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Global Healthcare Medical
GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo Rapid Test US – 9-in-1 Qualitative Detection of Nine Major Respiratory Pathogens with 8-Minute Results
GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo Rapid Test US – 9-in-1 Qualitative Detection of Nine Major Respiratory Pathogens with 8-Minute Results
SKU: GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo Rapid Test US is a professional-grade lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen, influenza A nucleoprotein antigen, influenza B nucleoprotein antigen, respiratory syncytial virus (RSV) nucleoprotein antigen, adenovirus (ADV) antigen, Mycoplasma pneumoniae (MP) antigen, human parainfluenza virus (HPIV) antigen, human metapneumovirus (HMPV) antigen, human rhinovirus (HRV) antigen, and Streptococcus pneumoniae (Spn) antigen in human nasal or nasopharyngeal swab specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of active respiratory infections in symptomatic individuals.
Acute respiratory tract infections caused by these nine pathogens often present with overlapping clinical symptoms, including fever, cough, sore throat, nasal congestion, and fatigue, making them difficult to distinguish based on clinical presentation alone. Human rhinovirus (HRV) is one of the most prevalent respiratory pathogens, detected in 25.13% of hospitalized children and adolescents with acute respiratory infections, with year-round prevalence and seasonal peaks in spring and autumn. HRV mono-infections are strongly associated with hospitalizations for acute wheezing illnesses and severe clinical outcomes, and co-infections occur in 32.00% of HRV cases. Streptococcus pneumoniae (Spn) is a leading cause of community-acquired pneumonia, otitis media, and invasive pneumococcal disease. The World Health Organization has estimated that 1.6 million people die annually from pneumococcal disease, including 0.7–1 million children under five years. Spn continues to account for the largest number of lower respiratory infection deaths globally, at 634,000 (25.3% of all LRI deaths). Human metapneumovirus (hMPV) is an emerging respiratory pathogen associated with significant morbidity, particularly among young children, older adults, and immunocompromised individuals. Human parainfluenza viruses contribute to 20–40% of pediatric lower respiratory tract infections and are a leading cause of croup and hospitalizations. Mycoplasma pneumoniae is a major cause of atypical pneumonia, and adenovirus is a significant cause of respiratory illness in both children and adults. Rapid diagnostics of these pathogens are essential not only for clinical management but also for infection control and epidemiological surveillance.
The GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo 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 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
9-in-1 Combo Detection – Nine Major Respiratory Pathogens in One Test
The GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating nine major respiratory pathogens from a single patient sample. This comprehensive detection capability helps healthcare providers rapidly identify the causative pathogen among COVID-19, influenza A, influenza B, RSV, adenovirus, Mycoplasma pneumoniae, human parainfluenza virus, human metapneumovirus, human rhinovirus, and Streptococcus pneumoniae, which present with similar symptoms, enabling timely treatment decisions and improved patient outcomes.
| Feature | Benefit |
|---|---|
| 9-in-1 combo detection | Simultaneously detects SARS-CoV-2, Flu A, Flu B, RSV, ADV, MP, HPIV, HMPV, HRV, and Spn in one test |
| Single-sample workflow | Reduces the need for multiple specimen collections |
| Differentiation capability | Distinguishes between nine major respiratory pathogens |
| HRV and Spn detection included | Addresses prevalent viral and bacterial respiratory pathogens |
| Nucleoprotein/nucleocapsid targets | Conserved viral antigens for consistent detection |
| Co-infection support | Supports detection of co-infections from a single sample |
Fast Results – 8 Minutes
The GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo 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 physician office laboratories and urgent care centers |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput testing environments |
Nasal / Nasopharyngeal Swab Compatibility – Flexible Sample Collection
The GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo 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 five to seven days of symptom onset when respiratory pathogen 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 Active Respiratory Infection Detection
The GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo Rapid Test US is intended for use as an aid in the diagnosis of active SARS-CoV-2, influenza A/B, RSV, adenovirus, Mycoplasma pneumoniae, human parainfluenza virus, human metapneumovirus, human rhinovirus, and Streptococcus pneumoniae infection. Antigen testing is most effective when performed within the first five to seven days of symptom onset, when pathogen loads are typically highest. 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.
The inclusion of human rhinovirus detection is particularly valuable for pediatric and asthmatic patient populations. HRV is the most common respiratory virus detected in children and is strongly associated with acute wheezing illnesses and asthma exacerbations. Early identification of HRV infection supports appropriate clinical management and infection control decisions. The inclusion of Streptococcus pneumoniae detection supports early identification of pneumococcal respiratory infection, which is the leading bacterial cause of community-acquired pneumonia and a major contributor to lower respiratory infection mortality worldwide. Early detection of pneumococcal infection enables timely initiation of appropriate antibiotic therapy, supports antibiotic de-escalation strategies, and helps reduce unnecessary use of broad-spectrum antibiotics. By detecting all nine pathogens in a single test, this combo supports comprehensive differential diagnosis and infection control decision-making.
| Feature | Benefit |
|---|---|
| Active infection detection aid | Supports identification of current infection |
| Early symptomatic phase utility | Optimized for the acute phase of respiratory infection |
| Differential diagnosis support | Helps distinguish COVID-19, influenza A/B, RSV, adenovirus, MP, HPIV, HMPV, HRV, and Spn |
| Pediatric relevance | HRV, HMPV, and HPIV detection particularly useful in pediatric settings |
| Atypical pneumonia assessment | Supports early identification of Mycoplasma pneumoniae infection |
| Pneumococcal infection detection | Supports early identification of Streptococcus pneumoniae respiratory infection |
| Infection control support | Enables prompt isolation and cohorting decisions |
| Clinical versatility | Useful across physician offices, urgent care, and emergency settings |
Clinical Performance – High Sensitivity and Reliable Detection
The GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo Rapid Test US is designed to deliver high sensitivity and specificity across all nine target pathogens. Clinical evaluations of combined rapid antigen tests for respiratory pathogens have demonstrated strong performance across these targets, making them valuable tools for point-of-care diagnostics when correctly used.
| Target | Sensitivity | Specificity | Accuracy |
|---|---|---|---|
| SARS-CoV-2 | 97.3% | 99.4% | 98.7% |
| Influenza A | 95.5% | 99.0% | 98.0% |
| Influenza B | 94.9% | 99.7% | 98.3% |
| RSV | 96.0% | 99.0% | 98.2% |
| Adenovirus (ADV) | 96.0% | 99.0% | 98.2% |
| Mycoplasma pneumoniae (MP) | 90.4% | 99.2% | 96.3% |
| Human Metapneumovirus (HMPV) | 96.8% | 99.0% | 98.5% |
| Human Parainfluenza Virus (HPIV) | 97.4% | 98.8% | 98.3% |
| Human Rhinovirus (HRV) | 97.5% | 99.1% | 98.7% |
| Streptococcus pneumoniae (Spn) | 96.0% | 99.8% | 99.1% |
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 SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo 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 SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo Rapid Test US |
| Product Code | RVC-5105a |
| Product Type | SARS-CoV-2 / Influenza A&B / RSV / Adenovirus / Mycoplasma pneumoniae / Human Parainfluenza Virus / Human Metapneumovirus / Human Rhinovirus / Streptococcus pneumoniae Antigen Combo Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen, influenza A nucleoprotein antigen, influenza B nucleoprotein antigen, RSV nucleoprotein antigen, adenovirus antigen, Mycoplasma pneumoniae antigen, human parainfluenza virus antigen, human metapneumovirus antigen, human rhinovirus antigen, and Streptococcus pneumoniae antigen in human nasal or nasopharyngeal swab specimens; used as an aid in the diagnosis of active respiratory infections |
| Detection Principle | Lateral flow immunochromatography; colloidal gold sandwich immunoassay |
| Target Antigens | SARS-CoV-2 nucleocapsid (N) protein; Influenza A nucleoprotein; Influenza B nucleoprotein; RSV nucleoprotein; Adenovirus antigen; Mycoplasma pneumoniae antigen; Human parainfluenza virus antigen; Human metapneumovirus antigen; Human rhinovirus antigen; Streptococcus pneumoniae antigen |
| Specimen | Nasal swab / Nasopharyngeal swab |
| Time to Result | 8 minutes |
| Storage Temperature | 2–30°C |
| Shelf Life | 24 months |
| Application Scenario | 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 | 20T / 25T |
| Kit Contents | Rapid Test Cassette, Extraction Buffer Tube, Disposable Swab, Tube Rack, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo Rapid Test US |
|---|---|
| 9-in-1 combo detection | Simultaneous detection and differentiation of nine major respiratory pathogens |
| 8-minute test time | Rapid turnaround for timely clinical decisions |
| Nasal / nasopharyngeal swab compatibility | Flexible and convenient sampling options |
| Active infection detection aid | Supports early identification of symptomatic cases |
| Differential diagnosis support | Helps distinguish COVID-19, influenza A/B, RSV, adenovirus, MP, HPIV, HMPV, HRV, and Spn |
| HRV and Spn detection | Addresses prevalent viral and bacterial respiratory pathogens |
| Pediatric relevance | HRV, HMPV, and HPIV detection particularly valuable in pediatric settings |
| High sensitivity | Reliable detection across all nine target pathogens |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for physician offices, urgent care, emergency departments, and laboratories |
| Comprehensive respiratory panel | Nine-target antigen detection supports thorough clinical assessment |
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 SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HPIV / HMPV / HRV / Spn Antigen Combo 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.
