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Global Healthcare Medical
GHM SARS-CoV-2 Antigen Rapid Test US – Qualitative Detection of SARS-CoV-2 Nucleocapsid Antigen with 15-Minute Results, Nasal Swab Sample Compatibility, and Professional Point-of-Care Use
GHM SARS-CoV-2 Antigen Rapid Test US – Qualitative Detection of SARS-CoV-2 Nucleocapsid Antigen with 15-Minute Results, Nasal Swab Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM SARS-CoV-2 Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM SARS-CoV-2 Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of SARS-CoV-2 nucleocapsid 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 infection in symptomatic individuals.
SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) is the virus responsible for COVID-19. Antigen testing detects viral proteins present in respiratory specimens during the acute phase of infection. The nucleocapsid (N) protein is a highly conserved and abundant viral antigen, making it a suitable target for rapid diagnostic detection. Antigen rapid tests are well-calibrated to infectiousness and play a critical role in the COVID-19 public health response.
The GHM SARS-CoV-2 Antigen 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
Colloidal Gold Immunochromatography – Reliable Qualitative Detection
The GHM SARS-CoV-2 Antigen Rapid Test US is based on colloidal gold immunochromatography technology, utilizing a sandwich immunoassay format. The test strip contains colloidal gold-conjugated antibodies specific to the SARS-CoV-2 nucleocapsid protein, along with immobilized capture antibodies on the test line. When a nasal swab specimen is processed and applied to the test device, the presence of SARS-CoV-2 antigen produces a visible colored line at the test position.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Sandwich immunoassay format | Targeted detection of SARS-CoV-2 nucleocapsid antigen |
| Nucleocapsid protein target | Highly conserved viral antigen for consistent detection |
| Qualitative visual result | Clear and interpretable test outcome |
Fast Results – 15 Minutes
The GHM SARS-CoV-2 Antigen 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 Antigen 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 Infection Detection
The GHM SARS-CoV-2 Antigen Rapid Test US is intended for use as an aid in the diagnosis of active SARS-CoV-2 infection. Antigen testing is most effective when performed within the first 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 infection |
| Monitoring utility | Supports clinical assessment of symptomatic patients |
| 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 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 SARS-CoV-2 Antigen Rapid Test US |
| Product Type | SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of SARS-CoV-2 nucleocapsid antigen in human nasal swab specimens; used as an aid in the diagnosis of active COVID-19 infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold sandwich immunoassay |
| Target Antigen | SARS-CoV-2 nucleocapsid (N) protein |
| 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 Antigen Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 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 |
| 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 marker | Nucleocapsid antigen detection supports 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 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.
