, patient status includes diagnosis of inflammatory status, disease state, disease severity, disease progression, therapy efficacy, changes in patient status over time, and monitoring organ and tissue damage from coronavirus infection. Other patient statuses are contemplated.
For the purpose of definition, coronavirus is one or more of the viruses from the coronaviridae family of enveloped, positive-sense, single-strand RNA viruses.
In an illustrative embodiment of the invention, as summarized in
In a further embodiment, the sterile sampling vessel may contain a carbon dioxide sensor. This sensor could be used to determine when the patient has reached alveolar breath. This would ensure that the breath sample contains low-level VOCs. There are a number of commercially available BVOC collection samplers available which are suitable for the present invention. Many BVOC collection samplers contain a solid-state adsorbent or thin film adsorbent media to adsorb low-level VOCs thus ensuring capture. If a solid-state adsorbent or thin film adsorbent media is used in the breath sampler, thermal desorption or thin film adsorbent media techniques are used to release the low-level VOCs from the solid-state adsorbent prior to analysis with the gas phase analysis methodology.
In a further embodiment, the gas phase analysis methodology could be gas chromatography, mass spectrometry, or gas chromatography-mass spectrometry. Other gas phase analysis methods are contemplated.
In another embodiment, the fingerprint pattern is a spectrographic or chromatographic pattern within the analysis result that is specific to a particular disease related to coronavirus infection. The fingerprint pattern is typically a group of marker compounds between 75 and 450 unique compounds in predetermined concentrations for each specific disease related to coronavirus. It is contemplated, however, that a single or fewer than 75 marker compound(s) could be used to identify a particular disease related to coronavirus infection.
In an additional embodiment, patient status can be inflammatory status, disease state, disease severity, disease progression, efficacy of a particular therapy, changes in patient status over time, or monitoring tissue damage from coronavirus infection. Other patient statuses are contemplated.
In a further embodiment, a disease related to coronavirus infection may be severe acute respiratory syndrome, middle east respiratory syndrome, coronavirus disease 2019, or other diseases related to coronavirus infection. Additionally, organ and tissue damage related to coronavirus infections is also included.
