# US 2013/0239647 A1 · Method and System to Amplify and Measure Breath Analytes

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- Number: US 2013/0239647 A1
- Document ID: US20130239647A1
- Status: Published application
- Kind: A1
- Application number: 13/423,527
- Filed: 2012-03-19
- Published: 2013-09-19
- Earliest claimed: 2012-03-19
- Inventors: Richard C. Fuisz; Joseph M. Fuisz
- Web page: https://patentgrep.com/patent/US20130239647A1

## CPC

- A61B 5/097: Devices for facilitating collection of breath or for directing breath into or through measuring devices
- A61B 5/082: {Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath (A61B5/083, A61B5/091 take precedence)}
- G01N 33/497: of gaseous biological material, e.g. breath
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

A method of avoiding a contaminant which would skew an analyte result in a breath analysis method and of calibrating subject of the breath analysis includes, immediately before the breath analysis method or the collection of breath for the breath analysis method, administering to the subject a predetermined gas composition. A system for analyzing an analyte in breath of a subject while avoiding a local contaminant which would skew an analyte result and calibrating the subject of so that the result of the analyte analysis will be the same regardless of where the test is performed geographically, includes a source of a predetermined gas composition immediately before the breath analysis method or the collection of gas for the breath analysis method, administering to the subject a predetermined gas mixture.

## Claims

### Claim 1

A method of avoiding a contaminant which would skew an analyte result in a breath analysis method and of calibrating subject of the breath analysis comprising, immediately before the breath analysis method or the collection of breath for the breath analysis method, administering to the subject a predetermined gas composition.

### Claim 2 (depends on 1)

The method according to claim 1, wherein predetermined gas composition is a purified and standardized gas mixture.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the step of administering to the subject the predetermined gas composition comprises having the subject inhale the predetermined gas mixture from a source of the predetermined gas mixture, and exhale outside the source of the predetermined gas mixture for a predetermined period of time, in order to calibrate the subject and eliminate through washout and non repeat inhalation the majority of ambient analyte contaminants, so that analytical results can be reasonably attributed to the individual subject.

### Claim 4 (depends on 3)

The method according to claim 3, wherein the predetermined period of time is at least 350 seconds.

### Claim 5 (depends on 3)

The method according to claim 3, wherein the predetermined period of time is at least 300 seconds.

### Claim 6 (depends on 3)

The method according to claim 3, wherein the predetermined period of time is at least 250 seconds.

### Claim 7 (depends on 1)

The method according to claim 1, wherein the predetermined gas composition comprises bone dry calibration air.

### Claim 8 (depends on 7)

The method according to claim 7, wherein the predetermined gas composition further comprises a bronchodilator to augment and amplify the potential for transfer of analyte from blood to breath.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the predetermined gas composition comprises a bronchodilator to augment and amplify the potential for transfer of analyte from blood to breath and may be used in the washout and/or in the test period.

### Claim 10 (depends on 7)

The method according to claim 7, wherein the predetermined gas composition further comprises an amplification agent to facilitate the transfer of the analyte from the blood to the breath and may be used in the washout and/or in the test period.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the predetermined gas mixture comprises an amplification agent to facilitate the transfer of the analyte from the blood to the breath.

### Claim 12 (depends on 1)

The method according to claim 1, further comprising conducting the breath analysis method on the subject.

### Claim 13 (depends on 12)

The method according to claim 12, further comprising, immediately after the predetermined period of time, collecting a plurality of exhaled breaths of the subject in a closed container, and conducting the breath analysis on the plurality of exhaled breaths collected in the closed container.

### Claim 14 (depends on 13)

The method according to claim 13, wherein the closed container is expandable.

### Claim 15

A system for analyzing an analyte in breath of a subject while avoiding a local contaminant which would skew an analyte result and calibrating the subject of so that the result of the analyte analysis will be the same regardless of where the test is performed geographically, comprising a source of a predetermined gas composition immediately before the breath analysis method or the collection of gas for the breath analysis method, administering to the subject a predetermined gas mixture.
