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Global Healthcare Medical
GHM Ebola Antigen Rapid Test US – Qualitative Detection of Ebolavirus Antigens with 15-Minute Results, Whole Blood Sample Compatibility, and Professional Point-of-Care Use
GHM Ebola Antigen Rapid Test US – Qualitative Detection of Ebolavirus Antigens with 15-Minute Results, Whole Blood Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Ebola Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Ebola Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of antigens from viruses within the Ebolavirus genus in human whole blood specimens. The kit is intended for use by healthcare professionals as an aid in the diagnosis of Ebola virus disease (EVD) in patients with signs and symptoms consistent with EVD who have epidemiological risk factors for Ebolavirus exposure.
Ebola virus disease (EVD) is a rare but severe and often fatal illness caused by viruses in the genus Orthoebolavirus. While four species in the genus have been noted to cause human disease, the most severe disease and the most common cause of outbreaks is consistently associated with the Zaire ebolavirus. Ebolaviruses are maintained in nature through fruit bats, with introduction into human populations occurring through close contact with infected animals, followed by human-to-human transmission via direct contact with blood or body fluids of infected individuals. The initial symptoms usually occur 2 to 21 days post-infection and are nonspecific, including fever, fatigue, headache, sore throat, and muscle pain, making early clinical diagnosis challenging. As the disease progresses, patients may experience nausea, vomiting, diarrhea, hemodynamic instability, and hemorrhagic manifestations in severe cases. The 2013–2016 Ebola outbreak in West Africa was the largest and most complex since the virus was first discovered in 1976, with more cases and deaths than all other outbreaks combined, highlighting the critical need for rapid diagnostic tools in resource-limited settings.
Rapid diagnostic tests (RDTs) for viral antigen detection play a crucial role in outbreak response through the decentralization of testing and supporting timely decision-making for community-level outbreak control measures. The WHO target product profile for RDTs for EBOV sets acceptable clinical sensitivity and specificity of >95% and >99%, respectively. The GHM Ebola Antigen Rapid Test US provides a rapid, point-of-care solution for the presumptive detection of Ebolavirus antigens, enabling faster case identification and isolation, and supporting the initiation of treatment to improve outcomes.
The GHM Ebola 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 whole blood specimens collected by venipuncture or fingerstick, providing flexible sample collection options suitable for use in field and resource-limited settings where laboratory infrastructure may be limited.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including emergency departments, infectious disease clinics, and public health outbreak response programs. 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 Ebola Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to Ebolavirus antigens, along with immobilized capture antibodies on the test line. During testing, the 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 Ebolavirus antigens are present in the specimen. The test detects antigens from viruses within the Ebolavirus genus, including Zaire ebolavirus, Sudan ebolavirus, and Bundibugyo ebolavirus.
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Ebolavirus-specific monoclonal antibodies | Targeted detection of Ebolavirus antigens |
| Detects multiple Ebolavirus species | Comprehensive coverage of circulating Ebolavirus strains |
| Qualitative visual result | Clear and interpretable test outcome |
| No equipment required | Simple and efficient testing workflow in field settings |
| Internal procedural control | Confirms proper test performance |
Fast Results – 15 Minutes
The GHM Ebola 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. Rapid detection of suspected EVD is key to effective outbreak control, resulting in faster case identification and isolation, and initiation of treatment to improve outcomes.
| Feature | Benefit |
|---|---|
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for emergency departments and outbreak response settings |
| Efficient workflow | Enables immediate patient assessment |
| Quick sample-to-result | Supports high-throughput testing environments |
Whole Blood Sample Compatibility – Simple and Efficient Collection
The GHM Ebola Antigen Rapid Test US is compatible with whole blood specimens collected by venipuncture or fingerstick, providing simple and efficient sample collection methods suitable for a wide range of clinical and field settings. The test requires only a small sample volume, making it practical for use in resource-limited environments where laboratory infrastructure may be limited.
| Feature | Benefit |
|---|---|
| Whole blood specimen | Simple and efficient sample collection |
| Venipuncture or fingerstick | Flexible collection options for different clinical settings |
| Small sample volume required | Practical for field and decentralized testing |
| No special equipment required | Streamlined workflow in resource-limited settings |
Clinical Utility – Aid for Diagnosis of Ebola Virus Disease
The GHM Ebola Antigen Rapid Test US is intended for use as an aid in the diagnosis of Ebola virus disease (EVD) in patients suspected of and with signs or symptoms consistent with EVD who have epidemiological risk factors for Ebolavirus exposure. The test provides rapid etiological diagnosis, enabling timely clinical decision-making and supporting patient management.
The test is particularly valuable in settings where rapid identification of EVD supports outbreak control measures and timely clinical intervention. Rapid antigen detection can guide initial patient care while confirmatory analyses are performed by reference services. The test is also suitable for use in decentralized testing environments and field diagnostic programs where laboratory infrastructure may be limited.
Important: Test results are presumptive. Definitive identification of EVD requires performing additional testing and confirmation procedures in consultation with public health and/or other authorities to whom reporting is required. Negative results were observed in individuals with low levels of circulating virus; therefore, negative results do not preclude infection with viruses within the Ebolavirus genus.
| Feature | Benefit |
|---|---|
| Early infection detection aid | Supports early identification of EVD in symptomatic patients |
| Rapid etiological diagnosis | Enables timely initiation of supportive care measures |
| Field-friendly testing | No instrumentation required, suitable for decentralized settings |
| Outbreak response support | Enables rapid case identification during outbreaks |
| Clinical versatility | Useful across emergency departments, infectious disease clinics, and public health settings |
High Specificity – Trusted Clinical Performance
The GHM Ebola Antigen Rapid Test US is designed to deliver reliable clinical performance with high specificity. Published evaluations of Ebolavirus antigen rapid diagnostic tests have demonstrated high specificity, supporting their use to "rule-in" patients with EVD. All evaluated Ag-RDTs in a recent laboratory study demonstrated 100% clinical specificity with no cross-reactivity.
| Parameter | Specification |
|---|---|
| Specificity | High specificity demonstrated in published evaluations |
| Clinical Specificity | 100% clinical specificity demonstrated in laboratory evaluations |
| Cross-reactivity | No cross-reactivity observed with common febrile illness pathogens, including Marburg, Crimean Congo Hemorrhagic Fever, Lassa, Rift Valley Fever, Yellow Fever, Chikungunya, Influenza A/B, Rotavirus, Adenovirus, RSV, Enterovirus, Salmonella, Shigella, Vibrio cholera, Streptococcus pneumoniae, Haemophilus influenzae, Leptospira, Neisseria meningitidis, Yersinia enterocolitica, Plasmodium falciparum (malaria), Plasmodium vivax (malaria), Trypanosoma cruzi, Rickettsia africae, and Dengue |
Performance characteristics based on published evaluations of Ebolavirus antigen rapid diagnostic tests. Systematic review and meta-analysis of antigen rapid diagnostic tests to detect Zaire ebolavirus reported pooled sensitivity of 82.1% and specificity of 97.0%. The WHO target product profile for RDTs for EBOV sets acceptable clinical sensitivity and specificity of >95% and >99%, respectively. Clinical sensitivity of Ag-RDTs is higher in specimens with higher viral loads, and the test is best suited for use in symptomatic patients with high viral loads.
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 Ebola 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 Ebola Antigen Rapid Test US |
| Product Type | Ebola Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of antigens from viruses within the Ebolavirus genus in human whole blood specimens; used as an aid in the diagnosis of Ebola virus disease (EVD) in patients with signs and symptoms consistent with EVD who have epidemiological risk factors for Ebolavirus exposure |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antigens | Ebolavirus antigens (Zaire ebolavirus, Sudan ebolavirus, Bundibugyo ebolavirus) |
| Specimen | Whole Blood (venipuncture or fingerstick) |
| Time to Result | 15 minutes |
| Specificity | High specificity demonstrated in published evaluations; 100% clinical specificity in laboratory evaluations |
| Cross-reactivity | No cross-reactivity observed with common febrile illness pathogens |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Emergency department, infectious disease clinic, public health outbreak response program, point-of-care |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system; CE marked |
| Intended User | Professional healthcare use only |
| Kit Sizes | 20 tests/kit; 25 tests/kit |
| Kit Contents | Ebola Antigen Test Cassette, Sample Buffer, Disposable Droppers, Instructions for Use |
Important Biosafety Note: Due to the high pathogenicity of Ebolaviruses, laboratory handling of samples requires enhanced biosafety precautions. Testing for Ebola Virus Disease (EVD) must be performed in accordance with current guidelines provided by the appropriate public health authorities that address appropriate biosafety conditions, interpretation of test results, and coordination of testing, results, and patient management with public health authorities.
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Ebola Antigen Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood sample compatibility | Simple and efficient sample collection |
| Ebolavirus-specific detection | Targeted detection of Ebolavirus antigens |
| Detects multiple Ebolavirus species | Comprehensive coverage of circulating Ebolavirus strains |
| High specificity | High specificity demonstrated in published evaluations |
| No cross-reactivity | No cross-reactivity with common febrile illness pathogens |
| Field-friendly testing | No instrumentation required, suitable for remote settings |
| Outbreak response support | Enables rapid case identification during outbreaks |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for emergency departments and outbreak response settings |
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 Ebola 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.
