OnSite™ Duo Dengue Ag-IgG/IgM Rapid Test Kit, CE, 30 Tests

The OnSite® Duo Dengue Ag-IgG/IgM Rapid Test is a lateral flow immunoassay designed for the simultaneous detection and differentiation of:

• NS1 antigen (DENV-1, DENV-2, DENV-3, DENV-4) – indicates current infection
• IgM antibodies – indicates recent infection
• IgG antibodies – indicates recent or past infection

This dual-format antigen–antibody rapid test delivers a comprehensive dengue diagnostic solution in one cassette, supporting clinicians in identifying both acute and past infections. The test requires no specialized equipment, uses serum, plasma, or whole blood, and provides results in 20–25 minutes.

Key Features

• Three-in-One Detection: Differentiates NS1 antigen, IgM, and IgG antibodies in a single test.
• Broad Serotype Coverage: Detects NS1 antigen from all four dengue virus serotypes.
• Licensed Technology: Utilizes recombinant chimeric dengue virus antigen licensed from the US CDC.
• Specimen Flexibility: Works with serum, plasma, or whole blood.
• Rapid Turnaround: Results in 20–25 minutes.
• Reliable Storage: Stable at 2–30 °C with 24-month shelf life.
• No Equipment Required: Ideal for decentralized and field-based testing.

Clinical Performance

• Ag Test
  • Sensitivity: 100% (95% CI: 96.8–100%)
  • Specificity: 99.6% (95% CI: 97.6–99.9%)
• IgG Test
  • Sensitivity: 97.3% (95% CI: 86.2–99.5%)
  • Specificity: 99.3% (95% CI: 97.5–99.8%)
• IgM Test
  • Sensitivity: 96.9% (95% CI: 84.3–99.4%)
  • Specificity: 98.9% (95% CI: 96.9–99.6%)
• Cross-Reactivity: None observed with other common infections/conditions (chikungunya, HIV, HAV, HBV, HCV, CMV, typhoid, rubella, TB, ANA, HAMA, RF, etc.).

Kit Contents

• Individually sealed foil pouches with cassette + desiccant
• 5 µL capillary tubes (for IgG/IgM test)
• Plastic droppers (for Ag test)
• Sample diluent (REF SB-R0062, 5 mL/bottle)
• Instructions for use

Applications

• Clinical Diagnosis: Detect both acute and past dengue virus infections.
• Hospitals & Clinics: Rapid triage for febrile patients in endemic areas.
• Public Health Programs: Surveillance and outbreak response.
• Field Testing: Resource-limited or remote settings requiring portable diagnostics.
• Research & Epidemiology: Comprehensive antibody and antigen monitoring.

The OnSite® Duo Dengue Ag-IgG/IgM Rapid Test (R0062C) provides a comprehensive, reliable, and rapid diagnostic solution for dengue infections. By combining antigen (NS1) and antibody (IgG, IgM) detection in a single cassette, it enables differentiation between current, recent, and past infections. With excellent sensitivity, specificity, and ease of use, this test is ideal for clinical, field, and public health applications in dengue-endemic regions.