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Global Healthcare Medical
GHM H. Pylori Antigen Rapid Test US – Qualitative Detection of Helicobacter pylori Antigen with 10-Minute Results, Feces Sample Compatibility, and Professional Point-of-Care Use
GHM H. Pylori Antigen Rapid Test US – Qualitative Detection of Helicobacter pylori Antigen with 10-Minute Results, Feces Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM H. Pylori Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM H. Pylori Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Helicobacter pylori antigen in human feces specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of Helicobacter pylori infection.
Helicobacter pylori (H. pylori) is one of the most common chronic bacterial infections worldwide, currently estimated to affect more than 50% of the world's population. The World Health Organization (WHO) has classified H. pylori as a Group 1 carcinogen, underscoring the seriousness of the infections it causes. This bacterium is primarily responsible for various gastrointestinal disorders, including peptic ulcer disease, chronic gastritis, and is a leading candidate for the development of gastric adenocarcinoma. A systematic review of the global prevalence of H. pylori infection has shown a decrease in infection rates over time, from 53% before 1990 to 44% in more recent periods, though it remains a major global public health issue. The widespread prevalence of H. pylori can be attributed to factors such as poor hygiene, contaminated water, and socio-economic status facilitating its transmission.
The diagnosis of H. pylori is by urea breath test, stool antigen test, and testing of endoscopic biopsy samples. Stool antigen testing is a convenient, non-invasive option for the diagnosis of H. pylori infection, and both urea breath testing and stool antigen testing are preferred for initial diagnosis because they are non-invasive and have high sensitivity and specificity. The GHM H. Pylori Antigen Rapid Test US provides a rapid, non-invasive screening solution for the detection of H. pylori antigen in stool, enabling timely identification of infected individuals who may require further diagnostic evaluation and treatment.
The GHM H. Pylori Antigen Rapid Test US delivers qualitative results in 10 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with feces specimens, providing a simple and non-invasive sample collection method suitable for a wide range of clinical settings.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including primary care clinics, hospitals, digestive disease clinics, and gastrointestinal health screening programs. The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system covering in vitro diagnostic test kits and analyzers based on immunochromatography.
Key Features & Benefits
Non-Invasive Fecal Antigen Detection – Convenient and Patient-Friendly
The GHM H. Pylori Antigen Rapid Test US utilizes fecal specimens for the detection of H. pylori antigen, providing a non-invasive and patient-friendly alternative to invasive procedures such as upper endoscopy. Stool antigen testing is recommended by clinical guidelines as a preferred non-invasive method for the initial diagnosis of H. pylori infection, offering comparable diagnostic accuracy to the urea breath test.
| Feature | Benefit |
|---|---|
| Non-invasive fecal specimen | Convenient and patient-friendly sample collection |
| No endoscopy required | Avoids invasive and resource-intensive procedures |
| Simple stool collection | Easy to perform in routine clinical settings |
| Suitable for all age groups | Particularly valuable for pediatric and elderly patients |
Colloidal Gold Immunochromatography – Reliable Qualitative Detection
The GHM H. Pylori Antigen Rapid Test US is based on colloidal gold immunochromatography technology. The test uses a unique combination of colloidal gold conjugate and solid-phase monoclonal antibodies to selectively identify H. pylori antigen in feces specimens. During testing, the extracted specimen reacts with the antibody-coated particles and migrates up the membrane to react with the antibodies on the membrane. A colored line is generated at the test line region if H. pylori antigen is present in the specimen.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Monoclonal antibody technology | High specificity for H. pylori antigen |
| Qualitative visual result | Clear and interpretable test outcome |
| Internal procedural control | Confirms proper test performance |
| Simple extraction procedure | Easy to perform with provided collection tubes |
Fast Results – 10 Minutes
The GHM H. Pylori Antigen Rapid Test US provides qualitative results in just 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings.
| Feature | Benefit |
|---|---|
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for primary care clinics and digestive disease clinics |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput screening environments |
Feces Sample Compatibility – Simple and Efficient Collection
The GHM H. Pylori Antigen Rapid Test US is compatible with feces specimens, providing a simple and efficient sample collection method. The test uses collection tubes with extraction buffer for convenient specimen processing. Both solid and watery fecal specimens are acceptable; follow collection protocols strictly to avoid invalid results. Collected specimens should be tested immediately if possible; if not tested within 6 hours, store at 2–8°C for up to 3 days. For long-term storage, keep below -20°C.
| Feature | Benefit |
|---|---|
| Feces specimen | Simple and efficient sample collection |
| Collection tubes with extraction buffer | Convenient specimen processing |
| No special equipment required | Streamlined workflow in clinical settings |
| Flexible specimen handling | Convenient storage options for delayed testing |
Clinical Utility – Aid for Diagnosis of Helicobacter pylori Infection
The GHM H. Pylori Antigen Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of Helicobacter pylori infection. The test provides rapid antigen detection, enabling timely clinical decision-making and supporting patient management.
The test is particularly valuable in settings where rapid identification of H. pylori infection supports timely initiation of eradication therapy and prevention of associated complications. Both urea breath testing and stool antigen testing are preferred for the initial diagnosis of H. pylori infection because they are non-invasive and have high sensitivity and specificity. Stool antigen assays have a sensitivity and specificity similar to that of urea breath tests, particularly for initial diagnosis.
| Feature | Benefit |
|---|---|
| Active infection detection aid | Supports identification of current H. pylori infection |
| Rapid etiological diagnosis | Enables timely initiation of appropriate eradication therapy |
| Screening test utility | Suitable for use as a screening test in clinical and public health settings |
| Post-treatment monitoring support | Can be used to confirm eradication after therapy |
| Clinical versatility | Useful across primary care clinics, hospitals, and digestive disease clinics |
High Accuracy – Trusted Clinical Performance
The GHM H. Pylori Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluation has demonstrated strong performance, making this assay a valuable tool for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 98.8% |
| Specificity | 98.4% |
| Accuracy | 98.6% |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
Performance characteristics based on evaluations of rapid H. pylori stool antigen tests. Published meta-analyses of stool antigen tests have reported sensitivity of 92.19% and specificity of 92.93% for conventional SAT in adults. Independent evaluations of rapid stool antigen tests have reported positive percent agreement of 96.7% and negative percent agreement of 98.2% in comparative studies. Detection is optimal when specimens are collected and processed according to the manufacturer's instructions, and the test is best suited for use as an aid in the diagnosis of H. pylori in symptomatic patients.
ISO 13485 Certified – Quality and Safety Compliance
The VivaDiag product line is manufactured under an EN ISO 13485 certified quality management system, demonstrating compliance with stringent international standards for the design, development, manufacture, and distribution of in vitro diagnostic test kits and analyzers.
| Feature | Benefit |
|---|---|
| EN ISO 13485 certification | Quality management system compliance |
| IVD scope | Certified for in vitro diagnostic test kits |
| Quality assurance | Meets high standards of quality and safety |
| Professional-grade | Designed for healthcare professional use |
CE Marked – European Conformity
The GHM H. Pylori Antigen Rapid Test US is CE marked for professional in vitro diagnostic use, demonstrating conformity with applicable European regulatory requirements for diagnostic medical devices.
| Feature | Benefit |
|---|---|
| CE marking | Regulatory compliance for professional use |
| Professional IVD use | Designed for trained healthcare personnel |
| Quality compliance | Meets European regulatory standards |
Product Specifications
| Specification | Detail |
|---|---|
| Model / SKU | GHM H. Pylori Antigen Rapid Test US |
| Product Code | HP-602a |
| Product Type | H. Pylori Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of Helicobacter pylori antigen in human feces specimens; used as a screening test and as an aid in the diagnosis of Helicobacter pylori infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antigen | Helicobacter pylori antigen |
| Specimen | Feces |
| Time to Result | 10 minutes |
| Sensitivity | 98.8% |
| Specificity | 98.4% |
| Accuracy | 98.6% |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Primary care clinic, hospital, digestive disease clinic, gastrointestinal health screening program, point-of-care |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system; CE marked |
| Intended User | Professional healthcare use only |
| Kit Size | 25 tests/kit |
| Kit Contents | Test Cassette, Collection Tubes with Extraction Buffer, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM H. Pylori Antigen Rapid Test US |
|---|---|
| Non-invasive fecal antigen detection | Convenient and patient-friendly sample collection |
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Feces sample compatibility | Simple and efficient sample collection |
| Monoclonal antibody technology | High specificity for H. pylori antigen |
| High sensitivity and specificity | 98.8% sensitivity and 98.4% specificity |
| 98.6% overall accuracy | Strong concordance with reference methods |
| Screening test utility | Suitable for use as a screening test in clinical and public health settings |
| Post-treatment monitoring support | Can be used to confirm eradication after therapy |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for primary care clinics, hospitals, and digestive disease clinics |
About Global Healthcare Medical
Global Healthcare Medical is dedicated to connecting healthcare providers, retailers, and distributors with high-quality medical devices designed for reliable performance. The GHM H. Pylori Antigen Rapid Test US is part of our professional diagnostic line, developed to support accurate, efficient, and accessible point-of-care testing in clinical environments.
Our focus is on dependable performance, clear documentation, and responsive support for professional healthcare settings.
