WhatsApp USA: +1 6032769350 | WhatsApp HK: +852 63697831
Global Healthcare Medical
GHM Human Metapneumovirus (HMPV) Antigen Rapid Test US – Qualitative Detection of Human Metapneumovirus Antigen with 8-Minute Results, Nasal / Nasopharyngeal Swab Sample Compatibility, and Professional Point-of-Care Use
GHM Human Metapneumovirus (HMPV) Antigen Rapid Test US – Qualitative Detection of Human Metapneumovirus Antigen with 8-Minute Results, Nasal / Nasopharyngeal Swab Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Human Metapneumovirus (HMPV) Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Human Metapneumovirus (HMPV) Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of human metapneumovirus (HMPV) 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 HMPV respiratory infection in symptomatic individuals.
Human metapneumovirus (hMPV) is a significant respiratory pathogen belonging to the Pneumoviridae family, primarily impacting young, elderly, and immunocompromised populations. Clinical presentations are similar to those of other respiratory viruses such as respiratory syncytial virus (RSV), influenza, and SARS-CoV-2, and can still lead to serious complications including bronchiolitis, pneumonia, and asthma or COPD exacerbations. A comprehensive review published in 2025 reported a 6.24% infection rate in hospitalized patients presenting with acute respiratory infections (ARIs), and estimated 473,000 hMPV-associated hospitalizations globally. In 2018, up to 14.2 million cases of hMPV were reported in children aged under 5 years worldwide, resulting in 7,700 in-hospital deaths. Given the morbidity and mortality rates of hMPV, which are comparable to those of influenza and RSV, enhanced surveillance and prevention are essential.
Because reinfection is common and symptoms overlap with RSV and influenza, rapid antigen-based detection plays a key role in differential diagnosis. Rapid hMPV testing enables clinicians to identify viral etiology at the point of care, avoid unnecessary antibiotic prescriptions, improve patient counseling and follow-up decisions, and reduce referrals and additional diagnostic testing. The GHM HMPV 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 HMPV Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test incorporates monoclonal antibodies specific for Human Metapneumovirus antigen conjugated to visible labeling particles, detecting both major hMPV genotypes (A and B). 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 HMPV antigen is present in the specimen.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| HMPV-specific monoclonal antibodies | Targeted detection of HMPV nucleocapsid protein antigen |
| Detects both major hMPV genotypes (A and B) | Comprehensive coverage of circulating hMPV strains |
| Qualitative visual result | Clear and interpretable test outcome |
| No equipment required | Simple and efficient testing workflow |
Fast Results – 8 Minutes
The GHM HMPV 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 physician offices |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput testing environments |
Nasal / Nasopharyngeal Swab Compatibility – Flexible Sample Collection
The GHM HMPV 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. Optimized for early-stage infection, the test detects viral antigen at the point when hMPV viral load is typically highest and clinical symptoms are most pronounced.
| 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 HMPV Respiratory Infection
The GHM HMPV Antigen Rapid Test US is intended for use as an aid in the diagnosis of HMPV respiratory infection. Antigen testing is most effective during the acute phase of respiratory illness, when symptoms often resemble the common cold, RSV, or influenza. The test provides rapid etiological diagnosis, enabling timely clinical decision-making and supporting infection control measures.
The test is particularly valuable for pediatric, geriatric, and immunocompromised patient populations, where hMPV infections are more prevalent and can be clinically severe. Early identification of HMPV infection supports appropriate patient management, reduces unnecessary antibiotic use, and helps limit hospitalizations. As no direct antiviral therapy for hMPV currently exists, rapid confirmation of hMPV can help avoid unnecessary empirical antibiotic therapy and repeated diagnostic workups in children, thereby improving patient management.
| Feature | Benefit |
|---|---|
| Active infection detection aid | Supports identification of current HMPV infection |
| Early symptomatic phase utility | Optimized for the acute phase of respiratory infection |
| Differential diagnosis support | Helps distinguish HMPV from RSV, influenza, and other viral causes |
| Pediatric relevance | Particularly useful in pediatric clinical settings |
| Geriatric relevance | Valuable for older adult patient populations |
| Antibiotic stewardship support | Helps reduce unnecessary empirical antibiotic use |
| 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 HMPV Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluation against PCR methods has demonstrated high relative sensitivity, specificity, and overall accuracy, making this assay a reliable frontline diagnostic tool for routine respiratory testing and outbreak settings.
| Parameter | Specification |
|---|---|
| Sensitivity | 92.0% |
| Specificity | 100% |
| Accuracy | 96.3% |
| Limit of Detection | Genotype A: 4.5 × 10³ TCID₅₀/mL; Genotype B: 3.0 × 10³ TCID₅₀/mL |
| Cross-reactivity | No cross-reactivity observed with common respiratory viruses, including Influenza A/B, RSV, Adenovirus, Rhinovirus, or seasonal human coronaviruses |
Performance characteristics based on PCR comparison studies of rapid hMPV antigen assays. Detection is optimal in specimens with high viral loads (Ct < 28), where positive agreement reaches 100%.
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 HMPV 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 Human Metapneumovirus (HMPV) Antigen Rapid Test US |
| Product Code | HMPV-502b |
| Product Type | Human Metapneumovirus (HMPV) Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of human metapneumovirus (HMPV) antigen directly from human nasal or nasopharyngeal swab specimens; used as an aid in the diagnosis of HMPV respiratory infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antigen | HMPV nucleocapsid protein antigen |
| Specimen | Nasal swab / Nasopharyngeal swab |
| Time to Result | 8 minutes |
| Sensitivity | 92.0% |
| Specificity | 100% |
| Accuracy | 96.3% |
| Limit of Detection | Genotype A: 4.5 × 10³ TCID₅₀/mL; Genotype B: 3.0 × 10³ TCID₅₀/mL |
| 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 Size | 25 tests/kit |
| Kit Contents | Test Cassette, Extraction Buffer Tube, Disposable Swab, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Human Metapneumovirus (HMPV) 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 |
| HMPV nucleocapsid protein-specific detection | Targeted detection of HMPV antigen |
| Detects both major hMPV genotypes (A and B) | Comprehensive coverage of circulating strains |
| High sensitivity and specificity | 92.0% sensitivity and 100% specificity |
| 100% positive agreement at high viral loads | Optimal performance in acute-phase specimens (Ct < 28) |
| No cross-reactivity | No cross-reactivity with common respiratory viruses |
| Pediatric relevance | Particularly valuable in pediatric clinical settings |
| Geriatric relevance | Valuable for older adult patient populations |
| Antibiotic stewardship support | Helps reduce unnecessary empirical antibiotic use |
| 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 Human Metapneumovirus (HMPV) 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.
