Diagnostic method and breath testing device

• US 9,678,058 B2
• Filed: 03/14/2012
• Issued: 06/13/2017
• Est. Priority Date: 09/03/2010
• Status: Active Grant

• Current Assignee: Anastasia Rigas
• Original Assignee: Anastasia Rigas
• Inventors: Rigas, Anastasia
• Primary Examiner(s): Fitzgerald, John
• Assistant Examiner(s): Eyassu, Marrit
• Application Number:
  US13/420,321
• Publication Number:
  US 20120234076A1
• Time in Patent Office: 1,917 Days
• Field of Search: 73 233, 73 232, 73 3105, 600532, 600300, 600543
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: G01N 2800/06 Gastro-intestinal diseases
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH

Abstract

The present invention relates to a diagnostic method and breath-testing device for the diagnosis of Celiac Disease or other gastrointestinal malabsorption in adults and children, and uses a hydrogen selective sensor in the form of a ZnO nanowire-based sensor fabricated using a focused ion beam (FIB/SEM) instrument or a thin film.

Claims

1. A method of diagnosing celiac disease in a subject comprising:

providing a hand-held breath detector comprising a mouthpiece, a trap and a hydrogen selective sensor which operates at room temperature and detects a hydrogen concentration at levels as low as 10 ppm in a breath sample;

using the hand-held breath detector on a subject to detect a hydrogen concentration in a fasting breath sample of the subject, wherein the fasting breath sample of the subject is taken without requiring the subject to ingest a xylose or sorbitol carbohydrate substrate within one hour to four hours of the breath test; and

diagnosing celiac disease in the subject if the hydrogen concentration in the fasting breath sample is above a threshold concentration.

2. The method according to claim 1, wherein the sensor is a nanosensor.

3. The method according to claim 1, wherein the sensor is a film sensor.

4. The method according to claim 3, wherein the sensor is a thin film sensor.

5. The method according to claim 1, further comprising acquiring an output signal from the hydrogen selective sensor which has a characteristic indicating a detected hydrogen concentration, using a computation module to compute the detected hydrogen concentration, and displaying the results of the computation.

6. The method according to claim 1, comprising displaying a numerical result indicating a detected hydrogen concentration.

7. The method of claim 1, comprising comparing a detected hydrogen concentration to a threshold amount, and displaying whether the amount has been exceeded, or is less than the threshold.

8. The method of claim 1, comprising using a hydrogen selective sensor comprising a ZnO nanowire-based sensor.

9. The method of claim 1, further comprising using a UV light pulse to recover the detector for repeated uses.