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Global Healthcare Medical
GHM Flu A&B Antigen Rapid Test US – Qualitative Detection and Differentiation of Influenza A & B Nucleoprotein Antigens with 8-Minute Results, Nasal / Nasopharyngeal Swab Sample Compatibility, and Professional Point-of-Care Use
GHM Flu A&B Antigen Rapid Test US – Qualitative Detection and Differentiation of Influenza A & B Nucleoprotein Antigens with 8-Minute Results, Nasal / Nasopharyngeal Swab Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Flu A&B Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Flu A&B Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens directly from human nasal or nasopharyngeal swab specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of acute influenza A and influenza B viral infections in symptomatic individuals.
Influenza (commonly known as "the flu") is a highly contagious, acute viral infection of the respiratory tract. It is transmitted easily from person to person via droplets and small particles produced when infected people cough or sneeze. Influenza tends to spread rapidly in seasonal epidemics. Influenza A and B viruses are the two main types responsible for seasonal influenza in humans. Rapid differentiation of influenza A and B is essential for clinical management, infection control, and epidemiological surveillance, as antiviral treatment decisions often depend on the specific viral type.
The GHM Flu A&B 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 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 Flu A&B Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains colloidal gold-conjugated antibodies specific to influenza A and influenza B nucleoprotein antigens, along with immobilized capture antibodies on the test lines. 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 respective test line region (T1 for Influenza A, T2 for Influenza B) if the corresponding antigen is present.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Dual test lines (T1 & T2) | Separate detection and differentiation of influenza A and B antigens |
| Influenza nucleoprotein targets | Highly conserved viral antigens for consistent detection |
| Qualitative visual result | Clear and interpretable test outcome |
Fast Results – 8 Minutes
The GHM Flu A&B 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 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 Flu A&B 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. Nasopharyngeal swabs are strongly recommended for antigen testing as they generally yield higher viral loads and better test sensitivity compared to oropharyngeal swabs.
| 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 Influenza A & B
The GHM Flu A&B Antigen Rapid Test US is intended for use as an aid in the diagnosis of acute influenza A and influenza B viral infections. Antigen testing is most effective when performed within the first three to four days of symptom onset, when viral loads are typically highest. Rapid antigen diagnostic tests can rapidly detect influenza viruses, allowing for the prompt initiation of antiviral therapy and the prevention of nosocomial spread within hospital settings. Early confirmation of influenza type supports appropriate antiviral treatment decisions, including the use of neuraminidase inhibitors, and assists in the differential diagnosis of respiratory infections.
| Feature | Benefit |
|---|---|
| Active infection detection aid | Supports identification of current influenza A/B infection |
| Early symptomatic phase utility | Optimized for the acute phase of influenza infection |
| Differential diagnosis support | Helps distinguish influenza A from influenza B |
| Antiviral treatment support | Enables timely initiation of appropriate antiviral therapy |
| Infection control support | Enables prompt isolation and cohorting decisions |
| Clinical versatility | Useful across physician offices, urgent care, and emergency settings |
High Accuracy – Trusted Clinical Performance
The GHM Flu A&B Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity across both influenza A and influenza B targets. Clinical evaluations of rapid antigen tests for influenza have demonstrated strong performance, making them valuable tools for point-of-care diagnostics when correctly used.
| Target | Sensitivity | Specificity | Accuracy |
|---|---|---|---|
| Influenza A | 95.7% | 98.8% | 98.0% |
| Influenza B | 98.4% | 99.4% | 98.4% |
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 Flu A&B 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 Flu A&B Antigen Rapid Test US |
| Product Code | FLU-522b |
| Product Type | Influenza A&B Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection and differentiation of Influenza A & Influenza B viral antigens directly from human nasal or nasopharyngeal swab specimens; used as an aid in the diagnosis of acute influenza A and influenza B viral infections |
| Detection Principle | Lateral flow immunochromatography; colloidal gold sandwich immunoassay |
| Target Antigens | Influenza A nucleoprotein antigen; Influenza B nucleoprotein antigen |
| Specimen | Nasal swab / Nasopharyngeal swab |
| Time to Result | 8 minutes |
| Sensitivity | Influenza A: 95.7%; Influenza B: 98.4% |
| Specificity | Influenza A: 98.8%; Influenza B: 99.4% |
| Accuracy | Influenza A: 98.0%; Influenza B: 98.4% |
| 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, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Flu A&B 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 |
| Dual test lines (T1 & T2) | Separate detection and differentiation of Flu A and Flu B |
| High sensitivity and specificity | 95.7% sensitivity for Flu A; 98.4% sensitivity for Flu B |
| Antiviral treatment support | Enables timely initiation of appropriate antiviral therapy |
| 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 |
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 Flu A&B 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.
