Studybox Research Dual Submission Studies
H. pylori Stool Antigen Test
One integrated study supporting both 510(k) clearance and CLIA waiver.
Studybox
Dual Submission Studies
Stool antigen testing detects active H. pylori infection, unlike serology, which remains positive after eradication, and the clinical study is built around that distinction. Subjects are classified as infected or not by biopsy-based methods at endoscopy or by urea breath test, and recent use of proton pump inhibitors, bismuth or antibiotics suppresses bacterial load and lowers stool antigen sensitivity, so a washout period is a standard eligibility criterion that removes a meaningful share of candidates.
A test-of-eradication claim adds a second visit several weeks after completion of therapy, which is unusual in IVD studies and introduces retention risk. Enrollment typically centers on gastroenterology and endoscopy practices with the reference method on hand, while waived-setting data for the device itself come from primary care and urgent care staff running the test on stool returned by patients.
- Analyte
- Helicobacter pylori antigen in stool
- Therapeutic area
- Gastrointestinal Health
- Specimens
- Stool
- Intended-use settings
- physician office, urgent care, hospital POC
- Operators
- Non-laboratory clinic staff in waived settings; laboratory staff for moderate-complexity claims.
- Comparator
- Typically a composite reference of biopsy-based methods (histology and rapid urease test, with or without culture) obtained at endoscopy, or urea breath test where endoscopy is not performed; the protocol defines how a subject is classified as infected.
Dual Submission specifics
What Changes for This Assay on This Pathway.
- A single study in which subjects undergoing endoscopy or breath testing provide stool that is tested by untrained operators at waived sites, with the reference obtained separately, supports both components.
- Stool is transportable, which allows the testing site and the reference site to differ, but chain of custody, storage temperature and time to testing must be documented.
- Modest prevalence in general U.S. populations means recruitment focuses on dyspepsia referrals and higher-prevalence communities; the plan for reaching positives should be explicit.
Endpoints the study must support
- Sensitivity and specificity against the composite reference for active infection, with 95% confidence intervals
- For a test-of-eradication claim, performance at a defined interval after completion of therapy against the same reference
- Invalid rate and inter-operator agreement for visually read devices in waived settings
Enrollment realities
Driven by infected subjects with an adequate reference, which depends on access to endoscopy or breath testing; medication washout exclusions and stool return compliance are predictable losses. U.S. prevalence is modest, so site selection targets referral populations.
How Studybox runs it
Pre-Qualified Sites, Embedded Coordinators.
Waiver evidence depends on genuine intended-use operators in genuine waived settings. Our network of 100+ pre-qualified urgent care, physician office, and point-of-care sites already runs IVD protocols, so operator recruitment and site activation don't start from zero. How we run dual submission studies →
Same assay, other pathways
Relevant FDA guidance
- Recommendations for Dual 510(k) and CLIA Waiver by Application Studies
- Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
- Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
- Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
FAQ
H. pylori Stool Antigen Test Study Questions.
01 Who operates the h. pylori stool antigen test in a dual submission study?
Non-laboratory clinic staff in waived settings; laboratory staff for moderate-complexity claims.
02 What is the comparator for a h. pylori stool antigen test study?
Typically a composite reference of biopsy-based methods (histology and rapid urease test, with or without culture) obtained at endoscopy, or urea breath test where endoscopy is not performed; the protocol defines how a subject is classified as infected.
03 What drives enrollment for a h. pylori stool antigen test study?
Driven by infected subjects with an adequate reference, which depends on access to endoscopy or breath testing; medication washout exclusions and stool return compliance are predictable losses. U.S. prevalence is modest, so site selection targets referral populations.
Let's talk IVD research
Planning a h. pylori stool antigen test study?
Tell us the intended use and setting. We'll come back with a site plan, operator strategy, and a realistic activation timeline for the dual submission pathway.