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Global Healthcare Medical
GHM Adenovirus Antigen Rapid Test US – Qualitative Detection of Adenovirus Antigen with 8-Minute Results, Nasal / Nasopharyngeal Swab Sample Compatibility, and Professional Point-of-Care Use
GHM Adenovirus Antigen Rapid Test US – Qualitative Detection of Adenovirus Antigen with 8-Minute Results, Nasal / Nasopharyngeal Swab Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Adenovirus Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Adenovirus Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of adenovirus antigen directly from human nasal or nasopharyngeal swab specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of adenovirus respiratory infections in symptomatic individuals.
Human adenovirus (HAdV) is a significant pathogen associated with severe acute respiratory infections, especially in children under 5 years of age. Respiratory infection is the most common human adenovirus disease, accounting for 7–8% of viral respiratory diseases in children less than 5 years. A multicenter study conducted across four hospitals from November 2022 to April 2023 found that the HAdV positivity rate among hospitalized children under 5 years was 10.9%, with the highest rate in children 49–60 months of age. In pediatric emergency settings, the introduction of rapid antigen nasopharyngeal swab testing for adenoviruses has simplified the diagnosis of adenoviral pharyngitis, enabling timely and accurate differentiation from bacterial causes. One study demonstrated that the mean duration of emergency department observation decreased from 31.4 hours to 10.4 hours following the introduction of rapid AdV antigenic swabs, and the hospital admission rate dropped from 9% to 0.8%. Adenovirus infections can produce symptoms that closely mimic influenza and COVID-19, making rapid differential diagnosis essential for appropriate clinical management and infection control.
The GHM Adenovirus Antigen Rapid Test US delivers qualitative results in just 8 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with both nasal and nasopharyngeal swab 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 pediatric clinics, physician office laboratories, urgent care centers, emergency departments, hospital laboratories, and clinical laboratories. 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 Adenovirus Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains colloidal gold-conjugated antibodies specific to adenovirus antigens, along with immobilized capture antibodies on the test line. During testing, the extracted swab 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 adenovirus antigen is present in the specimen.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Adenovirus-specific antibodies | Targeted detection of adenovirus antigen |
| Qualitative visual result | Clear and interpretable test outcome |
| No equipment required | Simple and efficient testing workflow |
Fast Results – 8 Minutes
The GHM Adenovirus Antigen Rapid Test US provides qualitative results in just 8 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings.
| Feature | Benefit |
|---|---|
| 8-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for pediatric clinics and emergency departments |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput testing environments |
Nasal / Nasopharyngeal Swab Compatibility – Flexible Sample Collection
The GHM Adenovirus Antigen Rapid Test US is compatible with both nasal and nasopharyngeal swab specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. The test is optimized for early-stage infection detection, with the highest sensitivity within the first 72 hours of symptom onset, when viral shedding is typically at its peak.
| Feature | Benefit |
|---|---|
| Nasal / nasopharyngeal swab | Flexible sample collection options |
| Simple procedure | Convenient for routine testing |
| Multiple specimen types acceptable | Adaptable to different clinical protocols |
| No special equipment required | Streamlined workflow in clinical settings |
Clinical Utility – Aid for Diagnosis of Adenovirus Respiratory Infection
The GHM Adenovirus Antigen Rapid Test US is intended for use as an aid in the diagnosis of adenovirus respiratory infections. Antigen testing is most effective when performed within the first few days of symptom onset, when viral loads are typically highest. Rapid antigen diagnostic tests can rapidly detect adenovirus, allowing for the prompt initiation of infection control measures and the prevention of nosocomial spread within hospital settings. The test is particularly valuable for pediatric and immunocompromised patient populations, where adenoviral respiratory infections are more prevalent and can be clinically severe. Early differentiation of adenoviral infection from bacterial causes supports appropriate clinical management, reduces unnecessary antibiotic use, and helps limit hospitalizations.
| Feature | Benefit |
|---|---|
| Active infection detection aid | Supports identification of current adenovirus infection |
| Early symptomatic phase utility | Optimized for the acute phase of respiratory infection |
| Differential diagnosis support | Helps distinguish adenovirus from bacterial and other viral causes |
| Pediatric relevance | Particularly useful in pediatric clinical settings |
| Infection control support | Enables prompt isolation and cohorting decisions |
| Clinical versatility | Useful across pediatric clinics, physician offices, and emergency settings |
High Accuracy – Trusted Clinical Performance
The GHM Adenovirus Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluations of rapid antigen tests for adenovirus have demonstrated strong performance, making them valuable tools for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 96.2% |
| Specificity | 98.9% |
| Accuracy | 98.2% |
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 Adenovirus 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 Adenovirus Antigen Rapid Test US |
| Product Code | ADV-502b |
| Product Type | Adenovirus Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of adenovirus antigen directly from human nasal or nasopharyngeal swab specimens; used as an aid in the diagnosis of adenovirus respiratory infections |
| Detection Principle | Lateral flow immunochromatography; colloidal gold sandwich immunoassay |
| Target Antigen | Adenovirus antigen |
| Specimen | Nasal swab / Nasopharyngeal swab |
| Time to Result | 8 minutes |
| Sensitivity | 96.2% |
| Specificity | 98.9% |
| Accuracy | 98.2% |
| Storage Temperature | 2–30°C |
| Shelf Life | 24 months |
| Application Scenario | Pediatric clinic, physician office laboratory, urgent care center, emergency department, hospital laboratory, clinical laboratory, point-of-care |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system; CE marked |
| Intended User | Professional healthcare use only |
| Kit Sizes | 1T / 5T / 25T |
| Kit Contents | Test Cassette, Extraction Buffer Tube, Disposable Swabs, Tube Holder, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Adenovirus Antigen Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 8-minute test time | Rapid turnaround for timely clinical decisions |
| Nasal / nasopharyngeal swab compatibility | Flexible and convenient sampling options |
| Adenovirus-specific detection | Targeted detection of adenovirus antigen |
| High sensitivity and specificity | 96.2% sensitivity and 98.9% specificity |
| Pediatric relevance | Particularly valuable in pediatric clinical settings |
| Differential diagnosis support | Helps distinguish adenovirus from bacterial and other viral causes |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for pediatric clinics, physician offices, and emergency departments |
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 Adenovirus 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.
