OnSite™ Dengue IgG/IgM Combo Rapid Test, CE, 30 Tests
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Specifications:
Application | Diagnostic Testing | ||
Storage Temperature | Room Temperature | ||
Product Type | Test Kit | Forms | Kit with Various components |
Product Brand | CTK Biotech | ||
Product Grade | Medical grade | ||
The OnSite® Dengue IgG/IgM Combo Rapid Test is a lateral flow immunoassay designed for the simultaneous detection and differentiation of IgG and IgM antibodies to dengue virus (DENV-1, DENV-2, DENV-3, DENV-4) in human serum, plasma, or whole blood. This non-invasive test delivers results in just 15 minutes, enabling rapid triage and diagnosis without the need for laboratory equipment.
By distinguishing between IgM (recent infection) and IgG (recent or past infection), the assay supports clinicians in identifying both acute and previous dengue virus infections, facilitating appropriate patient care decisions.
Key Features
- Two-in-One Detection: Differentiates IgG and IgM dengue antibodies.
- Broad Coverage: Detects all four dengue serotypes.
- Licensed Technology: Utilizes recombinant chimeric dengue virus antigen licensed from the US CDC.
- Specimen Flexibility: Works with serum, plasma, or whole blood.
- Rapid Results: Clear results in 15 minutes.
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Strong Clinical Accuracy:
- Sensitivity: 97.3% (95% CI: 85.8–99.9%)
- Specificity: 99.3% (95% CI: 97.5–99.9%)
- Cross-Reactivity: No cross-reactivity with HAV, HBV, HCV, HEV, HIV, H. pylori, CMV, Chagas, Rubella, T. gondii, Typhoid, T. pallidum, HAMA, or RF (up to 8,400 IU/mL).
- Stable & Convenient: 24-month shelf life, room temperature storage.
- No Equipment Required: Ideal for decentralized and field-based use.
Kit Contents
- Individually sealed foil pouches with cassette + desiccant
- 5 µL capillary tubes
- Sample diluent (REF SB-R0061, 5 mL/bottle)
- Instructions for use
Applications
- Clinical Diagnosis: Detect and stage dengue infections (recent vs past).
- Hospitals & Clinics: Rapid screening of febrile patients.
- Public Health Programs: Surveillance and outbreak response in endemic regions.
- Field Testing: Easy-to-use in resource-limited or mobile settings.
- Research & Epidemiology: Monitoring dengue prevalence and immunity.
The OnSite® Dengue IgG/IgM Combo Rapid Test (R0061C) is a fast, accurate, and practical solution for the detection and differentiation of dengue antibodies. With its high sensitivity and specificity, lack of cross-reactivity, and ability to identify both recent and past infections, it is an essential diagnostic tool for clinicians, laboratories, and public health teams in dengue-endemic regions.