WhatsApp USA: +1 6032769350 | WhatsApp HK: +852 63697831
Global Healthcare Medical
GHM Respiratory Syncytial Virus (RSV) Antigen Rapid Test US – Qualitative Detection of RSV Nucleoprotein Antigen with 8-Minute Results, Nasal / Nasopharyngeal Swab Sample Compatibility, and Professional Point-of-Care Use
GHM Respiratory Syncytial Virus (RSV) Antigen Rapid Test US – Qualitative Detection of RSV Nucleoprotein Antigen with 8-Minute Results, Nasal / Nasopharyngeal Swab Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Respiratory Syncytial Virus (RSV) Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Respiratory Syncytial Virus (RSV) Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein 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 acute RSV respiratory infection in symptomatic individuals.
Respiratory syncytial virus (RSV) is a highly contagious, enveloped RNA virus belonging to the Pneumoviridae family. RSV is a leading cause of acute lower respiratory tract infection (ALRI) worldwide, particularly in infants, young children, and older adults. In 2019, an estimated 33 million cases of ALRI due to RSV occurred in children younger than 5 years, leading to over 66,000 in-hospital deaths. In the same year, RSV affected approximately 5.2 million adults aged 60 years and older. Notably, 55% of RSV-associated hospitalizations and 61% of RSV-associated ICU admissions occurred in infants under 1 year of age, while 83% of RSV-associated deaths occurred in the ≥65 years age group. Among adults aged 60 and older, 30-day mortality rates associated with RSV hospitalization reached 14.7%, exceeding those of influenza.
RSV infection can present with symptoms ranging from mild upper respiratory illness to severe bronchiolitis and pneumonia. Because clinical symptoms of RSV overlap with those of influenza, COVID-19, and other respiratory viruses, rapid and accurate differential diagnosis is essential for appropriate clinical management, infection control, and timely therapeutic intervention. Rapid antigen detection tests (RADTs) provide faster turnaround times and greater accessibility than molecular assays, making them practical tools for the early diagnosis of respiratory infections.
The GHM RSV 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, 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 RSV 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 the RSV nucleoprotein antigen, 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. If RSV nucleoprotein antigens are present, they will bind to the colloidal gold particles coupled with monoclonal antibodies specifically targeting the RSV nucleoprotein antigen, producing a visible colored line at the test region.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Double antibody sandwich method | Targeted detection of RSV nucleoprotein antigen |
| RSV-specific monoclonal antibodies | Specific and accurate detection |
| Qualitative visual result | Clear and interpretable test outcome |
| No special equipment required | Simple and efficient testing workflow |
Fast Results – 8 Minutes
The GHM RSV 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. Rapid antigen diagnostic tests can rapidly detect respiratory pathogens, allowing for the prompt initiation of infection control measures and the prevention of nosocomial spread within hospital 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 RSV 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. Nasopharyngeal and nasal swabs are both acceptable specimen types for RSV antigen detection. The test is optimized for early-stage infection detection, with the highest sensitivity within the first few days 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 RSV Respiratory Infection
The GHM RSV Antigen Rapid Test US is intended for use as an aid in the diagnosis of acute RSV respiratory infection. Antigen testing is most effective when performed within the first few days of symptom onset, when viral loads are typically highest. The test provides rapid etiological diagnosis, enabling timely clinical decision-making and supporting infection control measures.
The test is particularly valuable for pediatric and geriatric patient populations, where RSV infections are more prevalent and can be clinically severe. Rapid identification of RSV infection supports appropriate patient management, reduces unnecessary antibiotic use, and helps limit hospitalizations. In emergency department settings, point-of-care testing facilitates decision-making concerning patient isolation, possible antiviral treatment initiation, and infection control, with studies demonstrating that rapid antigen detection can reduce antibiotic prescriptions in pediatric emergency settings.
| Feature | Benefit |
|---|---|
| Active infection detection aid | Supports identification of current RSV infection |
| Early symptomatic phase utility | Optimized for the acute phase of respiratory infection |
| Differential diagnosis support | Helps distinguish RSV from influenza, COVID-19, and other viral causes |
| Pediatric relevance | Particularly useful in pediatric clinical settings |
| Geriatric relevance | Valuable for older adult patient populations |
| 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 RSV Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. The test is calibrated to perform optimally in samples with high viral loads, where antigen rapid tests achieve their highest sensitivity. Clinical evaluations of rapid antigen tests for RSV have demonstrated strong performance, making them valuable tools for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 95.7% |
| Specificity | 99.1% |
| 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 RSV 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 Respiratory Syncytial Virus (RSV) Antigen Rapid Test US |
| Product Code | RSV-502b |
| Product Type | Respiratory Syncytial Virus (RSV) Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of RSV nucleoprotein antigen directly from human nasal or nasopharyngeal swab specimens; used as an aid in the diagnosis of acute RSV respiratory infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold double antibody sandwich immunoassay |
| Target Antigen | RSV nucleoprotein antigen |
| Specimen | Nasal swab / Nasopharyngeal swab |
| Time to Result | 8 minutes |
| Sensitivity | 95.7% |
| Specificity | 99.1% |
| 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 | RSV Rapid Antigen Test Cassette, Extraction Buffer, Sterile Swabs, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM RSV 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 |
| RSV nucleoprotein-specific detection | Targeted detection of RSV antigen |
| High sensitivity and specificity | 95.7% sensitivity and 99.1% specificity |
| Pediatric relevance | Particularly valuable in pediatric clinical settings |
| Geriatric relevance | Valuable for older adult patient populations |
| Infection control support | Enables prompt isolation and cohorting decisions |
| 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 Respiratory Syncytial Virus (RSV) 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.
