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Global Healthcare Medical
GHM Salmonella Typhi Antigen Rapid Test US – Qualitative Detection of Salmonella typhi Antigen in Human Feces with 10-Minute Results, Professional Point-of-Care Use, and Simplified Typhoid Screening
GHM Salmonella Typhi Antigen Rapid Test US – Qualitative Detection of Salmonella typhi Antigen in Human Feces with 10-Minute Results, Professional Point-of-Care Use, and Simplified Typhoid Screening
SKU: GHM Salmonella Typhi Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Salmonella Typhi Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of Salmonella typhi antigen in human feces specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of typhoid fever caused by Salmonella typhi infection.
Typhoid fever, caused by Salmonella enterica serovar Typhi (S. Typhi), remains a significant global health burden. It is a systemic infection transmitted through the fecal-oral route, predominantly via contaminated food and water in regions with inadequate sanitation infrastructure. The disease is characterized by prolonged fever, headache, abdominal pain, and gastrointestinal symptoms that are clinically indistinguishable from other febrile illnesses. Early and accurate detection of Salmonella typhi is essential for timely initiation of appropriate antimicrobial therapy, prevention of severe complications such as intestinal perforation, and effective infection control.
Traditional diagnostic approaches such as blood culture, while considered the gold standard, require specialized laboratory infrastructure, trained personnel, and extended turnaround times of 48–72 hours. The GHM Salmonella Typhi Antigen Rapid Test US provides a practical, point-of-care alternative for the rapid detection of Salmonella typhi antigen directly from fecal specimens, delivering results in just 10 minutes. The test is designed for use in clinical settings where rapid etiological diagnosis is needed to guide timely clinical decision-making and appropriate patient management.
The GHM Salmonella Typhi Antigen Rapid Test US is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including primary care clinics, hospital laboratories, emergency departments, travel medicine clinics, and clinical laboratories in typhoid-endemic regions. 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
Colloidal Gold Immunochromatography – Reliable Qualitative Detection
The GHM Salmonella Typhi Antigen Rapid Test US is based on lateral flow immunochromatography technology, utilizing a double antibody sandwich method. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to Salmonella typhi antigen, along with immobilized capture antibodies on the test line. During testing, the extracted fecal 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 Salmonella typhi antigen is present in the specimen. A control line serves as an internal procedural control.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Double antibody sandwich principle | Targeted detection of Salmonella typhi antigen |
| S. typhi-specific monoclonal antibodies | Specific and accurate detection |
| Qualitative visual result | Clear and interpretable test outcome |
| Internal procedural control | Confirms proper test performance |
Fast Results – 10 Minutes
The GHM Salmonella Typhi 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. Rapid antigen detection enables faster case identification and supports timely initiation of appropriate clinical management.
| Feature | Benefit |
|---|---|
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for primary care clinics and emergency departments |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput screening environments |
Feces Sample Compatibility – Simple and Non-Invasive Collection
The GHM Salmonella Typhi Antigen Rapid Test US is compatible with human feces specimens, providing a simple and non-invasive sample collection method. The test uses collection tubes with extraction buffer for convenient specimen processing. Fresh stool specimens are recommended for optimal results. 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 non-invasive sample collection |
| Collection tubes with extraction buffer | Convenient specimen processing |
| No dietary restrictions required | Simplified testing protocol |
| No special equipment required | Streamlined workflow in clinical settings |
| Flexible specimen storage | Convenient handling for delayed testing |
Clinical Utility – Aid for Diagnosis of Typhoid Fever
The GHM Salmonella Typhi Antigen Rapid Test US is intended for use as an aid in the diagnosis of Salmonella typhi infection in symptomatic patients. The test provides rapid antigen detection, enabling timely clinical decision-making and supporting patient management. Early and accurate identification of typhoid fever is essential for reducing typhoid-related morbidity and mortality through prompt initiation of appropriate antimicrobial therapy.
The test is particularly valuable in settings where rapid identification of Salmonella typhi infection supports timely clinical management and infection control measures. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited. When used in conjunction with clinical assessment and other diagnostic methods, this rapid antigen test supports comprehensive evaluation of patients presenting with symptoms consistent with typhoid fever.
| Feature | Benefit |
|---|---|
| Antigen detection aid | Supports identification of Salmonella typhi antigen in fecal specimens |
| Rapid etiological diagnosis | Enables timely initiation of appropriate antimicrobial therapy |
| Screening test utility | Suitable for use as a screening test in clinical settings |
| Field-friendly testing | No instrumentation required, suitable for decentralized settings |
| Clinical versatility | Useful across primary care clinics, hospitals, and travel medicine settings |
High Specificity – Trusted Clinical Performance
The GHM Salmonella Typhi Antigen Rapid Test US is designed to deliver reliable clinical performance with high specificity. Published evaluations of rapid Salmonella typhi antigen tests have demonstrated strong performance, making this assay a valuable tool for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 86.0% (stool antigen test vs. stool culture) |
| Specificity | 95.2% (stool antigen test vs. stool culture) |
| Time to Result | 10 minutes |
| Specimen | Feces |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
Performance characteristics based on published evaluations of rapid Salmonella typhi stool antigen tests. A comparative study of stool antigen and serum antibody assays relative to stool culture among patients with suspected typhoid fever reported a sensitivity of 86.0% for the stool antigen test compared with 76.7% for the serum antibody test, with specificities of 95.2% and 90.3%, respectively. Independent evaluations of rapid antigen tests for Salmonella typhi have reported sensitivities ranging from 65.3% to 100% and specificities ranging from 82.2% to 100%, depending on the product, population, and reference method used. Detection is optimal in specimens collected during the acute phase of infection, and the test is best suited for use as an aid in the diagnosis of typhoid fever in symptomatic patients. The test provides a preliminary result; blood culture remains the gold standard for definitive diagnosis.
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 Salmonella Typhi 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 Salmonella Typhi Antigen Rapid Test US |
| Product Type | Salmonella Typhi Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of Salmonella typhi antigen in human feces specimens; used as an aid in the diagnosis of typhoid fever caused by Salmonella typhi infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold double antibody sandwich immunoassay |
| Target Antigen | Salmonella typhi antigen |
| Specimen | Feces |
| Time to Result | 10 minutes |
| Sensitivity | 86.0% (vs. stool culture) |
| Specificity | 95.2% (vs. stool culture) |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Primary care clinic, hospital laboratory, emergency department, travel medicine clinic, clinical laboratory in typhoid-endemic regions, 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; 50 tests/kit |
| Kit Contents | Test Cassette, Collection Tubes with Extraction Buffer, Disposable Droppers, Instructions for Use |
Important Testing Notes:
-
Collect a small scoop of stool (approximately 50 mg) using the provided sampler; well-formed stools are not suitable for this test.
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Fresh stool specimens are recommended for optimal results; if not tested within 6 hours, store at 2–8°C for up to 3 days.
-
Any visible colored line in the Test line (T) indicates a positive result, as intensity varies with antigen concentration.
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A negative result does not rule out Salmonella typhi infection; blood culture remains the gold standard for definitive diagnosis.
-
The test provides a preliminary result and should be interpreted in conjunction with clinical findings and other laboratory results.
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Salmonella Typhi Antigen Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Feces sample compatibility | Simple and non-invasive sample collection |
| S. typhi-specific detection | Targeted detection of Salmonella typhi antigen |
| High specificity | 95.2% specificity vs. stool culture |
| Rapid etiological diagnosis | Enables timely initiation of appropriate antimicrobial therapy |
| Field-friendly testing | No instrumentation required, suitable for decentralized settings |
| Screening test utility | Suitable for use as a screening test in clinical 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 travel medicine 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 Salmonella Typhi 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.
