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Global Healthcare Medical
GHM SARS-CoV-2 / Flu A&B Antigen Combo Rapid Test US – 3-in-1 Qualitative Detection of SARS-CoV-2, Influenza A & B Antigens with 15-Minute Results, Nasal Swab Sample Compatibility, and Professional Point-of-Care Use
GHM SARS-CoV-2 / Flu A&B Antigen Combo Rapid Test US – 3-in-1 Qualitative Detection of SARS-CoV-2, Influenza A & B Antigens with 15-Minute Results, Nasal Swab Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM SARS-CoV-2 / Flu A&B Antigen Combo Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM SARS-CoV-2 / Flu A&B Antigen Combo Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen, influenza A nucleoprotein antigen, and influenza B nucleoprotein antigen in human nasal swab specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of active COVID-19 and influenza A/B infections in symptomatic individuals.
Respiratory infections caused by SARS-CoV-2 and influenza viruses often present with similar clinical symptoms, including fever, cough, sore throat, and fatigue. Differentiating between these pathogens is essential for appropriate clinical management and timely treatment decisions. This combo test provides a single-sample, single-test solution for the simultaneous detection and differentiation of all three targets, supporting efficient clinical workflow and reducing the need for multiple specimen collections.
The GHM SARS-CoV-2 / Flu A&B 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 anterior nasal swab specimens, providing a less invasive sample collection method 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, 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
3-in-1 Combo Detection – SARS-CoV-2, Flu A, and Flu B in One Test
The GHM SARS-CoV-2 / Flu A&B Antigen Combo Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating three respiratory pathogens from a single patient sample. This triple detection capability helps healthcare providers distinguish between COVID-19 and seasonal influenza infections, which present with similar symptoms, enabling timely treatment decisions and improved patient outcomes.
| Feature | Benefit |
|---|---|
| Triple detection capability | Differentiates SARS-CoV-2, influenza A, and influenza B in one test |
| Single-sample workflow | Reduces the need for multiple specimen collections |
| Combo antigen detection | Simultaneous qualitative detection and differentiation |
| Nucleocapsid/nucleoprotein targets | Conserved viral antigens for consistent detection |
Fast Results – 15 Minutes
The GHM SARS-CoV-2 / Flu A&B 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 Swab Sample Compatibility – Less Invasive Collection
The GHM SARS-CoV-2 / Flu A&B Antigen Combo Rapid Test US is compatible with anterior nasal swab specimens, providing a less invasive and more comfortable sample collection method compared to nasopharyngeal swabs.
| Feature | Benefit |
|---|---|
| Anterior nasal swab | Less invasive sample collection |
| Simple procedure | Convenient for routine testing |
| Patient-friendly | Improved comfort during specimen collection |
| 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 Antigen Combo Rapid Test US is intended for use as an aid in the diagnosis of active SARS-CoV-2 and influenza A/B infection. Antigen testing is most effective when performed within the first five to seven days of symptom onset, when viral loads are typically highest.
| 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 from influenza A/B |
| Clinical versatility | Useful across physician offices, urgent care, and emergency settings |
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 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 Antigen Combo Rapid Test US |
| Product Type | SARS-CoV-2 / Influenza A&B Antigen Combo Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen, influenza A nucleoprotein antigen, and influenza B nucleoprotein antigen in human nasal swab specimens; used as an aid in the diagnosis of active COVID-19 and influenza A/B infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold sandwich immunoassay |
| Target Antigens | SARS-CoV-2 nucleocapsid (N) protein; Influenza A nucleoprotein; Influenza B nucleoprotein |
| Specimen | Anterior nasal swab |
| Test Time | 15 minutes |
| Storage Temperature | 2–30°C |
| Shelf Life | 24 months |
| Application Scenario | Physician office laboratory, urgent care center, emergency department, clinical laboratory, point-of-care |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system; CE marked |
| Intended User | Professional healthcare use only |
| Package Options | 20 tests/kit; 25 tests/kit |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM SARS-CoV-2 / Flu A&B Antigen Combo Rapid Test US |
|---|---|
| 3-in-1 combo detection | Simultaneous detection and differentiation of SARS-CoV-2, Flu A, and Flu B |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Nasal swab compatibility | Less invasive and patient-friendly sampling |
| Active infection detection aid | Supports early identification of symptomatic cases |
| Differential diagnosis support | Helps distinguish COVID-19 from influenza A/B |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for physician offices, urgent care, and laboratories |
| Reliable respiratory panel | Triple antigen detection supports comprehensive 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 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.
