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Global Healthcare Medical
GHM Dengue NS1 / IgG / IgM Combo Rapid Test US – 3-in-1 Qualitative Detection of Dengue NS1 Antigen, IgG & IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM Dengue NS1 / IgG / IgM Combo Rapid Test US – 3-in-1 Qualitative Detection of Dengue NS1 Antigen, IgG & IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Dengue NS1 / IgG / IgM Combo Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Dengue NS1 / IgG / IgM Combo Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of dengue virus NS1 antigen, IgG antibodies, and IgM antibodies in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as an aid in the 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). Clinical diagnosis alone is insufficient due to symptom overlap with other diseases such as malaria, chikungunya, and Zika fever, making laboratory confirmation critical. The diagnostic window for dengue spans from Day 1 through the convalescent phase: NS1 antigen is detectable during the first 0–7 days of illness, IgM antibodies become detectable on days 3–5 and last for 2–3 months, and IgG antibodies develop by the fourteenth day and last a lifetime. Combining NS1 antigen and IgM/IgG antibody detection is recognized as providing the most comprehensive diagnostic picture across all stages of infection, and studies have shown that combination testing achieves the best compromise of sensitivity and specificity for patients presenting at different times after fever onset. In 2025, the World Health Organization updated its interim recommendations on the laboratory diagnosis of dengue, recognizing that a rapid diagnostic test detecting the NS1 antigen can be used to confirm a case of dengue in high-prevalence settings.
The GHM Dengue NS1 / IgG / IgM Combo Rapid Test US delivers qualitative results in just 15 minutes, supporting rapid clinical decision-making at the point of care. The test enables healthcare professionals to identify dengue infection across all major stages — from early acute phase to later antibody response — reducing the need for multiple separate tests and improving diagnostic efficiency. The test is compatible with whole blood, serum, and plasma 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 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
3-in-1 Combo Detection – NS1 Antigen, IgM, and IgG in One Test
The GHM Dengue NS1 / IgG / IgM Combo Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating dengue virus NS1 antigen, IgM antibodies, and IgG antibodies from a single patient sample. This triple detection capability helps healthcare providers evaluate the infection phase and distinguish between acute/primary infection and past or secondary infection, supporting appropriate clinical management and timely intervention. The test targets antigens from all four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4).
| Feature | Benefit |
|---|---|
| 3-in-1 combo detection | Simultaneously detects dengue NS1 antigen, IgM, and IgG antibodies in one test |
| Differentiation capability | Distinguishes acute/primary from past or secondary infection |
| Covers entire infection course | Provides comprehensive detection from Day 1 through the convalescent phase |
| Single-sample workflow | Reduces the need for multiple specimen collections and separate tests |
| Detects all four dengue serotypes | Comprehensive coverage of circulating dengue strains |
| Colloidal gold immunochromatography | Established and reliable detection method |
Fast Results – 15 Minutes
The GHM Dengue NS1 / IgG / IgM 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 primary care clinics and emergency departments |
| Efficient workflow | Enables immediate patient triage and case management |
| Quick sample-to-result | Supports high-throughput testing environments |
Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection
The GHM Dengue NS1 / IgG / IgM Combo 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. Fingerstick whole blood must be tested immediately after collection for best results. 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 Diagnosis Across All Stages of Dengue Infection
The GHM Dengue NS1 / IgG / IgM Combo Rapid Test US is intended for use as an aid in the diagnosis of dengue virus infection. The test provides rapid serological and antigenic diagnosis, enabling timely clinical decision-making and supporting patient management across the full spectrum of dengue infection stages.
The combination of NS1 antigen and IgM/IgG antibody detection is particularly valuable when the timing of infection onset is unclear, as it provides comprehensive detection from Day 1 through the convalescent phase. NS1 positivity confirms active acute infection regardless of primary or secondary status. Isolated IgM positivity mostly indicates a recent primary dengue infection; isolated IgG positivity only suggests past dengue exposure; concurrent positive IgM and IgG results are highly suggestive of secondary dengue infection. Combining NS1 antigen with IgM/IgG antibody detection provides the best sensitivity in patients presenting at different times after fever onset.
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.
| Feature | Benefit |
|---|---|
| Active infection detection aid | Supports identification of acute dengue infection via NS1 antigen |
| Full-course detection capability | Covers early acute phase through convalescent phase |
| Primary vs. secondary infection differentiation | Helps distinguish primary acute infection from past or secondary infection |
| 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 / IgG / IgM Combo Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity across all three targets. Clinical evaluation against leading commercial tests and ELISA methods has demonstrated strong performance, making this assay a reliable tool for point-of-care diagnostics when correctly used.
| Target | Sensitivity | Specificity | Accuracy |
|---|---|---|---|
| Dengue NS1 Antigen | 95.7% | 98.3% | 97.7% |
| Dengue IgM Antibody | 98.21% | 99.18% | 99.0% |
| Dengue IgG Antibody | 80.3% | 97.42% | 93.65% |
Performance characteristics based on comparison with leading commercial tests and ELISA methods. Published evaluations of NS1/IgM/IgG combination rapid tests have demonstrated overall sensitivity and specificity suitable for routine clinical use, with combination testing achieving the best compromise of sensitivity and specificity for patients presenting at different times after fever onset.
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 / IgG / IgM 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 Dengue NS1 / IgG / IgM Combo Rapid Test US |
| Product Code | DENC-425a |
| Product Type | Dengue NS1 / IgG / IgM Combo Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection and differentiation of dengue virus NS1 antigen, IgG antibodies, and IgM antibodies in human whole blood, serum, or plasma specimens; used as an aid in the diagnosis of dengue virus infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Analytes | Dengue virus NS1 antigen (all four serotypes: DENV-1, DENV-2, DENV-3, DENV-4); Dengue virus IgG and IgM antibodies |
| Specimen | Whole Blood / Serum / Plasma |
| Time to Result | 15 minutes |
| Sensitivity | NS1: 95.7%; IgM: 98.21%; IgG: 80.3% |
| Specificity | NS1: 98.3%; IgM: 99.18%; IgG: 97.42% |
| Accuracy | NS1: 97.7%; IgM: 99.0%; IgG: 93.65% |
| 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 Size | 25 tests/kit |
| Kit Contents | Dengue IgG/IgM/NS1 Combo Test Cassette, Extraction Buffer, Dropper, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Dengue NS1 / IgG / IgM Combo Rapid Test US |
|---|---|
| 3-in-1 combo detection | Simultaneous detection of NS1 antigen, IgM, and IgG antibodies |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood / serum / plasma compatibility | Flexible and convenient sampling options |
| Covers entire infection course | Comprehensive detection from Day 1 through convalescent phase |
| Primary vs. secondary infection differentiation | Helps distinguish acute/primary from past or secondary infection |
| Detects all four dengue serotypes | Comprehensive coverage of circulating strains |
| High sensitivity and specificity | NS1: 95.7% sensitivity; IgM: 98.21% sensitivity; IgG: 97.42% specificity |
| Outbreak response support | Enables rapid case identification and patient triage during outbreaks |
| Dengue screening support | Suitable for screening programs in endemic areas |
| 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 / IgG / IgM 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.
