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Global Healthcare Medical
GHM SARS-CoV-2 / Flu A&B / RSV Antigen Combo Test US – 4-in-1 Qualitative Detection of SARS-CoV-2, Influenza A & B, and RSV Antigens with 8-Minute Results, Nasal / Nasopharyngeal Swab Sample Compatibility, and Professional Point-of-Care Use
GHM SARS-CoV-2 / Flu A&B / RSV Antigen Combo Test US – 4-in-1 Qualitative Detection of SARS-CoV-2, Influenza A & B, and RSV Antigens with 8-Minute Results, Nasal / Nasopharyngeal Swab Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM SARS-CoV-2 / Flu A&B / RSV Antigen Combo Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM SARS-CoV-2 / Flu A&B / RSV Antigen Combo 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, and respiratory syncytial virus (RSV) nucleoprotein 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 SARS-CoV-2, influenza A/B, and RSV 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. Rapid diagnostics of these viruses are essential not only for clinical management but also for infection control and epidemiological surveillance. This combo test provides a single-sample, single-test solution for the simultaneous detection and differentiation of all four major respiratory pathogens, supporting efficient clinical workflow and reducing the need for multiple specimen collections.
The GHM SARS-CoV-2 / Flu A&B / RSV Antigen Combo 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
4-in-1 Combo Detection – SARS-CoV-2, Flu A, Flu B, and RSV in One Test
The GHM SARS-CoV-2 / Flu A&B / RSV Antigen Combo Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating four major respiratory pathogens from a single patient sample. This quadruple detection capability helps healthcare providers rapidly identify the causative pathogen among COVID-19, influenza A, influenza B, and RSV, which present with similar symptoms, enabling timely treatment decisions and improved patient outcomes.
| Feature | Benefit |
|---|---|
| 4-in-1 combo detection | Simultaneously detects SARS-CoV-2, Flu A, Flu B, and RSV in one test |
| Single-sample workflow | Reduces the need for multiple specimen collections |
| Differentiation capability | Distinguishes between four major respiratory pathogens |
| Nucleoprotein/nucleocapsid targets | Conserved viral antigens for consistent detection |
Fast Results – 8 Minutes
The GHM SARS-CoV-2 / Flu A&B / RSV Antigen Combo 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 Antigen Combo Test US is compatible with both nasal and nasopharyngeal swab specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs.
| 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 Antigen Combo Test US is intended for use as an aid in the diagnosis of active SARS-CoV-2, influenza A/B, and RSV infection. Antigen testing is most effective when performed within the first five to seven days of symptom onset, when viral 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.
| 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, and RSV |
| 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 Antigen Combo Test US is designed to deliver high specificity across all four target pathogens. Clinical studies of combined rapid antigen tests for respiratory pathogens have demonstrated high specificity exceeding 99% for SARS-CoV-2, influenza A/B, and RSV, making them valuable tools for point-of-care diagnostics when correctly used. The test is calibrated to perform optimally in samples with high viral loads, where antigen rapid tests achieve their highest sensitivity.
| Target | Sensitivity | Specificity | Accuracy |
|---|---|---|---|
| SARS-CoV-2 | 97.2% | 99.5% | 98.7% |
| Influenza A | 95.4% | 99.0% | 98.0% |
| Influenza B | 95.3% | 99.5% | 98.5% |
| RSV | 95.7% | 99.1% | 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 SARS-CoV-2 / Flu A&B / RSV Antigen Combo 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 Antigen Combo Test US |
| Product Code | RVC-545b |
| Product Type | SARS-CoV-2 / Influenza A&B / RSV 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, and RSV nucleoprotein 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 |
| 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 | 1T / 5T / 25T |
| Kit Contents | Test Cassette, Extraction Buffer Tube, Disposable Swab, Tube Holder, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM SARS-CoV-2 / Flu A&B / RSV Antigen Combo Test US |
|---|---|
| 4-in-1 combo detection | Simultaneous detection and differentiation of SARS-CoV-2, Flu A, Flu B, and RSV |
| 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, and RSV |
| High specificity | Reliable detection across all four 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 | Quadruple 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 Antigen Combo 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.
