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Global Healthcare Medical
GHM Chikungunya IgG/IgM Rapid Test US – Dual-Target Qualitative Detection of Chikungunya Virus IgG & IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
GHM Chikungunya IgG/IgM Rapid Test US – Dual-Target Qualitative Detection of Chikungunya Virus IgG & IgM Antibodies with 15-Minute Results, Whole Blood / Serum / Plasma Sample Compatibility, and Professional Point-of-Care Use
SKU: GHM Chikungunya IgG/IgM Rapid Test US
Brand: Global Healthcare Medical
Product Overview
Global Healthcare Medical GHM Chikungunya IgG/IgM Rapid Test US is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of IgG and IgM antibodies to chikungunya virus (CHIKV) in human whole blood, serum, or plasma specimens. The kit is intended for use by healthcare professionals as a screening test and as an aid in the diagnosis of chikungunya virus infection.
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), an RNA virus belonging to the Alphavirus genus of the Togaviridae family. The virus is transmitted to humans primarily through the bites of infected Aedes aegypti and Aedes albopictus mosquitoes. Chikungunya typically presents with sudden onset of fever and severe joint pain, often accompanied by muscle pain, headache, nausea, fatigue, and rash. While the acute phase of infection generally resolves within one to two weeks, a substantial proportion of patients experience chronic arthralgia that can persist for months or even years, accounting for 54% of the total chikungunya burden.
The global burden of chikungunya has escalated dramatically in recent years. In 2025, a resurgence of chikungunya virus disease was noted in multiple countries, with 445,271 suspected and confirmed cases and 155 deaths reported globally from 40 countries between 1 January and 30 September 2025. Prior to 2025, autochthonous transmission had been reported from 119 countries and territories across six WHO regions. The potential for further geographic spread remains significant due to the expanded distribution of Aedes mosquitoes, climate change, increased human mobility, and gaps in surveillance and diagnostic capacity. Early detection of cases and timely access to appropriate medical care are essential for minimizing clinical complications and reducing mortality.
The clinical presentation of chikungunya overlaps significantly with other arboviral diseases such as dengue, Zika, and yellow fever, making laboratory confirmation essential for accurate diagnosis. Because commercial immunochromatographic test kits for CHIKV remain scarce, rapid point-of-care testing plays a critical role in decentralizing diagnosis and improving access to testing at lower healthcare system levels.
The GHM Chikungunya IgG/IgM 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 (venipuncture or fingerstick), serum, and plasma specimens, providing flexible sample collection options suitable for a wide range of clinical settings, including decentralized and resource-limited environments where laboratory infrastructure may be limited.
The kit is intended for in vitro diagnostic use and professional use only, suitable for application scenarios including physician office laboratories, hospital laboratories, public health screening programs in endemic areas, travel medicine clinics, 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
2-in-1 Detection – IgG and IgM in One Test
The GHM Chikungunya IgG/IgM Rapid Test US utilizes a lateral flow immunochromatographic assay capable of simultaneously detecting and differentiating chikungunya virus IgG and IgM antibodies from a single patient sample. The test incorporates two separate test lines: T1 for IgG and T2 for IgM, enabling clear differentiation between acute/recent infection and past infection or immunity in a single assay. This dual-target design provides a comprehensive diagnostic picture that supports appropriate clinical decision-making and effective patient management.
| Feature | Benefit |
|---|---|
| 2-in-1 detection | Simultaneously detects chikungunya IgG and IgM antibodies in one test |
| Two separate test lines (T1 & T2) | Clear differentiation between acute/recent infection and past infection |
| Single-sample workflow | Reduces the need for multiple specimen collections and separate tests |
| Colloidal gold immunochromatography | Established and reliable detection method |
| Recombinant CHIKV antigen-coated gold particles | Targeted detection of chikungunya antibodies |
| Qualitative visual result | Clear and interpretable test outcome |
Fast Results – 15 Minutes
The GHM Chikungunya 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. Rapid diagnostic tests for chikungunya enable faster case identification and support timely clinical management.
| Feature | Benefit |
|---|---|
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Point-of-care compatibility | Suitable for physician office laboratories and travel medicine clinics |
| 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 Chikungunya 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. The test requires only a small sample volume, making it suitable for both clinic-based and field-based testing scenarios in resource-limited settings.
| Feature | Benefit |
|---|---|
| Whole blood / serum / plasma | Flexible sample collection options |
| Fingerstick or venipuncture whole blood | Suitable 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 Chikungunya Virus Infection
The GHM Chikungunya IgG/IgM Rapid Test US is intended for use as a screening test and as an aid in the diagnosis of infection with chikungunya virus. The test provides rapid serological diagnosis, enabling timely clinical decision-making and supporting patient management.
The dual-target design provides comprehensive diagnostic value. IgM antibodies are typically detectable within 3–5 days after symptom onset and may persist for several weeks to months, indicating acute or recent infection. IgG antibodies generally appear within 1–2 weeks after infection and persist for years, indicating past infection or immunity. The presence of both IgM and IgG may indicate a recent infection in a later stage. Because the clinical presentation of chikungunya overlaps significantly with dengue, Zika, and other arboviral diseases, laboratory confirmation through serological testing is essential for accurate differential diagnosis.
The test is particularly valuable in settings where rapid identification of chikungunya infection supports clinical management and public health intervention. Early detection of cases and timely access to appropriate medical care are essential for minimizing clinical complications and reducing mortality. The test is also suitable for use in decentralized testing environments where laboratory infrastructure may be limited.
| Feature | Benefit |
|---|---|
| Acute/recent infection detection aid | Supports identification of acute or recent CHIKV infection via IgM detection |
| Past infection detection support | Identifies past chikungunya infection or immunity via IgG detection |
| Screening utility | Suitable for use as a screening test in clinical and public health settings |
| Differential diagnosis support | Helps distinguish chikungunya from dengue, Zika, and other arboviral infections |
| Public health screening support | Suitable for surveillance and outbreak response programs |
| Clinical versatility | Useful across physician offices, hospitals, travel clinics, and public health settings |
High Accuracy – Trusted Clinical Performance
The GHM Chikungunya IgG/IgM Rapid Test US is designed to deliver reliable clinical performance with high sensitivity and specificity for both IgG and IgM targets. Clinical evaluation against reference methods has demonstrated strong performance, making this assay a valuable tool for point-of-care diagnostics when correctly used.
| Parameter | Specification |
|---|---|
| Sensitivity | 96.9% |
| Specificity | 98.6% |
| Specimen | Whole Blood / Serum / Plasma |
| Time to Result | 15 minutes |
Performance characteristics based on evaluations of rapid chikungunya antibody tests. Published evaluations of rapid chikungunya tests in scenarios of Zika and dengue co-circulation in Brazil reported accuracy of 97.7%, with specificity and sensitivity of 97.9% and 96.8%, respectively, concluding that the rapid test has high performance for detecting CHIKV infection in co-circulation scenarios. Systematic reviews of rapid diagnostic tests for chikungunya have demonstrated that IgG detection tests achieve performance exceeding 93% regardless of the timing of sample collection. Detection is optimal when specimens are collected at appropriate time points during infection, and the test is best suited for use as an aid in the diagnosis of chikungunya in symptomatic patients.
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 Chikungunya 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 Chikungunya IgG/IgM Rapid Test US |
| Product Code | ICHI-402 |
| Product Type | Chikungunya IgG/IgM Rapid Test (Colloidal Gold) |
| Intended Use | Qualitative detection and differentiation of IgG and IgM antibodies to chikungunya virus (CHIKV) in human whole blood, serum, or plasma specimens; used as a screening test and as an aid in the diagnosis of chikungunya virus infection |
| Detection Principle | Lateral flow immunochromatography; colloidal gold immunoassay |
| Target Antibodies | Chikungunya virus IgG and IgM antibodies |
| Specimen | Whole Blood (venipuncture or fingerstick) / Serum / Plasma |
| Time to Result | 15 minutes |
| Sensitivity | 96.9% |
| Specificity | 98.6% |
| Storage Temperature | 2–30°C (35.6–86°F) |
| Shelf Life | 24 months |
| Application Scenario | Physician office laboratory, hospital laboratory, travel medicine clinic, public health screening program in endemic areas, clinical laboratory, point-of-care |
| Regulatory Status | Manufactured under EN ISO 13485 certified quality management system; CE marked |
| Intended User | Professional healthcare use only |
| Kit Sizes | 25 tests/kit; 40 tests/kit |
| Kit Contents | Chikungunya IgG/IgM Test Cassette, Sample Buffer, Disposable Droppers, Instructions for Use |
Why Clinical Professionals Choose Global Healthcare Medical
| Consideration | GHM Chikungunya IgG/IgM Rapid Test US |
|---|---|
| 2-in-1 detection | Simultaneous detection and differentiation of chikungunya IgG and IgM antibodies |
| 15-minute test time | Rapid turnaround for timely clinical decisions |
| Whole blood / serum / plasma compatibility | Flexible and convenient sampling options |
| Two separate test lines (T1 & T2) | Clear differentiation between acute/recent infection and past infection |
| High sensitivity and specificity | 96.9% sensitivity and 98.6% specificity |
| High accuracy in co-circulation settings | 97.7% accuracy demonstrated in Zika and dengue co-circulation scenarios |
| Differential diagnosis support | Helps distinguish chikungunya from dengue, Zika, and other arboviral infections |
| Screening test utility | Suitable for use as a screening test in clinical and public health settings |
| Public health screening support | Suitable for surveillance and outbreak response programs |
| ISO 13485 certified | Quality management system compliance |
| CE marked | Regulatory compliance for professional use |
| Point-of-care compatible | Suitable for physician offices, hospitals, travel clinics, and public health 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 Chikungunya 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.
