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Global Healthcare Medical
GHM Dengue NS1 Antigen Rapid Test US – Qualitative Detection of Dengue Virus NS1 Antigen with 10-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM Dengue NS1 Antigen Rapid Test US – Qualitative Detection of Dengue Virus NS1 Antigen with 10-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Dengue NS1 Antigen Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Dengue NS1 Antigen Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of dengue virus non-structural protein 1 (NS1) antigen in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as an aid in the early diagnosis of dengue virus infection.
Dengue is the most prevalent mosquito-borne viral disease worldwide, with a tenfold increase in incidence over the past two decades. In 2024, the World Health Organization received reports of 14,434,584 dengue cases, including 7,718,585 laboratory-confirmed cases, 52,738 severe cases, and 11,201 deaths across all six regions — marking the highest global dengue burden ever recorded, with cases reported in more than 100 countries. Approximately half of the world's population is now thought to be at risk of this virus transmitted by infected mosquitoes.
Dengue virus belongs to the Flaviviridae family and has four distinct serotypes (DENV-1, DENV-2, DENV-3, and DENV-4). NS1 is a non-structural protein secreted into the bloodstream during early dengue virus infection. Unlike antibodies that take days to appear, NS1 antigen is detectable as early as Day 1 of fever, making NS1 antigen testing the recommended approach for identifying dengue virus infections during the first 7 days of illness. Its detection aids in early dengue confirmation, facilitates patient triage during outbreaks, allows rapid case differentiation in endemic zones, and provides actionable results before seroconversion. A positive NS1 antigen test result confirms dengue virus infection without providing serotype information. In 2025, the World Health Organization updated its interim recommendations on the laboratory diagnosis of dengue, recognizing that a rapid diagnostic test (RDT) detecting the NS1 antigen can be used to confirm a case of dengue in high-prevalence settings, thereby helping to facilitate the early identification of cases.
The GHM Dengue NS1 Antigen Rapid Test US delivers qualitative results in just 10 minutes, supporting rapid clinical decision-making at the point of care. The test is compatible with whole blood, serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings, including primary care and decentralized healthcare environments.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including primary care clinics, hospitals, emergency departments, and dengue screening programs in endemic areas. 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 Dengue NS1 Antigen Rapid Test US is based on lateral flow immunochromatography technology. The test strip contains colloidal gold-conjugated monoclonal antibodies specific to the dengue NS1 antigen, 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 dengue NS1 antigen is present in the specimen. The test targets antigens from all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4).
| Feature | Benefit |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection method |
| Dengue NS1-specific monoclonal antibodies | Targeted detection of dengue NS1 antigen |
| Detects all four dengue serotypes (DENV-1 to DENV-4) | Comprehensive coverage of circulating dengue strains |
| Qualitative visual result | Clear and interpretable test outcome |
| No equipment required | Simple and efficient testing workflow |
Fast Results – 10 Minutes
The GHM Dengue NS1 Antigen Rapid Test US provides qualitative results in just 10 minutes, supporting rapid clinical decision-making and efficient patient workflow in point-of-care settings. NS1 antigen testing is recommended to identify dengue virus infections during the first 7 days of illness, when NS1 antigen levels are typically highest.
| Feature | Benefit |
|---|---|
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Early-phase detection capability | Optimized for the first 1–5 days of symptom onset |
| Point-of-care compatibility | Suitable for primary care clinics and emergency departments |
| Efficient workflow | Enables immediate patient triage and case management |
Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection
The GHM Dengue NS1 Antigen Rapid Test US is compatible with whole blood (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options to accommodate different clinical protocols and patient needs. The test is particularly well-suited for decentralized healthcare settings where laboratory infrastructure may be limited.
| Feature | Benefit |
|---|---|
| Whole blood / serum / plasma | Flexible sample collection options |
| Venipuncture or fingerstick whole blood | Suitable for different clinical settings |
| No special equipment required | Streamlined workflow in resource-limited settings |
| Simple procedure | Convenient for routine testing |
Clinical Utility – Aid for Early Diagnosis of Dengue Virus Infection
The GHM Dengue NS1 Antigen Rapid Test US is intended for use as an aid in the early diagnosis of dengue virus infection. NS1 antigen is detectable during the acute phase of dengue virus infections, and NS1 antigen tests can be as sensitive as molecular tests during the first 7 days of symptoms. The test provides rapid etiological diagnosis, enabling timely clinical decision-making and supporting patient management.
The test is particularly valuable in dengue-endemic areas and during outbreak settings, where rapid identification of cases supports timely clinical management and infection control measures. Early and accurate diagnosis of dengue, supported by rapid laboratory assessment, is essential for reducing dengue mortality through appropriate clinical management, including oral and intravenous rehydration. Combining NS1 antigen detection with IgM serology enhances diagnostic accuracy, particularly for samples collected more than three days after symptom onset.
| Feature | Benefit |
|---|---|
| Early infection detection aid | Supports identification of acute dengue infection during the first 7 days |
| Pre-seroconversion detection | Provides actionable results before IgM/IgG antibodies become detectable |
| Outbreak response support | Enables rapid case identification and patient triage during outbreaks |
| Dengue screening support | Suitable for screening programs in endemic areas |
| Clinical versatility | Useful across primary care clinics, hospitals, and emergency departments |
High Accuracy – Trusted Clinical Performance
The GHM Dengue NS1 Antigen Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity. Clinical evaluation against RT-PCR and ELISA methods has demonstrated strong performance, making this assay a reliable tool for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 97.4% |
| Specificity | 100% |
| Overall Agreement | 99.4% |
| Limit of Detection | DEN-1 to DEN-4: 3.5×10⁻³ to 6.25×10⁻² mg/mL |
| Cross-reactivity | No cross-reactivity observed with Influenza A/B, RSV, Adenovirus, HIV, HCV, HBV, Syphilis, or H. pylori |
Performance characteristics based on comparison with commercial ELISA (EIA) methods. Detection is optimal during the first 1–5 days of symptom onset, when NS1 antigen levels are highest. Published studies of rapid NS1 assays report sensitivity ranging from 73.5% to 97.4% depending on the product, patient population, and timing of specimen collection.
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 Dengue NS1 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 Dengue NS1 Antigen Rapid Test US |
| Product Code | DNS1-502b |
| Product Type | Dengue NS1 Antigen Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of dengue virus NS1 antigen in human whole blood, serum, or plasma specimens; used as an aid in the early diagnosis of dengue virus infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antigen | Dengue virus NS1 antigen (all four serotypes: DENV-1, DENV-2, DENV-3, DENV-4) |
| Specimen | Whole Blood / Serum / Plasma |
| Time to Result | 10 minutes |
| Sensitivity | 97.4% |
| Specificity | 100% |
| Overall Agreement | 99.4% |
| Limit of Detection | DEN-1 to DEN-4: 3.5×10⁻³ to 6.25×10⁻² mg/mL |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Primary care clinic, hospital, emergency department, dengue screening program in endemic areas, 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 | Dengue NS1 Antigen Test Cassette, Sample Buffer, Sterile Dropper, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Dengue NS1 Antigen Rapid Test US |
|---|---|
| Colloidal gold immunochromatography | Established and reliable detection technology |
| 10-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood / serum / plasma compatibility | Flexible and convenient sampling options |
| Dengue NS1-specific detection | Targeted detection of dengue NS1 antigen |
| Detects all four dengue serotypes | Comprehensive coverage of circulating strains |
| Early-phase detection capability | Optimized for the first 7 days of illness |
| High sensitivity and specificity | 97.4% sensitivity and 100% specificity |
| 99.4% overall agreement | Strong concordance with reference methods |
| No cross-reactivity | No cross-reactivity with common respiratory and bloodborne pathogens |
| WHO guideline-aligned testing | Consistent with WHO interim recommendations for NS1 RDT use in high-prevalence settings |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for primary care clinics, hospitals, and emergency departments |
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 Dengue NS1 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.
