Curian HpSA Clinical Trial Protocol
Bryan Schmitt, DO
Primary Investigator
Brief description of study
The objective of this clinical study protocol is to define the methods to be used to determine whether the IUO Curian HpSA assay will demonstrate substantial equivalence to the reference method with stool specimens from symptomatic patients suspected of having an H.pylori infection.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: H.pylori infection
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
- specimens from patients of any age or gender (though at IU we will only be collecting from patients 18 years of age and older)
- prospectively collected (fresh and frozen), leftover, unpreserved human stool specimens from patients suspected of having an H. pylori infection, and for whom an H.pylori stool antigen test had been ordered by a practicing physician
- standard of care testing completed on the specimen
- de-identified specimen
