iCARE H. Pylori Antigen Rapid Test Kit
H. Pylori Stool Antigen (HpSA) Rapid Test for Global Markets
JAL Medical is a leading Manufacturer, Exporter & Supplier of the iCARE H. Pylori Antigen Rapid Test Kit (Feces) from Singapore to hospitals, government health programs, NGOs, and bulk distributors worldwide. This H. pylori stool antigen (HpSA) test is a lateral flow chromatographic immunoassay that detects H. pylori antigens directly in human fecal specimens – delivering results in 15–20 minutes with 97.22% sensitivity and 98.00% specificity, without any laboratory equipment.
H. pylori (Helicobacter pylori) is the most common chronic bacterial infection globally, affecting over 4 billion people and responsible for over 90% of duodenal ulcers and 80% of gastric ulcers. It is classified as a WHO Group 1 carcinogen, directly linked to gastric cancer – making reliable, scalable H. pylori diagnostic test kits a public health priority.
Key Product Specifications – iCARE H. Pylori Stool Antigen Test Kit
| Specification | Detail |
| Product Name | iCARE H. Pylori Antigen Rapid Test (Feces) |
| Brand | iCARE ADVANCED |
| Detection Target | H. pylori antigen in human fecal specimen (HpSA) |
| Specimen Type | Human fecal (stool) specimen |
| Methodology | Lateral flow chromatographic immunoassay |
| Result Time | 15–20 minutes |
| Limit of Detection | 1.0 ng/mL of H. pylori lysate antigen |
| Pack Sizes | 1, 2, 5, 7, 10, 20, 25, 40 Tests/Kit |
| Storage Temperature | 2–30°C (no cold chain / no freezing required) |
| Shelf Life | 24 months from date of manufacture |
| Certification | CE marked; ISO 13485:2016; GMP certified |
Clinical Performance: Validated Accuracy of iCARE H. Pylori Antigen Rapid Test
The iCARE H. Pylori Antigen Rapid Test was evaluated against a commercial urea breath test (UBT) reference – the gold-standard non-invasive H. pylori test – using 309 fecal specimens from symptomatic patients and healthy individuals.
| Performance Metric | Result |
| Sensitivity (Positive Percent Agreement) | 97.22% (95% CI: 92.15%–99.05%) |
| Specificity (Negative Percent Agreement) | 98.00% (95% CI: 95.00%–99.22%) |
| Overall Accuracy | 97.73% (95% CI: 95.40%–98.90%) |
| Limit of Detection (LoD) | 1.0 ng/mL H. pylori lysate antigen |
| Cross-Reactivity | None with E. coli, Salmonella spp., Rotavirus, Adenovirus, Neisseria, Klebsiella (19 organisms tested) |
Step-by-Step Protocol: How to Use the H. Pylori Stool Antigen Test Kit
- Equilibrate test device, specimen collection tube, and extracted sample to room temperature (15–30°C).
- Collect a random fecal sample; stab the collection stick into the specimen at ≥5 different sites (do not scoop).
- Screw the stick into the tube and shake vigorously to extract H. pylori antigens into the buffer solution.
- Remove test device from the sealed foil pouch; place on a dry, clean, level surface; label with patient ID.
- Add 2 drops (70–90 µL) of extracted specimen into the specimen well (S). Start the timer immediately.
- Read results at 15–20 minutes: Two lines (C + T) = Positive; C line only = Negative; No C line = Invalid.
Key Advantages for Bulk Procurement: Why Choose iCARE H. Pylori Test Kits
- HpSA – Active Infection Detection: Detects current H. pylori infection, unlike serology which cannot confirm eradication
- Post-Treatment Eradication Confirmation: Clinically validated for confirming H. pylori eradication after antibiotic therapy
- No Endoscopy or Lab Equipment: Fully self-contained – suitable for primary care, rural clinics, and community screening
- Guideline-Recommended Method: Stool antigen test endorsed by European Helicobacter Study Group Maastricht Consensus
- Antimicrobial Stewardship: Confirms eradication, reducing unnecessary antibiotic re-prescription and resistance risk
- No Cold Chain: Stable at 2–30°C – easily shipped to tropical destinations in Africa, Asia, and the Caribbean
- Flexible Pack Sizes: 1–40 Tests/Kit supports from pilot validation to large-scale national program supply
Who Buys H. Pylori Rapid Test Kits in Bulk from JAL Medical?
- Government Gastric Cancer Prevention Programs in high-burden countries
- Hospital Gastroenterology Departments requiring efficient outpatient H. pylori testing
- Primary Health Care Centers and Rural Clinics without laboratory infrastructure
- International NGOs and Humanitarian Health Programs in underserved populations
- Military and Defence Medical Corps requiring portable field diagnostics
- National Antimicrobial Stewardship Programs monitoring eradication outcomes
- Bulk Distributors and Diagnostic Dealers importing IVD kits for re-distribution
Frequently Asked Questions – H. Pylori Antigen Test Kit
What is the key difference between H. pylori stool antigen test and a blood antibody test?
The stool antigen test (HpSA) detects active H. pylori infection by identifying bacterial antigens shed in feces. Blood antibody (serology) tests cannot distinguish between current and past infection - antibodies persist long after eradication. The HpSA test is therefore preferred for both initial diagnosis AND post-treatment eradication confirmation.
Can this test confirm H. pylori eradication after antibiotic treatment?
Yes. Testing should be performed at least 4 weeks after completing antibiotic therapy and 2 weeks after stopping proton pump inhibitors (PPIs) to ensure accurate eradication confirmation results.
What is the sensitivity and specificity against the gold-standard UBT reference?
The iCARE H. Pylori Antigen Rapid Test achieves 97.22% sensitivity and 98.00% specificity when compared to a commercial urea breath test (UBT) reference assay using 309 fecal specimens.
What certifications and regulatory documents does JAL Medical provide?
JAL Medical supplies CE certificates, ISO 13485:2016 certification, GMP documentation, IFUs in multiple languages, and clinical performance data to support regulatory submissions in all buyer countries.
What is the minimum order quantity (MOQ) for bulk procurement?
Pack sizes range from 1 to 40 Tests/Kit. MOQs vary by country and buyer type. Contact JAL Medical at www.jalmedical.com for country-specific pricing and bulk purchase terms.
Is this test approved for use in pediatric patients?
The test is validated for H. pylori antigen detection in human fecal specimens. Pediatric application should follow institutional gastroenterology protocols. Contact JAL Medical for specific regulatory status in your country.
How does JAL Medical support large government or NGO procurement tenders?
JAL Medical provides full tender documentation packages including WHO-compliant performance data, CE and ISO certificates, regulatory dossiers, and OEM/co-branded product options for tender compliance. The company has extensive experience supplying to government health ministries and international organizations across 57+ countries.
