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Global Healthcare Medical
GHM Dengue IgG/IgM Rapid Test US – Qualitative Detection of Dengue Virus IgG & IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM Dengue IgG/IgM Rapid Test US – Qualitative Detection of Dengue Virus IgG & IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Dengue IgG/IgM Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Dengue IgG/IgM Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection of dengue virus IgG 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. Serological assays to detect specific IgM or IgG antibodies to dengue virus are widely available and can provide an alternative to virus isolation or polymerase chain reaction to support the diagnosis of dengue fever. IgM antibodies become detectable on days 3–5 of illness and last for 2–3 months, whereas IgG antibodies develop by the fourteenth day and last a lifetime. First-time (primary) dengue virus infections typically have a stronger and more specific IgM response; subsequent (secondary) infections show a weaker IgM response but a strong IgG response.
The GHM Dengue IgG/IgM Rapid Test US delivers qualitative results in just 15 minutes, supporting rapid clinical decision-making at the point of care. The test differentiates acute from past infection and 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
2-in-1 Detection – IgM and IgG in One Test
The GHM Dengue IgG/IgM Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating dengue virus IgM and IgG antibodies from a single patient sample. This dual detection capability helps healthcare providers distinguish between acute/primary infection and past or secondary infection, supporting appropriate clinical management and timely intervention.
| Feature | Benefit |
|---|---|
| 2-in-1 detection | Simultaneously detects dengue IgM and IgG antibodies in one test |
| Differentiation capability | Distinguishes acute/primary from past or secondary infection |
| Single-sample workflow | Reduces the need for multiple specimen collections |
| Colloidal gold immunochromatography | Established and reliable detection method |
| Qualitative visual result | Clear and interpretable test outcome |
Fast Results – 15 Minutes
The GHM Dengue IgG/IgM 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 assessment |
| Quick sample-to-result | Supports high-throughput testing environments |
Whole Blood / Serum / Plasma Compatibility – Flexible Sample Collection
The GHM Dengue IgG/IgM 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.
| Feature | Benefit |
|---|---|
| Whole blood / serum / plasma | Flexible sample collection options |
| Venipuncture or fingerstick whole blood | Suitable for different clinical settings |
| Simple procedure | Convenient for routine testing |
| No special equipment required | Streamlined workflow in clinical settings |
Clinical Utility – Aid for Diagnosis of Dengue Virus Infection
The GHM Dengue IgG/IgM Rapid Test US is intended for use as an aid in the diagnosis of dengue virus infection. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting patient management. IgM positivity suggests probable primary acute infection; isolated IgG positivity indicates past dengue exposure; concurrent IgM and IgG positivity is highly suggestive of secondary dengue infection.
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 recent or acute dengue infection |
| Primary vs. secondary infection differentiation | Helps distinguish primary acute infection from past or secondary infection |
| Dengue screening support | Suitable for screening programs in endemic areas |
| Outbreak response support | Enables rapid case identification during outbreaks |
| Clinical versatility | Useful across primary care clinics, hospitals, and emergency departments |
High Accuracy – Trusted Clinical Performance
The GHM Dengue IgG/IgM Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity across both IgM and IgG 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 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.
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 IgG/IgM 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 IgG/IgM Rapid Test US |
| Product Code | DEN-422a |
| Product Type | Dengue IgG/IgM Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection of dengue virus IgG 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 Antibodies | Dengue virus IgG and IgM antibodies |
| Specimen | Whole Blood / Serum / Plasma |
| Time to Result | 15 minutes |
| Sensitivity | Dengue IgM: 98.21%; Dengue IgG: 80.3% |
| Specificity | Dengue IgM: 99.18%; Dengue IgG: 97.42% |
| Accuracy | Dengue IgM: 99.0%; Dengue 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 Rapid Test Cassette, Buffer, Dropper, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Dengue IgG/IgM Rapid Test US |
|---|---|
| 2-in-1 detection | Simultaneous detection of dengue IgM and IgG antibodies |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood / serum / plasma compatibility | Flexible and convenient sampling options |
| Primary vs. secondary infection differentiation | Helps distinguish acute/primary from past or secondary infection |
| High sensitivity and specificity | 98.21% sensitivity and 99.18% specificity for IgM |
| Dengue screening support | Suitable for screening programs in endemic areas |
| 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 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 IgG/IgM 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.
