A monoclonal stool antigen assay — the same first-line diagnostic test gastroenterology departments use in clinic — packaged for at-home collection, processed in a CLIA-certified US laboratory, with a plain-language report in 5–7 days.
Four components, four steps, one clinical answer. The kit is shipped in plain packaging, returned in a prepaid mailer, and processed by a CLIA-certified US reference lab — the same regulatory standard as the assay your physician would order.
Pre-loaded with preservative buffer. Ambient-stable for 7 days post-collection. Barcode-linked to your account at the lab.
Individually packaged. Small specimen volume (~ 50 mg) — no full bowel-movement collection required.
USPS first-class postage prepaid. No pharmacy drop-off appointment, no carrier scheduling. Drop in any USPS mailbox.
Collection date, your identifier, prep-window confirmation. Pre-filled at order; you initial and date at collection.
A printed insert and an emailed PDF. PPI, antibiotic, bismuth windows printed prominently on both.
Off PPIs for at least 14 days, off antibiotics for at least 28 days, off bismuth for at least 14 days. H2 blockers do not need to pause. The prep card itemises each.
A small specimen (~ 50 mg) collected with the supplied swab and dropped into the preservative tube. The instructions card walks the collection in two paragraphs — no special diet or fasting required.
Initial and date the requisition card, seal the tube in the supplied biohazard sleeve, drop both into the prepaid mailer, drop the mailer into any USPS box. Same-day mailing is best — but the buffer is ambient-stable for 7 days.
Results in 5–7 days after the lab receives the sample. Plain-language report by email and in your account: positive or negative, with the assay's sensitivity / specificity printed on the report, and a one-page guide on what comes next either way.
Clinical guidelines from the American College of Gastroenterology, the Maastricht consensus, and Cochrane reviews list the stool antigen test as a first-line non-invasive option for active H. pylori infection. The choice is deliberate, not arbitrary.
Antigen testing identifies organisms currently present in the gastric mucosa — not historical exposure. Distinct from antibody (serology) testing, which cannot tell active from cleared infection and which the guidelines explicitly do not recommend for diagnosis.
Monoclonal stool antigen assays match urea breath testing in sensitivity and specificity — both at ≈ 95% in pooled meta-analyses. The trade-off is logistical, not clinical: breath testing requires an in-clinic device; stool antigen ships.
Endoscopic biopsy is the gold standard for tissue, but is reserved for diagnostic ambiguity or red-flag presentations. For an asymptomatic-to-mildly-symptomatic adult investigating one of the eight conditions, non-invasive testing is the appropriate first step.
Welyon's report is binary — positive or negative — with the assay's accuracy printed alongside. Both results carry clinical meaning. Below: what each establishes, and what to do next.
Within the assay's ≈ 95% accuracy, H. pylori is currently colonising your gastric mucosa. This is a clinically actionable finding: the standard gastroenterology recommendation is eradication, regardless of which symptom prompted the test.
Within the assay's ≈ 95% accuracy and the prep window you followed, H. pylori is not currently colonising your gastric mucosa at detectable levels. This narrows your investigation — it does not close it.
Substantially, yes. The Welyon kit uses a monoclonal stool antigen assay — the same diagnostic test gastroenterology departments use in clinic and the same one recommended as first-line non-invasive in the major clinical guidelines (ACG, Maastricht, NICE). The differences are logistical, not clinical: collection happens at home, the sample returns by mail, and the report is written in plain language. The lab is CLIA-certified to the same regulatory standard as a hospital reference lab.
Sometimes — and yes for HSA / FSA. The kit is HSA/FSA eligible at point of sale, and Welyon provides an itemised receipt with CPT 87338 (the antigen detection code) suitable for out-of-network reimbursement. Coverage varies by plan and state; for patients without coverage, the kit price is published upfront with no surprise billing. The kit is one-time-purchase, not a subscription.
The Welyon test kit is available in 46 US states and the District of Columbia. Direct-to-consumer diagnostic shipping is restricted in four states (New York, New Jersey, Rhode Island, Maryland) — for residents there, the kit is available through a partnering telehealth network with a clinician-issued order. There is no additional fee for that route; the workflow is otherwise identical.
* Available via partnering telehealth network — no additional fee.
No fasting, no diet. Stool antigen detection is not affected by food intake. The only prep is the medication window — PPIs for 14 days, antibiotics for 28 days, bismuth for 14 days. H2 blockers like famotidine do not need to pause.
Active H. pylori infection is a clinically meaningful finding even in asymptomatic adults. The standard gastroenterology recommendation is eradication regardless of symptom status, because the literature on gastric cancer and ulcer risk is independent of acute symptoms. Discuss with your physician. The Welyon Foundation Protocol is available regardless of which symptom — or none — prompted the test.
The unused kit has a 12-month shelf life from shipment date — printed on the box. Once collected, the buffer is ambient-stable for 7 days; we recommend same-day mailing. The lab will not process samples received outside the stability window and will issue a free replacement kit on request.
Yes — there is no per-household or per-account limit. Each kit is tied to one person at the lab via the requisition card. Bulk orders (10+) for practitioner offices are handled separately — see the practitioner page or practice@welyon.com.
Same monoclonal antigen assay used in clinical gastroenterology. Same regulatory standard (CLIA). Different logistics — at home, by mail, no clinic visit, no carrier scheduling, no subscription.
These statements have not been evaluated by the Food and Drug Administration. This test kit is a Laboratory-Developed Test (LDT) processed under CLIA in a US reference laboratory. Results are not intended to diagnose, treat, cure, or prevent any disease. A positive result is a clinical finding that should be discussed with a licensed physician before any treatment is initiated.
Commercial interest disclosure. Welyon produces this test kit, publishes the eight investigation guides referenced on this page, and operates the physician-supervised Foundation Protocol for positive-result patients who opt to engage it. The investigation guides cover the same testing options regardless of brand or vendor; the protocols described would apply equally if Welyon's products did not exist.
Editorial independence. Evidence grading across the investigation series follows a single three-tier rubric, applied identically regardless of whether the resulting investigation routes a reader toward — or away from — Welyon's testing kit or protocol.