Clinically Validated Stool Antigen Detection — Rapid Test Kit and High-Purity IVD Raw Material Components
Helicobacter pylori infects approximately 50% of the global population and is the primary causative agent of peptic ulcer disease, chronic gastritis, and gastric adenocarcinoma. Non-invasive stool antigen testing is the recommended first-line diagnostic method — and the standard of care for post-eradication confirmation — by major GI society guidelines worldwide.
Sekbio's H. Pylori Antigen Rapid Test (Colloidal Gold) is a qualitative lateral flow immunoassay for direct detection of H. pylori antigen in human fecal samples, validated in a 373-patient clinical study against a CE-marked comparator with 94.93% sensitivity and 95.74% specificity.
The assay is built on a validated antibody pair: S05-HPAb-C03 (anti-H. pylori mouse monoclonal antibody, colloidal gold labeled) and S05-HPAg-C02 (recombinant H. pylori antigen, E. coli expressed). Both components are available as standalone catalog products for OEM and IVD assay developers.
Stool antigen testing is the non-invasive gold standard for both primary diagnosis and post-treatment confirmation, recommended by ACG, ESGE, and WHO guidelines.
H. pylori infects ~50% of the world's population. It is the primary cause of peptic ulcer disease and is classified as a Group 1 carcinogen by the WHO — directly linked to gastric adenocarcinoma and MALT lymphoma. Accurate diagnosis is the prerequisite for curative eradication therapy.
Unlike endoscopy-based biopsy tests (RUT, histology, culture), stool antigen testing requires no invasive procedure. It detects active H. pylori infection with sensitivity comparable to the urea breath test — making it the preferred method for primary care, high-volume screening, and pediatric patients.
Guidelines recommend confirming successful H. pylori eradication 4–8 weeks after completing antibiotic therapy. Stool antigen testing is the non-invasive method of choice for this confirmation step, replacing the need for repeat endoscopy in the majority of patients.
Endogenous interference testing confirmed no false-positive results from bilirubin (12 mg/dL), hemoglobin (6 mg/mL), or triglycerides (15 mg/mL) — all of which are commonly elevated in gastrointestinal disease, ensuring diagnostic reliability in the target patient population.
Sekbio supplies both S05-HPAb-C03 (anti-H. pylori labeled monoclonal antibody) and S05-HPAg-C02 (recombinant antigen) as standalone raw materials. Both components are optimized for the colloidal gold platform, at >95% purity with a 3-year shelf life — ready for direct integration into OEM assay development.
Analytical performance qualification was completed across three independent production lots (220815, 220816, 220817), demonstrating 100% batch-to-batch consistency at both weak positive and strong positive reference levels — confirming manufacturing robustness for OEM supply reliability.
Complete validation data from the CE technical file (CE-TCF-032), covering clinical study, 3-lot analytical performance, and endogenous interference testing.
Clinical specimens were collected from hospital patients aged 18–75 years. Results were compared against a CE-marked comparator product using paired chi-square 2×2 analysis (File No. CE-TCF-032-6.2). All three performance metrics fell within the pre-defined acceptance ranges.
| Performance Metric | Sekbio Result | Acceptance Range | Status |
|---|---|---|---|
| Relative Sensitivity | 94.93% | 90.0% – 97.9% | PASS |
| Relative Specificity | 95.74% | 92.3% – 97.9% | PASS |
| Overall Agreement | 95.44% | 92.8% – 97.9% | PASS |
| n = 373 fecal specimens; patients aged 18–75 years; compared to CE-marked validated comparator product. Study File: CE-TCF-032-6.2. | |||
| Sekbio Result | Comparator Positive | Comparator Negative | Total |
|---|---|---|---|
| Positive (+) | 134 | 4 | 138 |
| Negative (−) | 5 | 230 | 235 |
| Total | 139 | 234 | 373 |
| True positives: 134 · False positives: 4 · False negatives: 5 · True negatives: 230 | |||
Analytical validation was performed across three production lots (220815, 220816, 220817) per CE-TCF-032-6.1 protocol. All parameters met acceptance criteria across all lots and replicates.
| Test Parameter | Acceptance Criterion | Lot 220815 | Lot 220816 | Lot 220817 | Result |
|---|---|---|---|---|---|
| Membrane Strip Width | ≥ 2.5 mm | 3.00 mm | 3.00 mm | 3.02 mm | PASS |
| Liquid Migration Speed | ≥ 10 mm/min | 29.82 mm/min | 29.06 mm/min | 29.82 mm/min | PASS |
| Detection Limit | All positives at min. level | 12/12 Positive | 12/12 Positive | 12/12 Positive | PASS |
| Negative Conformity Rate | 20/20 negative | 20/20 | 20/20 | 20/20 | PASS |
| Positive Conformity Rate | 10/10 positive | 10/10 | 10/10 | 10/10 | PASS |
| Repeatability | No false pos./neg. (n=10) | 10/10 | 10/10 | 10/10 | PASS |
| Batch Consistency | Conformity ≥ 95% | 100% | 100% | 100% | PASS |
| Tested at negative, weak positive, and strong positive levels. Repeatability: 10 replicates per lot. Study File: CE-TCF-032-6.1. | |||||
Interference substances were tested across 3 batches × 3 samples × 3 replicates. All results were negative — confirming the test is not susceptible to clinically relevant concentrations of common endogenous interferents in GI patient samples.
| Interferent | Test Concentration | Results (all lots) | Conclusion |
|---|---|---|---|
| Bilirubin | 12 mg/dL | All negative (−) | No interference |
| Hemoglobin | 6 mg/mL | All negative (−) | No interference |
| Triglycerides | 15 mg/mL | All negative (−) | No interference |
| Each interferent tested at 3 batches × 3 samples × 3 replicates. No false positives observed in any condition. | |||
Both key biomolecular components of the H. Pylori Rapid Test assay are available as standalone catalog products — optimized for the colloidal gold platform with >95% purity and 3-year shelf life.
Both S05-HPAb-C03 and S05-HPAg-C02 should be aliquoted into single-use volumes prior to long-term storage at −20°C. Repeated freeze-thaw cycles will degrade activity and should be strictly avoided. For working stocks used regularly, maintain at 2–8°C.
Validated for clinical H. pylori diagnosis, post-eradication confirmation, point-of-care settings, and IVD manufacturer raw material supply.
For patients presenting with dyspepsia, peptic ulcer, or suspected H. pylori infection, the stool antigen test provides rapid non-invasive diagnosis from a fecal sample — avoiding the need for endoscopy in the initial diagnostic workup and enabling immediate treatment decisions.
Clinical guidelines (ACG, ESGE) recommend confirming eradication 4–8 weeks after completing antibiotic therapy. The H. Pylori Antigen Rapid Test provides a simple, accurate method for eradication confirmation in primary care, gastroenterology clinics, and community health settings.
S05-HPAb-C03 and S05-HPAg-C02 are available as OEM raw materials for colloidal gold lateral flow kit manufacturers. Both components are supplied at >95% purity, validated in a CE-registered assay, and available in bulk quantities for assay development and commercial production.
The lateral flow format requires no specialized instrumentation — results are visible to the naked eye within minutes. This makes the assay suitable for deployment in primary care clinics, community health centers, pharmacies, and low-resource settings where laboratory infrastructure is limited.
Understanding the pathogen and why stool antigen testing is the optimal non-invasive diagnostic method.
Multiple non-invasive H. pylori testing strategies exist. Stool antigen testing and the urea breath test (UBT) are the two guideline-recommended methods for both diagnosis and post-treatment confirmation, offering superior performance over serology for active infection detection.
| Test Method | Detects Active Infection | Suitable for Post-Eradication | Infrastructure Required |
|---|---|---|---|
| Stool Antigen Test (SAT) | Yes | Yes (4–8 weeks post-Rx) | None (rapid test format) |
| Urea Breath Test (UBT) | Yes | Yes | Isotope analyzer |
| Serology (IgG) | No (detects past exposure) | Not recommended | Laboratory |
| Endoscopy + RUT / Biopsy | Yes | Yes | Endoscopy suite |
| Culture | Yes (antibiotic sensitivity) | Yes | Specialized microbiology lab |
| ACG, ESGE, and Maastricht V/Florence guidelines recommend SAT or UBT as first-line non-invasive methods. SAT offers a cost and logistics advantage over UBT in primary care and POCT settings. | |||
H. pylori is the most prevalent bacterial infection globally. Its clinical significance ranges from asymptomatic carriage to life-threatening malignancy — making accurate, accessible diagnostic testing a public health priority.
| Clinical Manifestation | Estimated Prevalence in H. pylori–Infected Patients | Diagnostic Priority |
|---|---|---|
| Asymptomatic carriage | ~80% | Screening in high-risk populations |
| Chronic gastritis | Nearly universal in infected patients | Endoscopy ± SAT |
| Peptic ulcer disease | ~10–15% | SAT / UBT for confirmation |
| Gastric adenocarcinoma (attributable) | ~1–3% lifetime risk (varies by region) | Eradication as prevention |
| MALT lymphoma | <0.1% (but >90% H. pylori–associated) | SAT + endoscopy |
| WHO classifies H. pylori as a Group 1 definite carcinogen. Test-and-treat strategy is recommended in high-prevalence regions (>10% local prevalence) regardless of symptom status. | ||
Request the H. Pylori Antigen Rapid Test datasheet, antibody pair technical package, or OEM supply information from our team.