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US 2014/0276172 A1Published application
Single-point gastric emptying breath tests
AssigneeAdvanced Breath Diagnostics, LLC
InventorKerry C. Bush
Life of this patent
Estimating the term…
Abstract
A gastric emptying breath test method that includes collecting a breath sample of the subject at only a single time point after the subject consumes the breath test meal, wherein the single time point is a time point selected from within an identified time window.
Claims37
A breath test method for diagnosing delayed gastric emptying, comprising:
- supplying a subject with a breath test meal having a 13C label;
- collecting a breath sample of the subject at only a single time point after the subject consumes the breath test meal, wherein the single time point is a time point selected from within the time window of between about 90 minutes and about 150 minutes;
- generating a gastric emptying measurement from the breath sample;
- and
- using said measurement to provide a test result.
2 more elements
A breath test method for diagnosing rapid gastric emptying, comprising:
- supplying a subject with a breath test meal having a 13C label;
- collecting a breath sample of the subject at only a single time point after the subject consumes the breath test meal, wherein the single time point is a time point selected from within the time window of between about 30 minutes and about 90 minutes;
- generating a gastric emptying measurement from the breath sample;
- and
- using said measurement to provide a test result.
2 more elements
A gastric emptying breath test method, comprising:
- supplying a subject with a breath test meal having a 13C label;
- collecting a breath sample of the subject at only a single time point after the subject consumes the breath test meal, wherein the single time point is a time point has been previously validated as showing a selected measurement difference between breath test measurements for normal subjects and breath test measurements for abnormal subjects;
- generating a gastric emptying measurement from the breath sample;
- and
- using said measurement to provide a test result.
2 more elements
A gastric emptying breath test method, comprising:
- supplying a subject with a breath test meal;
- collecting a breath sample of the subject at only a single time point after the subject consumes the breath test meal;
- and
- generating a breath test result from the breath sample;
- wherein the single time point is a time point that meets at least one of the following criteria (a) through (e):
- (a) the diagnostic sensitivity of the breath test method at the single time point is at least 75% as compared to a scintigraphy method when using the same breath test meal for both test methods;
- (b) the diagnostic specificity of the breath test method at the single time point is at least 75% as compared to a scintigraphy method when using the same breath test meal for both test methods;
- (c) the overall diagnostic concordance of the breath test method at the single time point is at least 75% as compared to a scintigraphy method when using the same breath test meal for both test methods;
- (d) the Positive Predictive Value (PPV) of the breath test method at the single time point is at least 75% as compared to a scintigraphy method when using the same breath test meal for both test methods;
- and
- (e) the Negative Predictive Value (NPV) of the breath test method at the single time point is at least 75% as compared to a scintigraphy method when using the same breath test meal for both test methods I.
8 more elements
A method for developing a single-point breath test, comprising:
- performing gastric emptying breath tests on a series of normal subjects to obtain breath test measurements at a series of time points;
- performing gastric emptying breath tests on a series of abnormal subjects to obtain breath test measurements at said series of time points;
- and
- selecting a single time point from said series of time points that shows a selected measurement difference between breath test measurements for normal subjects and breath test measurements for abnormal subjects.
1 more element
A method for developing a single-point breath test, comprising:
- performing gastric emptying breath tests on a series of normal subjects to obtain breath test measurements at a series of time points;
- performing gastric emptying breath tests on a series of abnormal subjects to obtain breath test measurements at said series of time points;
- selecting a single time point from said series of time points that shows any measurement different between normal subjects and abnormal subjects;
- calculating a 95% confidence interval around a mean value of the normal subjects at the selected single time point;
- calculating a 95% confidence interval around a mean value of the abnormal subjects at the selected single time point;
- and
- using the selected single time point in a single-point breath test if the 95% confidence interval around the mean value of the normal subjects does not overlap with the 95% confidence interval around the mean value of the abnormal subjects.
4 more elements
A method for selecting a time point for a single-point breath test, comprising:
- performing both a gastric emptying breath test and a scintigraphy test on a series of normal subjects to obtain both breath test measurements and scintigraphy measurements at a series of time points;
- performing both a gastric emptying breath test and a scintigraphy test on a series of abnormal subjects to obtain both breath test measurements and scintigraphy measurements at a series of time points;
- calculating a diagnostic sensitivity of the breath test measurement compared to the scintigraphy measurements at a time point from said series of time points;
- and
- selecting the time point for a single-point breath test if the time point has a diagnostic sensitivity of at least 75%.
2 more elements
A method for selecting a time point for a single-point breath test, comprising:
- performing both a gastric emptying breath test and a scintigraphy test on a series of normal subjects to obtain both breath test measurements and scintigraphy measurements at a series of time points;
- performing both a gastric emptying breath test and a scintigraphy test on a series of abnormal subjects to obtain both breath test measurements and scintigraphy measurements at a series of time points;
- calculating a diagnostic sensitivity of the breath test measurement compared to the scintigraphy measurements at a time point from said series of time points;
- and
- selecting the time point for a single-point breath test if the time point has a diagnostic specificity of at least 75%.
2 more elements
Dependencies are inferred from the claim text.