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Global Healthcare Medical
GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HMPV / HPIV Antigen Combo Rapid Test US – 7-in-1 Qualitative Detection of SARS-CoV-2, Influenza A & B, RSV, Adenovirus, Mycoplasma pneumoniae, Human Metapneumovirus, and Human Parainfluenza Virus Antigens
GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HMPV / HPIV Antigen Combo Rapid Test US – 7-in-1 Qualitative Detection of SARS-CoV-2, Influenza A & B, RSV, Adenovirus, Mycoplasma pneumoniae, Human Metapneumovirus, and Human Parainfluenza Virus Antigens
SKU: GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HMPV / HPIV Antigen Combo Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HMPV / HPIV 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 metapneumovirus (HMPV) antigen, and human parainfluenza virus (HPIV) 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 seven 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 metapneumovirus (hMPV) is an emerging respiratory pathogen associated with significant morbidity, particularly among young children, older adults, and immunocompromised individuals. The global pooled prevalence of hMPV among patients with respiratory tract infections is 5.3%, with prevalence highest in children under 5 years at 6.7%. Among children under 5, the age group 25–36 months has the highest prevalence at 10.1%. Human parainfluenza viruses contribute to 20–40% of pediatric lower respiratory tract infections and are a leading cause of croup and hospitalizations. HPIV-1 and HPIV-2 are most frequently associated with outbreaks of croup, while HPIV-3 is more often associated with bronchiolitis and pneumonia. 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 / HMPV / HPIV Antigen Combo 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 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
7-in-1 Combo Detection – Seven Major Respiratory Pathogens in One Test
The GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HMPV / HPIV Antigen Combo Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating seven major respiratory pathogens from a single patient sample. This septuple detection capability helps healthcare providers rapidly identify the causative pathogen among COVID-19, influenza A, influenza B, RSV, adenovirus, Mycoplasma pneumoniae, human metapneumovirus, and human parainfluenza virus, which present with similar symptoms, enabling timely treatment decisions and improved patient outcomes.
| Feature | Benefit |
|---|---|
| 7-in-1 combo detection | Simultaneously detects SARS-CoV-2, Flu A, Flu B, RSV, ADV, MP, HMPV, and HPIV in one test |
| Single-sample workflow | Reduces the need for multiple specimen collections |
| Differentiation capability | Distinguishes between seven major respiratory pathogens |
| hMPV, MP, and HPIV detection included | Addresses significant and often underdiagnosed 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 – 15 Minutes
The GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HMPV / HPIV Antigen Combo Rapid Test US provides qualitative results in just 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 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 / HMPV / HPIV 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 / HMPV / HPIV 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 metapneumovirus, and human parainfluenza virus 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 metapneumovirus detection is particularly valuable for pediatric and geriatric patient populations. hMPV is an RNA virus that causes acute respiratory tract infections, particularly in infants, young children, and elderly individuals. Because clinical symptoms closely resemble RSV infection, laboratory confirmation is essential. The inclusion of Mycoplasma pneumoniae detection supports early confirmation of atypical pneumonia and enables timely initiation of appropriate therapy. The inclusion of human parainfluenza virus detection is valuable for pediatric settings, as HPIVs are a common cause of croup, bronchiolitis, and pneumonia in young children. By detecting all seven 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, HMPV, and HPIV |
| Pediatric relevance | HMPV, MP, and HPIV detection particularly useful in pediatric settings |
| Atypical pneumonia assessment | Supports early identification of Mycoplasma pneumoniae infection |
| Infection control support | Enables prompt isolation and cohorting decisions |
| Clinical versatility | Useful across physician offices, urgent care, and emergency settings |
Clinical Performance – High Specificity and Reliable Detection
The GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HMPV / HPIV Antigen Combo Rapid Test US is designed to deliver high sensitivity and specificity across all seven 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 | 96.4% | 99.0% | 98.5% |
| Influenza A | 95.0% | 99.1% | 98.0% |
| Influenza B | 92.9% | 99.1% | 97.5% |
| RSV | 94.3% | 96.2% | 96.0% |
| Adenovirus (ADV) | 96.9% | 98.6% | 98.2% |
| Mycoplasma pneumoniae (MP) | 96.6% | 97.7% | 97.2% |
| Human Metapneumovirus (HMPV) | 92.0% | 100% | 96.3% |
| Human Parainfluenza Virus (HPIV) | 93.8% | 98.5% | 97.5% |
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 / HMPV / HPIV 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 / HMPV / HPIV Antigen Combo Rapid Test US |
| Product Type | SARS-CoV-2 / Influenza A&B / RSV / Adenovirus / Mycoplasma pneumoniae / Human Metapneumovirus / Human Parainfluenza Virus 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 metapneumovirus antigen, and human parainfluenza virus 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 metapneumovirus antigen; Human parainfluenza virus antigen |
| Specimen | Nasal swab / Nasopharyngeal swab |
| Time to Result | 15 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 | 1T / 5T / 25T |
| Kit Contents | Test Cassette, Extraction Buffer, Disposable Swabs, Biohazard Specimen Bag, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM SARS-CoV-2 / Flu A&B / RSV / ADV / MP / HMPV / HPIV Antigen Combo Rapid Test US |
|---|---|
| 7-in-1 combo detection | Simultaneous detection and differentiation of seven major respiratory pathogens |
| 15-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, HMPV, and HPIV |
| hMPV, MP, and HPIV detection | Addresses important and often underdiagnosed respiratory pathogens |
| Pediatric relevance | HMPV, MP, and HPIV detection particularly valuable in pediatric settings |
| High specificity | Reliable detection across all seven 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 | Septuple 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 / HMPV / HPIV 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.
