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Global Healthcare Medical
GHM H. Pylori Antibody Rapid Test US – Qualitative Detection of Helicobacter pylori Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM H. Pylori Antibody Rapid Test US – Qualitative Detection of Helicobacter pylori Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM H. Pylori Antibody Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM H. Pylori Antibody Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of antibodies to Helicobacter pylori (H. pylori) in human whole blood, serum, or plasma 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, with the highest incidence rates in developing countries. 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 2015–2022, though it remains a major global public health issue. Meta-analyses show that H. pylori is present in roughly 50–60% of gastritis cases, in more than 90% of duodenal ulcers, and in 50–80% of stomach ulcers. It is also the leading infectious cause of gastric cancer, accounting for roughly 78% of cases globally.
The diagnosis of H. pylori is by urea breath test, stool antigen test, and testing of endoscopic biopsy samples. Serological antibody testing offers a convenient, non-invasive option for the diagnosis of H. pylori infection, detecting the immune response to H. pylori without the need for endoscopic biopsy or radioactive testing methods. The GHM H. Pylori Antibody Rapid Test US provides a rapid, non-invasive screening solution for the detection of H. pylori antibodies in blood, enabling timely identification of individuals who may require further diagnostic evaluation and treatment.
The GHM H. Pylori Antibody Rapid Test US delivers qualitative results in just 15 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options 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, gastroenterology 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 Blood-Based Detection – Convenient and Patient-Friendly
The GHM H. Pylori Antibody Rapid Test US utilizes blood specimens for the detection of H. pylori antibodies, providing a non-invasive and patient-friendly alternative to invasive procedures such as upper endoscopy. Serological antibody testing is a well-established non-invasive method that detects the immune response to H. pylori infection, supporting accessible screening in outpatient and primary care settings.
| Feature | Benefit |
|---|---|
| Non-invasive blood specimen | Convenient and patient-friendly sample collection |
| No endoscopy required | Avoids invasive and resource-intensive procedures |
| Simple fingerstick or venipuncture | 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 Antibody Rapid Test US is based on lateral flow immunochromatography technology. The test uses a combination of H. pylori antigen-coated particles and immobilized anti-human antibodies for the qualitative detection of antibodies against H. pylori. During testing, the specimen reacts with the H. pylori antigen-coated particles and migrates up the membrane to react with the immobilized antibodies on the membrane. A colored line is generated at the test line region if H. pylori antibodies are present in the specimen.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| H. pylori antigen-coated particles | Targeted detection of H. pylori antibodies |
| Anti-human IgG capture antibody | Specific and accurate detection |
| Qualitative visual result | Clear and interpretable test outcome |
| Internal procedural control | Confirms proper test performance |
Fast Results – 15 Minutes
The GHM H. Pylori Antibody Rapid Test US provides qualitative results in 15 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings.
| Feature | Benefit |
|---|---|
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for primary care clinics and gastroenterology clinics |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput screening environments |
Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection
The GHM H. Pylori Antibody Rapid Test US is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. The test requires only a small sample volume, making it suitable for both clinic-based and field-based testing scenarios.
| Feature | Benefit |
|---|---|
| Whole blood / serum / plasma | Flexible sample collection options |
| Fingerstick or venipuncture whole blood | Suitable for different clinical settings |
| Small sample volume required | Practical for field and decentralized testing |
| No special equipment required | Streamlined workflow in clinical settings |
Clinical Utility – Aid for Diagnosis of Helicobacter pylori Infection
The GHM H. Pylori Antibody 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 serological diagnosis, 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. Serological antibody testing is a non-invasive method that can be used as an adjunct to other diagnostic approaches, particularly in resource-limited settings where urea breath testing may be unavailable. Antibiotic therapy in combination with bismuth compounds has been shown to be effective in treating active H. pylori infection, and successful eradication is associated with clinical improvement in patients with gastrointestinal diseases.
Because antibodies may persist after infection, results should be interpreted alongside other clinical findings and patient history.
| Feature | Benefit |
|---|---|
| Antibody detection aid | Supports identification of H. pylori immune response |
| Rapid serological diagnosis | Enables timely clinical decision-making |
| Screening test utility | Suitable for use as a screening test in clinical settings |
| Adjunct diagnostic support | Complements other diagnostic approaches in resource-limited settings |
| Clinical versatility | Useful across primary care clinics, hospitals, and gastroenterology settings |
High Accuracy – Trusted Clinical Performance
The GHM H. Pylori Antibody Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluation against commercial methods has demonstrated strong performance, making this assay a valuable tool for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 97.9% |
| Specificity | 97.4% |
| Overall Agreement | 97.6% |
| Reference Method | Commercial PCR |
| Cross-reactivity | No cross-reactivity observed with Influenza A/B, RSV, Adenovirus, HIV, HCV, HBV, or Syphilis |
Performance characteristics based on evaluations of rapid H. pylori antibody tests. Published studies of rapid H. pylori antibody tests have reported sensitivities ranging from 76% to 97.9% and specificities ranging from 53.6% to 97.4%, depending on the product, population, and disease severity evaluated. The sensitivity and specificity of serological tests can vary across different geographical regions due to distinct immunogenic characteristics of H. pylori strains. 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 Antibody 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 Antibody Rapid Test US |
| Product Code | IHPB-402a |
| Product Type | H. Pylori Antibody Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of antibodies to Helicobacter pylori (H. pylori) in human whole blood, serum, or plasma 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 Antibodies | Antibodies to Helicobacter pylori (IgG, IgM, IgA) |
| Specimen | Whole Blood (venipuncture or fingerstick) / Serum / Plasma |
| Time to Result | 15 minutes (do not interpret after 30 minutes) |
| Sensitivity | 97.9% |
| Specificity | 97.4% |
| Overall Agreement | 97.6% |
| Reference Method | Commercial PCR |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Primary care clinic, hospital, digestive disease clinic, gastroenterology 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 Sizes | 25 tests/kit; 40 tests/kit |
| Kit Contents | H. Pylori Antibody Test Cassette, Sample Buffer, Disposable Droppers, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM H. Pylori Antibody Rapid Test US |
|---|---|
| Non-invasive blood-based detection | Convenient and patient-friendly sample collection |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood / serum / plasma compatibility | Flexible and convenient sampling options |
| H. pylori antigen-coated particle technology | Targeted detection of H. pylori antibodies |
| High sensitivity and specificity | 97.9% sensitivity and 97.4% specificity |
| 97.6% overall agreement | Strong concordance with commercial PCR |
| No cross-reactivity | No cross-reactivity with common respiratory and bloodborne pathogens |
| Screening test utility | Suitable for use as a screening test in clinical settings |
| Adjunct diagnostic support | Complements other diagnostic approaches in resource-limited settings |
| 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 gastroenterology settings |
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 Antibody 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.
